Thailand
Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Specimen Import & Export
QUICK FACTS
Clinical trial application language Unspecified
Regulatory authority & ethics committee review may be conducted at the same time Yes
Clinical trial registration required No
In-country sponsor presence/representation required Unclear
Age of minors Under 20
Specimens export allowed Unspecified
Regulatory Authority > Regulatory Authority
Last content review/update: August 29, 2019
Requirements
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct – Thai) (Last Amended April 16, 2019) (Effective Date: October 13, 2019)
National Assembly
Relevant Sections: Section 4, Chapter I (6-7, 10-11), Chapter II (12), and Chapter V (46)
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface and Appendices 1-4
(3) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
Relevant Sections: Article 2 (Clause 3)
(4) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (June 19, 2009) (Effective Date: July 9, 2009)
Ministry of Public Health
Relevant Sections: Article 1 (Clauses 2 and 3)
(5) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (May 28, 2018) (Effective Date: September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface
(6) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface and 3
(7) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (WHO 1) (PubGuide-ClinDrugReqs - Thai) (Effective Date: 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(8) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research Biomedical Case (1) (PubGuide-ClinBiolProdReqs - Thai) (Effective Date: 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(9) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Announcement: 2; Notice: Preface, 2-3, and 5
Summary

Overview

As per the DrugAct, TFDA-ClinDrugReqs, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, and TFDA-ClinDrugImprt2017, the Thai Food and Drug Administration (Thai FDA) is the regulatory authority responsible for controlling the import of drugs for research purposes, and also uses this authority to indirectly regulate drug clinical trials in humans.

As set forth in the DrugAct and Additional Resources (A) and (B), the Thai FDA is a regulatory body under the Ministry of Public Health (MOPH)’s Cluster of Public Health Service Support, and is granted control by the MOPH to protect consumer health. The agency is also authorized to ensure the quality, safety, and efficacy of health products including foods, drugs, cosmetics, and medical devices in Thailand.

In addition, per the DrugAct’s 2019 amendments scheduled to go into effect on October 13, 2019, and Additional Resource (C), the MOPH will soon have the authority to establish and/or amend drug research-related procedures, regulations, and conditions via Government Gazette announcements. The Thai FDA’s Secretary-General will also be permitted to control drug research study activities through issuing temporary suspensions, requests for specific improvements, or completely discontinuing a study that fails to comply with the Minister’s published guidelines.

According to the DrugAct and Additional Resource (D), the Thai FDA’s Bureau of Drug Control is a member of the Drug Board (also referred to as the Drug Committee in the English translation of the DrugAct). The board must consist of MOPH departmental directors-general and representatives from related organizations, as well as five (5) to nine (9) drug experts. Every two (2) years, the Minister of Public Health appoints the Committee, which is chaired by the Permanent Secretary of the MOPH. The 14 members of the board have appointed 20 subcommittees to assist in the board’s responsibility for advising the Minister on regulatory issues and ensuring drug control. Of these subcommittees, the subcommittee on approval of manufacturing or importing medicines for clinical studies is directly involved with the clinical trial and drug import registration process.

The DrugAct also indicates that the board should now appoint a subcommittee to study the drug review and approval process. The subcommittee should include at least the following: an office representative and Office of Consumer Protection Board representatives including association, foundation, and drug industry representatives whose purpose is to produce, sell, import, or order drugs for use in Thailand. Additional Resource (D) provides the current list of subcommittees to which this new subcommittee will be added.

According to Additional Resources (E) and (F), the Thai FDA’s International Affairs and Investigational New Drug Section within the Bureau of Drug Control is responsible for application review and recommendation for approval. The Thai FDA then makes the final decision to approve the application.

As explained in TFDA-ClinDrugImprt2017, the Thai FDA has also established the Institute for the Promotion of Health Product Innovation to carry out activities related to the manufacture and import of drugs for research and to develop related requirements. This profile will be updated as more information becomes available.

Contact Information

Bureau of Drug Control
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanon Road
Mueang District
Nonthaburi 11000
Thailand
Phone: Int. +66 2 590-7171 or Int. +66 2 590-7160
Fax: Int. +66 2 590-7170, +66 2 591-8390, or +66 2 591-8489
Email: drug@fda.moph.go.th

Additional Resources
(A) (Website) Organization Structure of Thai FDA (Current as of August 27, 2019)
Thai Food and Drug Administration, Ministry of Public Health
(B) (Website) The Roles and Responsibilities of Thai FDA (Current as of August 27, 2019)
Thai Food and Drug Administration, Ministry of Public Health
(C) (Article) Amendments to Thailand’s Drug Act (May 21, 2019)
Homhuan, Atthachai; Tilleke & Gibbons
Relevant Sections: Guidelines for Clinical Research Compliance
(D) (Website) Bureau of Drug Control - Laws and Regulations (Current as of August 27, 2019)
Thai Food and Drug Administration, Ministry of Public Health
Thai Food and Drug Administration, Ministry of Public Health
Thai Food and Drug Administration, Ministry of Public Health
Practical Law
Relevant Sections: Clinical Trials
Regulatory Authority > Scope of Assessment
Last content review/update: August 29, 2019
Requirements
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct – Thai) (Last Amended April 16, 2019) (Effective Date: October 13, 2019)
National Assembly
Relevant Sections: Section 4, Chapter I (10), Chapter II (12, and 17-18), and Chapter V (46)
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 1.2-1.3, 1.10, 1.12-1.13, 3, and Appendices 1-7, and 13
(3) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
Relevant Sections: Article 2 (Clause 3)
(4) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (June 19, 2009) (Effective Date: July 9, 2009)
Ministry of Public Health
Relevant Sections: Article 1 (Clauses 2 and 3)
(5) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (May 28, 2018) (Effective Date: September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface and 4
(6) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 2-4, and 6
(7) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (WHO 1) (PubGuide-ClinDrugReqs - Thai) (Effective Date: 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(8) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research Biomedical Case (1) (PubGuide-ClinBiolProdReqs - Thai) (Effective Date: 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(9) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Announcement: 1; Notice: Preface, 2-3, and 5
(10) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 7
(11) (Regulation) Notification of Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 5, 9-10
Summary

Overview

In accordance with the DrugAct, TFDA-ClinDrugReqs, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, and TFDA-ClinDrugImprt2017, the Thai Food and Drug Administration (Thai FDA) is responsible for overseeing the importation or ordering of drugs for clinical research purposes, and also uses this authority to indirectly regulate drug clinical trials in humans. As per G-ResEthics, the scope of the Thai FDA’s assessment includes Phases I through IV clinical trials for new drugs (also referred to as “modern drugs”), traditional drugs (drugs intended for use in the practice of traditional medicine or to cure animal disease), unregistered drugs, registered drugs being studied in new doses or for indications not previously approved, and locally produced drugs that require efficacy testing.

As indicated in TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017, and ECReg&Proc-2018, the Thai FDA’s approval of a drug importation license is dependent upon obtaining proof of ethics committee (EC) approval to conduct the clinical trial by a Thai FDA approved institutional EC. Per TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the EC approval can be submitted to the Thai FDA after the rest of the application has been submitted for review. Therefore, the Thai FDA and EC may conduct their reviews in parallel.

Clinical Trial Review Process

As set forth in TFDA-ClinDrugReqs, TFDA-ClinDrugProdReqs, and described in Additional Resource (A), the Thai FDA coordinates the review of applications submitted to obtain drug import licenses for clinical trial purposes. Per PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, and Additional Resource (B), upon receipt of an application package, the Thai FDA’s One Stop Service & Consultation Center sends the application package to an officer in the Thai FDA’s International Affairs and Investigational New Drug Section. The officer then screens the package for completeness and informs the eligible sponsor of the results within five (5) working days from the date the application was received. If deemed complete, the officer sends the package to the assigned technical reviewer. If the reviewer determines that the application package meets the appropriate technical requirements, he/she will forward his/her recommendations to the Thai FDA, which is authorized to approve the application.

TFDA-ClinDrugReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugLicenseReqs, and TFDA-ClinDrugImprt2017 also explain that once the Thai FDA receives the EC approval documentation, the agency will complete its review within 15 days.

According to TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the import license will expire in four (4) years from the date of issuance. TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017 further note that if the study is still ongoing after the expiry date or the amount of drug is insufficient, the sponsor can resubmit the application. The DrugAct states that the issued license shall also cover the license holder’s employees or agents.

As indicated in the DrugAct, a license will remain valid until December 31st of the year of issue. The license holder who would like to renew his/her license must file an application for renewal prior to the license expiration date. Once the renewal application has been filed, the license holder may continue to conduct business unless his/her renewal request is denied. A license holder whose license has expired for not more than one (1) month may file an exemption indicating the reason for obtaining a license extension. However, an application renewal request submitted after one (1) month from the date of license expiration is not permitted. In the event that the Thai FDA does not issue or grant a license renewal request, the sponsor may appeal in writing to the Minister within 30 days from the date of receiving the notice rejecting his/her request. The sponsor may obtain a temporary license to operate his/her business until the Minister issues a final decision.

(See the Clinical Trial Lifecycle topic, Submission Content subtopic for submission requirements.)

Additional Resources
Practical Law
Relevant Sections: Clinical Trials
Thai Food and Drug Administration, Ministry of Public Health
(C) (Website) Thai FDA - One Stop Service & Consultation Center (English and Thai) (Current as of August 27, 2019)
Thai Food and Drug Administration, Ministry of Public Health
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Regulatory Authority > Regulatory Fees
Last content review/update: August 29, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

Clinical trial application fee information is currently not available from the Thai Food and Drug Administration (Thai FDA). However, according to Additional Resource (A), charges for the import license application in 2016 were approximately 25000 Thailand Baht.

Additional Resources
Credevo
Relevant Sections: Documents Required
Ethics Committee > Ethics Committee
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.1-1.3, 1.10- 1.12, 1.15, 5, and Appendices 1-7, 13, and 15
(2) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (May 28, 2018) (Effective Date: September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(4) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Announcement: 1; Notice: 4
(5) (Regulation) Notification of Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4-6 and 9-10
(6) (Legislation) Hospital Act, B.E. 2541 (HospitalAct – English, unofficial translation) (Thai) (March 15, 1998)
National Assembly
(7) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Chapter 6
(8) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.27 and 3.3
Summary

Overview

As per TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017, and ECReg&Proc-2018, clinical trials require institutional ethics committee (EC) approval for each trial site from an EC recognized by the Thai Food and Drug Administration (Thai FDA). ECReg&Proc-2018 indicates that ECs may be a committee under the Ministry of Public Health (MOPH), a private hospital/institution licensed to comply with the HospitalAct, or a non-profit partnership of the MOPH. Additional Resource (A) also notes that ECs are usually based in hospitals or university medical institutions.

As delineated in TFDA-ClinDrugReqs and ECReg&Proc-2018, the EC is responsible for reviewing and approving protocols for clinical research involving drugs to be imported into Thailand. According to TFDA-ClinDrugReqs and ECReg&Proc-2018, once the clinical protocol has been approved, the Thai FDA will review the drug import license application for the study drug that must only be used at the specific study site approved by the EC.

According to Additional Resource (B), the Thai FDA has currently approved nine (9) ECs, including the MOPH’s Ethical Review Committee for Research in Human Subjects (ERC). As indicated in ECReg&Proc-2018, the Thai FDA posts a list of the approved ECs on its website. Because each EC has its own requirements, it is recommended that the individual ECs be contacted to confirm their specific requirements. Additional Resource (A) further explains that a sponsor must obtain EC approval from the MOPH (ERC) and/or the hospital or university EC overseeing the trial. However, if an approval is obtained from the hospital or university EC, MOPH (ERC) approval is usually optional, unless further required by the institution’s internal rules and regulations.

Per TFDA-ClinDrugReqs, the MOPH may also establish an academic EC or subcommittee for research on certain drugs requiring special supervision (e.g., for AIDS vaccines and drugs derived from cells). Therefore, when submitting an application to request permission to import or order this type of drug for clinical research, an additional approval letter from this special committee is also required.

As indicated in Additional Resource (C), the MOPH’s ERC is also responsible for controlling, supervising, and conducting research in accordance with international ethical principles; developing research policy; creating a national database of clinical research; and reviewing and approving clinical research projects for human subjects approval.

EC Composition

As per G-ResEthics, institutional ECs should consist of at least five (5) members, both male and female, with the following qualifications:

  • At least one (1) member with knowledge and experience in research fields regularly reviewed (e.g., medicine, public health, social science, etc.)
  • At least one (1) member who is a lawyer or has legal expertise
  • At least one (1) member who is unaffiliated with the institution, and, if possible, that member should be selected from the community where the institution is based
  • At least two (2) members who have patient care, counseling, and treatment knowledge and experience
  • At least one third of the total EC should be knowledgeable or trained in human research ethics

ECReg&Proc-2018, by comparison, also requires institutional ECs to have at least five (5) members who are experts on science, medicine, and ethics. In addition, the committee must include members representing the following qualifications:

  • At least three (3) members who are medical professionals
  • At least one (1) member must be an expert in a non-scientific category
  • At least one (1) member from outside of the institution where the trial is taking place

The Thai-GCPs similarly indicates that ECs should be composed of medical personnel, scientists, and non-scientists, and also notes that while these committees may have differences in legal status, composition, and function, the duties of an EC should be consistent with the Thai-GCPs.

Terms of Reference, Review Procedures, and Meeting Schedule

As delineated in G-ResEthics and ECReg&Proc-2018, ECs must conduct clinical protocol reviews according to the Thai-GCPs, using written standard operating procedures (SOPs) that are periodically updated, and develop a process for conducting reviews. The SOPs should include information on EC composition, meeting schedules, timeframes for protocol reviews, quorum requirements, decision-making procedures, channels of communicating the decision(s), complaint processes, reviewing fees (if any), protection of protocol confidentiality, and prevention of possible conflicts of interests. The G-ResEthics also states that each EC must establish the composition, member terms of service, and criteria for selecting the committee members, as appropriate. The members must also be appointed officially as evidenced by a written document.

(For detailed EC requirements and information on other administrative processes, see G-ResEthics and ECReg&Proc-2018.)

Additional Resources
Practical Law
Relevant Sections: Clinical Trials
Thai Food and Drug Administration, Ministry of Public Health
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(E) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.27 and 3.3
Ethics Committee > Scope of Review
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Chapter 2, 4, and 6
(2) (Regulation) Notification of Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 5-6
(3) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.27 and 3.3
(4) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.2-1.3, 1.9-1.10, 1.12, 3, and Appendices 1-7, and 13
(5) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (August 24, 2016) (Effective Date: October 1, 2016)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(6) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(7) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Announcement: 1; Notice: 4
Summary

Overview

As stated in G-ResEthics, ECReg&Proc-2018, and the Thai-GCPs, the primary scope of information assessed by the Thai Food and Drug Administration (Thai FDA) recognized institutional ethics committees (ECs), including the Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC), relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. The ECs must also pay special attention to reviewing informed consent and protecting the welfare of certain classes of participants deemed to be vulnerable. (See Informed Consent topic, and the subtopics of Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses, and Neonates; Prisoners; and Mentally Impaired for additional information about these populations).

The ECs are also responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. The ECs must act in the interests of the potential research participants and the communities involved, evaluating the possible risks and expected benefits to participants; confirming the suitability of the investigator(s), facilities, and methods; and verifying the adequacy of confidentiality and privacy safeguards. G-ResEthics further states that ECs should review the ethical aspects of the protocol in compliance with current international ethical guidelines taking into account local or national laws, religions, traditions, and cultures. See G-ResEthics, ECReg&Proc-2018, and the Thai-GCPs for detailed ethical review guidelines. Also, see Additional Resource (A) for details specific to the MOPH ERC.

Role in Clinical Trial Approval Process

As stated in TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017, and ECReg&Proc-2018, the Thai FDA’s approval of a drug import license application to conduct a clinical trial is dependent upon obtaining approval by a Thai FDA approved institutional EC. Per TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, and TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the EC approval can be submitted to the Thai FDA after the rest of the application has been submitted for review. Therefore, the Thai FDA and EC may conduct their reviews in parallel.

TFDA-ClinDrugReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugLicenseReqs, and TFDA-ClinDrugImprt2017 also explain that once the Thai FDA receives the EC approval documentation, the agency will complete its review within 15 days.

Additional Resource (B) further notes that a sponsor must obtain EC approval from MOPH (ERC) and/or the hospital/institutional EC overseeing the trial. However, if an approval is obtained from the hospital/institutional EC, MOPH (ERC) approval is usually optional, unless further required by the institution’s internal rules and regulations.

In the instance of a multicenter clinical trial, G-ResEthics indicates that protocols submitted to each institution’s EC should contain the same content substance and details, and should specify the quality control techniques to ensure that research practices are the same in each institution. Although each institutional EC may independently approve or disapprove an application, G-ResEthics advises the committees from each participating institution to consult with one another to reach a clearly agreed upon decision.

There is no stated expiration date for an EC approval in G-ResEthics or Additional Resource (A).

Additional Resources
(A) (ERC Guidelines) Guidelines and Procedures for Conducting Research on Human Subjects (Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Instruction for the Submission of a Study/Research Proposal to be Reviewed by The Ethic Review Committee for Research in Human Subject, Ministry of Public Health (p.63)
Practical Law
Relevant Sections: Clinical Trials
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(D) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.27 and 3.3
(E) (WMA Guidance) Declaration of Helsinki (Thai) (October 19, 2013)
World Medical Association
(F) (Document) Nuremberg Code (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Council for International Organizations of Medical Sciences (CIOMS)
Nuffield Council on Bioethics
Ethics Committee > Ethics Committee Fees
Last content review/update: August 29, 2019
Requirements
No applicable regulatory requirements
Summary

No relevant provisions.

Additional Resources
No additional resources
Ethics Committee > Authorizing Body
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 4-6, 9, and 11
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.2-1.3, 1.10, 1.12, and Appendices 1-6, 13, and 15
(3) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (May 28, 2018) (Effective Date: September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(4) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(5) (Legislation) Hospital Act, B.E. 2541 (HospitalAct – English, unofficial translation) (Thai) (March 15, 1998)
National Assembly
Summary

Overview

As indicated in ECReg&Proc-2018, TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, and TFDA-ClinDrugProdReqs, institutional ethics committees (ECs), including the Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC), must be authorized by the Thai Food and Drug Administration (Thai FDA) to conduct ethical reviews of drug clinical trials. TFDA-ClinDrugReqs and ECReg&Proc-2018 state authorized ECs are responsible for reviewing and approving protocols for clinical research involving drugs to be imported into Thailand.

Per the ECReg&Proc-2018, authorized ECs must be a committee under the MOPH, a private institution/hospital licensed to comply with the HospitalAct, or a non-profit partnership of the MOPH. Additionally, these ECs must meet the following requirements:

  • Be qualified according to the laws or government regulations related to research or service related to the research
  • Have a clearly defined structure with proof of appropriately appointed members including the secretary and secretariat
  • Have voting rights and the right to issue independent research opinions without investigator/sponsor involvement, and with no direct or indirect interest or conflict of interest with the investigator or clinical research study
  • Be trained in conducting research and clinical trials in human subjects and have training in ethics or other related training at least once every two (2) years while serving on the committee
  • Have experience in reviewing human research involving experimental drugs for at least 10 studies

As per the ECReg&Proc-2018, the acceptance letter issued by the Thai FDA is valid for two (2) years using Jor Thor Form 1 (Additional Resource (B)). Each EC is required to submit an annual report (Additional Resource (C)) to the Thai FDA and to apply for an acceptance extension by 60 days before the expiry date.

Additional Resources
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Clinical Trial Lifecycle > Submission Process
Last content review/update: August 29, 2019
Requirements
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct – Thai) (Last Amended April 16, 2019) (Effective Date: October 13, 2019)
National Assembly
Relevant Sections: Section 4
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface 1.2-1.3, 1.5-1.6, 1.8, 1.10, 1.12, and Appendices 1-8, 11, 13, and 15
(3) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
Relevant Sections: Article 2 (Clause 3)
(4) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (June 19, 2009) (Effective Date: July 9, 2009)
Ministry of Public Health
Relevant Sections: Article 1 (Clauses 2 and 3)
(5) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (May 28, 2018) (Effective Date: September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface and 4
(6) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (WHO 1) (PubGuide-ClinDrugReqs - Thai) (Effective Date: 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(7) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research Biomedical Case (1) (PubGuide-ClinBiolProdReqs - Thai) (Effective Date: 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(8) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface and 3-4
(9) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Announcement:1; Notice: Preface and 2-3
(10) (Regulation) Notification of Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 5 and Form EC-1
(11) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 6.1
Summary

Overview

In accordance with the DrugAct, TFDA-ClinDrugReqs, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the Thai Food and Drug Administration (Thai FDA) is responsible for overseeing the import of drugs for research purposes, and also uses this authority to indirectly regulate drug clinical trials in humans. As set forth in in TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and ECReg&Proc-2018, the Thai FDA’s review and approval of a drug importation license is dependent upon obtaining proof of ethics committee (EC) approval to conduct the clinical trial by a Thai FDA approved EC. Per TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the EC approval can be submitted to the Thai FDA after the rest of the application has been submitted for review. Therefore, the Thai FDA and EC may conduct their reviews in parallel.

Delivery Address for Clinical Trial Application

PubGuide-ClinDrugReqs provides the most complete address information regarding submitting the application to be screened by the Thai FDA’s One Stop Service & Consultation Center, followed by where to submit the application for review and approval by the Thai FDA’s Bureau of Drug Control review. Additional Resource (A) provides access to the clinical trial/drug import license application form, which is referred to as the Health Product Classification application form or the NorYorMor1 application form by the Thai FDA.

Applications should be submitted to:

One Stop Service & Consultation Center
Food and Drug Administration, 1st Floor
Ministry of Public Health
88/24 Tiwanon Road
Mueang District
Nonthaburi 11000
Thailand
Phone: +66 2 590-74124

To track status and get the result of the application:

Food and Drug Administration
Research Building 2, Floor 3, Room 315
Ministry of Public Health
88/24 Tiwanon Road
Mueang District
Nonthaburi 11000
Thailand
Phone: +66 2 590-7061

Assembly and Number of Copies

As per TFDA-ClinDrugReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, and Additional Resource (C), sponsors must submit two (2) original sets and one (1) copy of the completed Health Product Classification (NorYorMor1) application form (Additional Resource (A)) to the Thai FDA as well as one (1) complete set of application files (MS Word or PDF) on a CD. The files should be arranged in the order that corresponds with the document checklist (Appendix 3 of TFDA-ClinDrugReqs). Per TFDA-ClinDrugReqs, the CD should also include copies of all the filed documents (Microsoft Word and PDF files), Microsoft Excel files for the Logistic Systems, and the manufacturer’s files to be completed on Form 11.1 (refer to Appendix 8 - Quality control and drug production documents).

According to Additional Resource (D), the Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC) requires one (1) original and 20 copies of the protocol to be submitted in Thai, and one (1) copy be submitted in English for review purposes. The MOPH ERC is one of the ECs approved by the Thai FDA to review and approve clinical trial protocols.

Per G-ResEthics, each EC should establish its own requirements for protocol submission along with the required documents including the application, number of research protocol copies to be submitted, the patient information sheet, the informed consent form, and the case report form. Each EC should also communicate to personnel or staff within the institution.

Language Requirements

TFDA-ClinDrugReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, and Additional Resources (C) and (E) indicate that Thai and English are the preferred languages for use in preparing an application package. The following requirements are specified: the packaging and labeling information should be presented in Thai or English; the protocol synopsis must be submitted in Thai; the detailed study protocol specification may be in Thai or English; the patient information sheet must be in Thai; per TFDA-ClinDrugReqs, drug labels of all sizes in Thai or English; the Certificate of Free Sale must also be presented in English and translated by a trusted certification authority and any other language in which it has been originally issued; and the progress report must be submitted in Thai.

According to Additional Resource (D), the MOPH ERC requires the protocol to be submitted in Thai. One (1) copy may be provided in English for review.

Additional Resources
Thai Food and Drug Administration, Ministry of Public Health
(B) (Website) Thai FDA - One Stop Service & Consultation Center (English and Thai) (Current as of August 27, 2019)
Thai Food and Drug Administration, Ministry of Public Health
Thai Food and Drug Administration, Ministry of Public Health
(D) (ERC Guidelines) Guidelines and Procedures for Conducting Research on Human Subjects (Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Guidelines for the preparation of a research proposal submitted to the Ethical Review Committee for Research on Human Subjects, Ministry of Public Health (p.67)
Practical Law
Relevant Sections: Clinical Trials
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Clinical Trial Lifecycle > Submission Content
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.1-1.4, 1.10, 1.12, 3, and Appendices 1-7, and 13
(2) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
Relevant Sections: Article 2 (Clause 3)
(3) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (June 19, 2009) (Effective Date: July 9, 2009)
Ministry of Public Health
Relevant Sections: Article 1 (Clauses 2 and 3)
(4) (Regulation) Notification of Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 5
(5) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (August 24, 2016) (Effective Date: October 1, 2016)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1 and 4
(6) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (WHO 1) (PubGuide-ClinDrugReqs - Thai) (Effective Date: 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface and Appendices 1-5
(7) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research Biomedical Case (1) (PubGuide-ClinBiolProdReqs - Thai) (Effective Date: 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(8) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(9) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Announcement: 1; Notice: 4
(10) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 6
(11) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 6
Summary

Overview

As set forth in TFDA-ClinDrugReqs, DrugImprtRules-1989, DrugImprtRules-2009, ECReg&Proc-2018, TFDA-ClinDrugLicenseReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the Thai Food and Drug Administration (Thai FDA)’s approval of a drug importation license is dependent upon obtaining proof of ethics committee (EC) approval to conduct the clinical trial by a Thai FDA approved institutional EC.

Thai FDA Requirements

As per TFDA-ClinDrugReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, and Additional Resource (A), sponsors must submit one (1) original set and two (2) copies of the following documents to the Thai FDA:

  • Cover letter
  • Checklists and Attached Documents for Application Import License of Medicinal Drugs into Thailand for Clinical Trial according to Health Product Classification (NorYorMor1) application form (Additional Resource (B))
  • Health Product Classification (NorYorMor1) application form (Additional Resource (B))
  • Drug labels for every container (Thai or English)
  • Prescriptions (for registered drugs)
  • Investigator’s Brochure (for unregistered drugs)
  • Information Consent Certificate (Thai)
  • Patient Information Sheet (Thai)
  • Protocol synopsis (Thai)
  • Completed version of study protocol (Thai or English)
  • Chemistry, manufacturing, and control (CMC) information
  • EC approval from the ethical review committee and/or an institutionally-based EC (If not available, per TFDA-ClinDrugReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugLicenseReqs, and TFDA-ClinDrugImprt2017, it must be submitted no later than 15 days after receiving the decision)
  • Estimates of the amount of study drug, comparators, or other goods to be imported
  • Certificate of Analysis
  • Certificate of Free Sale (English and other language used)
  • Drug registration authorization document
  • Summary of product characteristics
  • Literature review
  • Description (name and content) and pictures of lab/materials to be imported
  • Power of attorney
  • Investigational medicinal product (IMP) information

EC Requirements

Additional Resource (C) represents the Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC) requirements; the MOPH ERC is one (1) of the institutions recognized by the Thai FDA.

Per Additional Resource (C), the MOPH ERC requires investigators (applicants) to submit the following documentation for ethics approval:

  • One (1) original set and 20 copies in Thai of the protocol, and one (1) copy in English for review
  • Ethical considerations
  • Combined information sheet and informed consent certificate for research participants
  • Budget details and funding source
  • Curriculum Vitae (CV) for each research team member
  • Letter of approval from implementing institution
  • Result of ethical review by EC of implementing institution, if available
  • Data collection/questionnaire tools
  • Letter signed by principal investigator’s (PI’s) supervisor
  • For an international project, Thai and foreign PI required for each side
  • Material transfer agreement for transfer of blood or biomedical samples
  • References

Refer to Additional Resource (C) for detailed MOPH ERC submission requirements.

Per G-ResEthics, each EC should establish its own requirements for protocol submission along with the required documents including the application, number of research protocol copies to be submitted, the patient information sheet, the informed consent form, and the case report form. Each EC should also communicate to personnel or staff within the institution.

Clinical Protocol

As delineated in TFDA-ClinDrugReqs and G-ResEthics, the clinical protocol should include the following elements:

  • Protocol summary
  • General information (e.g., sponsor and investigator(s) name(s) and address(es))
  • Background information (e.g., investigational product name and description)
  • Trial objectives and purpose
  • Trial design
  • Number of trial participants
  • Participant selection/withdrawal criteria
  • Participant treatment
  • Safety and efficacy assessments
  • Quality control/quality assurance
  • Adverse event reporting requirements (See Clinical Trial Lifecycle topic, Safety Reporting subtopic for additional information)
  • Statistics and methods to track trial data
  • Sponsor specifications for direct access to source data/documents
  • Ethical considerations
  • Data management and recordkeeping
  • Financing and insurance details
  • Publication policy
  • Information about each research facility in Thailand
  • Number of institutions participating in the research in Thailand
  • Other countries where the research project is being conducted
  • Investigational medicinal products (IMPs) to be used

For complete protocol requirements, refer to TFDA-ClinDrugReqs, Annex 6 of G-ResEthics, which is directly based upon the Thai-ICH-GCPs, and the ICH Harmonised Tripartite Guideline - Structure and Content of Clinical Study Reports (E3), which is also referenced in G-ResEthics.

In the instance of a multicenter clinical trial, G-ResEthics indicates that protocols submitted to each institutional EC should contain the same content substance and details, and should specify the quality control techniques to ensure that the research practices are the same in each institution.

Also, refer to Additional Resource (C) for detailed MOPH ERC submission requirements related to the protocol.

Additional Resources
Thai Food and Drug Administration, Ministry of Public Health
Thai Food and Drug Administration, Ministry of Public Health
(C) (ERC Guidelines) Guidelines and Procedures for Conducting Research on Human Subjects (Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Guidelines for the preparation of a research proposal submitted to the Ethical Review Committee for Research on Human Subjects, Ministry of Public Health (p.67); Ethical Criteria: The Ethical Review Committee for Research in Human Subjects (Revised 2007) (p. 72)
(D) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 6
(E) (ICH Guidance) Structure and Content of Clinical Study Reports (E3) (Step 4 Version) (November 1995)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Clinical Trial Lifecycle > Timeline of Review
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.2-1.3, 1.10, 1.12, and Appendices 1-7, and 13
(2) (Regulation) Notification of Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(3) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
Relevant Sections: Article 2 (Clause 3)
(4) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (June 19, 2009) (Effective Date: July 9, 2009)
Ministry of Public Health
Relevant Sections: Article 1 (Clauses 2 and 3)
(5) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (August 24, 2016) (Effective Date: October 1, 2016)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1 and 4
(6) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (WHO 1) (PubGuide-ClinDrugReqs - Thai) (Effective Date: 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(7) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research Biomedical Case (1) (PubGuide-ClinBiolProdReqs - Thai) (Effective Date: 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(8) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1 and 5
(9) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(10) (Regulation) Notification of Food and Drug Administration, Subject: Period for Providing Public Services B.E. 2559 (PubServNotif) (May 13, 2016)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(11) (Regulation) Attachment for the Notification of the Food and Drug Administration, Subject: Period for Providing Public Services B.E. 2559 (PubServNotif-Attachmt) (May 13, 2016)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(12) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 6
Summary

Overview

As set forth in TFDA-ClinDrugReqs, ECReg&Proc-2018, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the Thai Food and Drug Administration (Thai FDA)’s approval of a drug importation license is dependent upon obtaining proof of ethics committee (EC) approval to conduct the clinical trial by a Thai FDA approved institutional EC. Per TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the EC approval can be submitted to the Thai FDA after the rest of the application has been submitted for review. Therefore, the Thai FDA and EC may conduct their reviews in parallel.

Thai FDA Approval

As delineated in PubServNotif, PubServNotif-Attachmt, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, and Additional Resources (A), (B), and (C), the Thai FDA’s review and approval process for drugs to be imported for clinical trials takes 20 working days upon receipt of the application. Per the PubServNotif-Attachmt and PubGuide- ClinBiolProdReqs, the Thai FDA review and approval process for biological medicines takes 60 days. Additionally, Additional Resource (C) states that the Thai FDA’s review and approval process for placebos takes three (3) days.

As indicated in TFDA-ClinDrugReqs and Additional Resources (B), (C), and (D), the Thai FDA coordinates the review of applications submitted to obtain drug import licenses for clinical trial purposes. Per Additional Resource (B), upon receipt of a drug application package, the One Stop Service & Consultation Center (OSSC) administrative officer receives and checks the application package. If complete, the officer issues an OSSC receipt number in one (1) day, and he/she forwards the package to an officer in the International Affairs and Investigational New Drug Division (IAINDD). The Division administrative officer screens the package for completeness, issues a Division receipt number, and conducts a preliminary review of the application. The officer then forwards the package to a specialist who provides a more detailed review of the contents. Following his/her review, the specialist determines whether to grant a drug license. If the specialist approves the license, the Division officer records the specialist’s decision in the data system, and, if appropriate, a drug license is issued. The entire IAINDD process takes 18 days and five (5) hours.

Additional Resource (C) indicates that the application review process for placebo import licenses is the same in the OSSC phase, but is abbreviated in the IAINDD phase. The Division specialist reviews the package for two (2) days instead of 14 days, and then forwards the application documentation to an authorized pharmacist for approval in one (1) day. The Division officer then enters the decision into the data system and, if appropriate, a placebo license is issued.

Ethics Committee Approval

The review and approval process by a Thai FDA recognized EC will vary by institution. However, according to Additional Resource (E), which provides the Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC) requirements, and Additional Resource (F), which provides more general EC requirements, the EC review and approval process can take between two (2) and three (3) months.

According to Additional Resource (E), an application submitted to the MOPH ERC is initially reviewed by at least two (2) advisors, followed by a final review by the ERC at its regular meeting. At this meeting, the advisors present a summary of the proposal to the committee along with their recommendations. The committee discusses the proposal, and sends a list of comments to the principal investigator (PI) for clarification. Once the PI provides the requested information, the committee makes a final decision and this is reported to the MOPH ERC Chairman and the Permanent Secretary for Public Health respectively. A letter of notification signed by the Permanent Secretary for Public Health is then forwarded to the PI and the responsible organization. As earlier stated, this review and approval process is specific to the MOPH ERC. However, it can be used to obtain a better understanding of the EC process within Thailand.

Per G-ResEthics, each EC should establish its own requirements for protocol submission and timeline of review.

Additional Resources
(A) (Website) Thai FDA - One Stop Service & Consultation Center (English and Thai) (Current as of August 27, 2019)
Thai Food and Drug Administration, Ministry of Public Health
Thai Food and Drug Administration, Ministry of Public Health
Thai Food and Drug Administration, Ministry of Public Health
Thai Food and Drug Administration, Ministry of Public Health
(E) (ERC Guidelines) Guidelines and Procedures for Conducting Research on Human Subjects (Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Instruction for the Submission of a Study/Research Proposal to be Reviewed by The Ethic Review Committee for Research in Human Subject, Ministry of Public Health (p.63); Guidelines for the preparation of a research proposal submitted to the Ethical Review Committee for Research on Human Subjects, Ministry of Public Health (p.67)
Practical Law
Relevant Sections: Clinical Trials
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Clinical Trial Lifecycle > Trial Initiation
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 1.2-1.3, 1.10, 1.12, and Appendices 1-7, 11, and 13
(2) (Regulation) Notification of Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4-5 and 9-10
(3) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
Relevant Sections: Article 2 (Clause 3)
(4) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (June 19, 2009) (Effective Date: July 9, 2009)
Ministry of Public Health
Relevant Sections: Article 1 (Clauses 2 and 3)
(5) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (August 24, 2016) (Effective Date: October 1, 2016)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(6) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (WHO 1) (PubGuide-ClinDrugReqs - Thai) (Effective Date: 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(7) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research Biomedical Case (1) (PubGuide-ClinBiolProdReqs - Thai) (Effective Date: 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(8) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 3-4, and 6
(9) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Announcement (1); Notice: Preface and 2-5
(10) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct – Thai) (Last Amended April 16, 2019) (Effective Date: October 13, 2019)
National Assembly
Relevant Sections: Section 4, Chapter I (10), Chapter II (12), and Chapter V (46)
(11) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (6)
(12) (Guidance) Guidance for Adverse Event Report from “Achieving Guidance in Clinical Trial Safety Information Among Stakeholder” Forum for Ethical Review Committee in Thailand (FERCIT) (G-AEReptReqs - Thai and English) (June 2011)
Forum for Ethical Review Committees in Thailand
Relevant Sections: Descriptions and Definitions
(13) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.25, 2.8, 4.1, and 5.1
Summary

Overview

In accordance with TFDA-ClinDrugReqs, ECReg&Proc-2018, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, a clinical trial can only commence after a sponsor receives approval of a drug import application from the Thai Food and Drug Administration (Thai FDA) and approval to conduct the clinical trial from a Thai FDA recognized institutional ethics committee (EC). No waiting period is required following the sponsor’s receipt of these approvals. See the Ethics Committee topic, Ethics Committee subtopic for detailed institutional EC requirements.

According to TFDA-ClinDrugReqs, ECReg&Proc-2018, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017, and the DrugAct, the Thai FDA’s approval of a drug import license application for clinical trial purposes also serves as an import license that allows the sponsor to import investigational drugs into Thailand. According to TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the import license will expire in four (4) years from the date of issuance. TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017 further note that if the study is still ongoing after the expiry date or the amount of drug is insufficient, the sponsor can resubmit the application. (See the Investigational Products topic, Manufacturing & Import subtopic for additional information).

G-ResEthics and Additional Resource (A) specify that all investigators must also possess appropriate qualifications, training, and experience. Additionally, the clinical trial should be conducted in compliance with the Thai-ICH-GCPs.

See Additional Resource (B) for requirements specifically related to studies approved by the Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC).

Clinical Trial Agreement

G-ResEthics and the Thai-ICH-GCPs require the sponsor to sign a letter of agreement with the participating institution(s) before the trial begins. The Thai-ICH-GCPs also notes that any agreements between the sponsor and the investigator(s)/institution(s) and any other parties involved with the trial should be in writing either as part of the protocol or in a separate agreement.

EC Confirmation of Review and Approval

As per TFDA-ClinDrugReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017 and ECReg&Proc-2018, clinical trials require institutional level EC approval for each trial site from an EC recognized by the Thai FDA. As delineated in ECReg&Proc-2018, Thai FDA recognized ECs are responsible for reviewing and approving clinical research involving drugs to be imported for use in Thailand. (See Ethics Committee topic, Scope of Review subtopic for additional details on the EC review process).

Thailand Clinical Trials Registry

The TFDA-ClinDrugReqs application document checklist (Appendix 3) includes clinical trial registry information as one (1) of the items to be included in the application submission package. The summary of research project requirements (Appendix 7) in TFDA-ClinDrugReqs also specifies that sponsors may register with either the Thai Clinical Trials Registry (TCTR) (Additional Resource (D)) or a foreign registry. Sponsors may register in more than one (1) location.

Data and Safety Monitoring Board

Although G-AEReptReqs and the G-ResEthics do not mandate establishing a Data Safety Monitoring Board (DSMB), it is encouraged. Per the Thai-ICH-GCPs, a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Additional Resources
Practical Law
Relevant Sections: Clinical Trials
(B) (ERC Guidelines) Guidelines and Procedures for Conducting Research on Human Subjects (Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Ethical Criteria: The Ethical Review Committee for Research in Human Subjects (p. 72)
(C) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 2.8, 4.1, and 5.1
(D) (Website) Thai Clinical Trials Registry (TCTR) (Current as of August 27, 2019)
Medical Research Network (MedResNet), Medical Research Foundation
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Clinical Trial Lifecycle > Safety Reporting
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4.5 and Appendix 20
(2) (Guidance) Guidance for Adverse Event Report from “Achieving Guidance in Clinical Trial Safety Information Among Stakeholder” Forum for Ethical Review Committee in Thailand (FERCIT) (G-AEReptReqs - Thai and English) (June 2011)
Forum for Ethical Review Committees in Thailand
Relevant Sections: Descriptions and Definitions, 1, 2, 4, Appendix 1, Appendix 2, Appendix 3, and Appendix 4
(3) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.1-1.2, 1.50, 1.60, and 5.17
(4) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (May 28, 2018) (Effective Date: September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3
(5) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 2
(6) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3.3
(7) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (17)
Summary

Overview

In accordance with TFDA-ClinDrugReqs, G-AEReptReqs, and the Thai-ICH-GCPs, the following definitions provide a basis for a common understanding of Thailand’s safety reporting requirements:

  • Adverse Event (AE) – Any untoward or unfavorable medical occurrence in a research participant to whom a drug product was administered, and which does not necessarily bear a causal relationship to the treatment
  • Adverse Drug Reaction (ADR) – All noxious and unintended responses to a medicinal product related to any dose
  • Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
  • Suspected Unexpected Serious Adverse Reaction (SUSAR) – An unexpected SAE/SADR given the nature of the research procedures and the population being studied (Note: this definition is found in the G-AEReptReqs)
  • Unexpected Adverse Event/Adverse Drug Reaction – A reaction where the nature or severity is inconsistent with the applicable product information

The Thai-ICH-GCPs also notes that the ICH Harmonised Tripartite Guideline - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) should be referenced for additional safety terms not defined in this list.

Reporting Requirements for AEs/ADRs

As delineated in TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017, and the Thai-ICH-GCPs, sponsors who are permitted to import or order drugs into Thailand for research and those who are licensed to produce drugs, must comply with the Thai Food and Drug Administration (Thai FDA)’s safety monitoring and reporting requirements. TFDA-ClinDrugReqs states that the following information is viewed as urgent and is required to be reported:

  • SAEs/SADRs that never occurred before because the research team used safety reporting information from other countries to substantiate investigational product (IP) use
  • Other safety and security information useful to evaluating IP risks, IP changes, or changes required in trial operations as a whole
  • SAE/SADR incidents that never occurred before, or, with the level of severity
  • Participants harmed by IPs used to treat life-threatening conditions who have experienced no significant benefits
  • Significant new information about experimental animal safety studies

Per TFDA-ClinDrugReqs, an ADR report must be filed in the following specified timelines:

  • Unexpected SAEs/SADRs that are fatal or life-threatening must be reported to the Thai FDA within six (6) days from the first knowledge of the incident’s occurrence. Any additional relevant information should be sent within seven (7) days of the initial report
  • Unexpected SAEs/SADRs that are not fatal or life-threatening must be reported to the Thai FDA within 15 days from the date of SAE/SADR notification. A report must also be submitted periodically with any additional information. Refer to Additional Resource (B) for the Thailand Health Product Adverse Event Report Form
  • AEs/ADRs that occur following the research participant’s participation in the study or after the study has been completed must be reported within 15 days from first knowledge of the event

Furthermore, per TFDA-ClinDrugReqs, annual and end of study safety reports must be provided to the Thai FDA’s Bureau of Drug Control. The annual report must be submitted within three (3) months of the one (1) year anniversary of the study, and the final safety report must be provided within six (6) months after the study has concluded. In addition, a list of all SAE/SADR incidents involving research participant(s) should also be included in the annual report. A detailed summary table with the number of SAEs/SADRs organized by terminology (symptoms and diagnosis) should be provided. See Appendix 20 in TFDA-ClinDrugReqs for an example of the reporting form.

Investigator Responsibilities

As stated in G-AEReptReqs, the PI is responsible for reporting all SAEs/SADRs to the sponsor and the ethics committee (EC) no later than 24 hours after the PI becomes aware of the event. The PI must also report all AEs/ADRs to the sponsor and the EC no later than seven (7) calendar days following first knowledge.

For safety reporting requirements specific to the Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC), please see Additional Resource (C).

Sponsor Responsibilities

According to G-AEReptReqs and G-ResEthics, the sponsor is also required to report all SUSARs to the EC as soon as possible, but no later than seven (7) calendar days for all fatal or life-threatening events, and no later than 15 calendar days for any non-fatal or non-life-threatening events. The sponsor must include his/her main points of concern. In addition, the sponsor must report to the EC any other non-local adverse reactions that may increase risks to participants within 15 days. Additionally, the sponsor must report any non-local SAEs/SADRs including SUSARs at least every six (6) months to the EC.

G-ResEthics and the Thai-ICH-GCPs state that the sponsor is responsible for expediting the reporting of all SUSARs to the investigator(s)/institution(s) participating in the trial, the EC(s), and to the Thai FDA. These reports should comply with G-AEReptReqs and the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A). See G-AEReptReqs for detailed reporting requirements for the investigator and sponsor.

The Thai-ICH-GCPs also indicates that the sponsor should submit to the Thai FDA all safety updates and periodic reports as required by applicable regulatory requirements. The sponsor is also responsible for the ongoing safety evaluation of investigational drug(s) and should promptly notify all concerned parties of findings that could adversely impact the safety of research participants, the conduct of the trial, or, alter the EC’s approval or favorable opinion to continue the trial.

Form Completion & Delivery Requirements

As per G-AEReptReqs, all SAEs/SADRs and SUSARs must be reported on the Thai FDA’s Health Product Vigilance Center (HPVC) SAE reporting form (Additional Resource (D)) or the Council for International Organizations of Medical Sciences’ (CIOMS’) form (Additional Resource (E)). According to Additional Resources (D) and (F), AEs/ADRs and SAEs/SADRs must be reported to the Thai FDA. Additional Resource (D) indicates that the SAE form should be sent to the HPVC via mail, fax, or email at:

Mailing Address:

Healthcare Product Safety Surveillance Center
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanond Road
Nonthaburi 11000
Thailand

Fax: 02­5907253 or 02­5918457
Email: adr@fda.moph.go.th

Pursuant to TFDA-ClinDrugReqs, individual reports should be submitted electronically via the Thai FDA’s HPVC’s Healthcare Product Surveillance System, unless the system is unavailable. Individual report data should include at minimum the following information:

  • Research participant information for those that can be identified (e.g., participant codes)
  • Investigational drugs used in research study
  • AE/ADR symptoms or results suspected of being connected to the drugs
  • Source of follow-up reports
  • Research project code or name
  • Reporting numbers (e.g., report number specified by sponsor)

For research studies involving participants whose identities are disclosed, submitted AE/ADR reports should include the participant codes unless the Thai FDA’s Office of the Board of Directors deems it necessary to reveal the code immediately.

Data Safety Monitoring Board

Although G-ResEthics and G-AEReptReqs do not appear to mandate establishing a Data Safety Monitoring Board (DSMB), it is encouraged. Per the Thai-ICH-GCPs, a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Additional Resources
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.1-1.2., 1.50, 1.60, and 5.17
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: II
(C) (ERC Guidelines) Guidelines and Procedures for Conducting Research on Human Subjects (Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Ethical Criteria: The Ethical Review Committee for Research in Human Subjects (Revised 2007) (p. 72); Additional Resolution of the Committee (2005) (p. 76)
Health Product Vigilance Center (HPVC), Food and Drug Administration, Ministry of Public Health
(E) (Form) CIOMS Form I (Date unavailable)
Council for International Organizations of Medical Sciences
(F) (Form) Additional investigation Guidelines (HPVC Form – 13) (Thai) (Date Unavailable)
Health Product Vigilance Center (HPVC), Food and Drug Administration, Ministry of Public Health
Health Product Vigilance Center (HPVC), Food and Drug Administration, Ministry of Public Health
(H) (Website) Health Product Vigilance Center (HPVC) (Thai) (Current as of August 27, 2019)
Health Product Vigilance Center (HPVC), Food and Drug Administration, Ministry of Public Health
Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program and US Agency for International Development (USAID)
Relevant Sections: Signal Generation and Data Management – Existence of a Form for Reporting Suspected ADRs, and Annex F and G
Clinical Trial Lifecycle > Progress Reporting
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 6.6
(2) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4.10
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4.1, 4.3 and Appendices 14-15 and 19
(4) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (August 24, 2016) (Effective Date: October 1, 2016)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3
(5) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3
(6) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3.3
Summary

Overview

Pursuant to G-ResEthics, the investigator(s) is responsible for submitting progress reports on the status of the trial and for submitting a final study report to the ethics committee (EC). The Thai-ICH-GCPs also indicates that investigator(s) should submit progress reports to the EC. TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017 state that the sponsor is required to submit annual progress reports to the Thai Food and Drug Administration (Thai FDA).

Interim/Progress Reports

As delineated in G-ResEthics, the investigator(s) must submit progress reports to the EC at the designated interval (not specified). For high-risk research protocols, investigator(s) should report the progress more frequently than for a low-risk protocol. The investigator should also propose to the EC how often he/she plans to submit a progress report from the date of protocol submission for ethical review, and this should be at least once a year.

The Thai-ICH-GCPs further notes that investigator(s) should submit a summary report of the research in writing to the EC once a year, or, more often, as required by the EC. Investigator(s) should send a written report to the EC and the institution, if applicable, regarding any changes that may impact the research process and/or cause increased risk to the research participants.

In addition, according to TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the sponsor must submit a study progress report annually to the Thai FDA between October 1 and 31 every year until the study ends. Per TFDA-ClinDrugReqs, this report should be submitted using the progress report form in Appendix 15, and accompanied by a delivery letter to the Thai FDA’s Director of the Bureau of Medicine using the format in Appendix 14.

Final Report

As specified in TFDA-ClinDrugReqs and TFDA-ClinDrugImprt2017, in the event of early termination of the research study, the sponsor must submit a summary report (Appendix 19 of TFDA-ClinDrugReqs) to the Thai FDA within 60 days after the close-out of the last study site.

G-ResEthics also requires investigator(s) to submit a final report to the EC upon the trial’s termination.

For reporting requirements specific to the Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC), please see Additional Resource (B). The MOPH ERC is one of the Thai FDA approved ECs to review and approve clinical trial protocols.

Per an in-country subject matter expert, because each EC has its own requirements, it is recommended that the individual ECs be contacted to confirm their specific requirements.

Additional Resources
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.10
(B) (ERC Guidelines) Guidelines and Procedures for Conducting Research on Human Subjects (Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Ethical Review Committee for Research in Human Subjects Ministry of Public Health (Revised 2007) (p. 72); Additional Resolution of the Committee (2005) (p. 76); Additional Resolution of the Committee (2006) (p. 80)
Sponsorship > Definition of Sponsor
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5
(2) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.20, 1.53-1.54, and 5.2
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Appendices 1, 3, and 7-8
Summary

Overview

As specified in G-ResEthics, the Thai government complies with the Thai-ICH-GCPs, which defines a sponsor as an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.

Per G-ResEthics and the Thai-ICH-GCPs, the Thai government also permits a sponsor to authorize a contract research organization (CRO) to perform one (1) or more of a sponsor’s trial-related duties and functions. However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities to be transferred and assumed by a CRO should be specified in a written agreement or contract. A sponsor may be domestic or foreign. The Thai-ICH-GCPs also states that the sponsor may be a sponsor-investigator if he/she both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered or dispensed. The sponsor-investigator’s obligations include both those of a sponsor and those of an investigator.

According to Additional Resource (B), the Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC), which is one (1) of the ethics committees  approved by the Thai Food and Drug Administration (Thai FDA) to approve clinical research protocols, requires that the sponsor and/or CRO be legally registered in Thailand. See Additional Resource (B) for more details.

Per TFDA-ClinDrugReqs, the sponsor is also referred to as the applicant or importer.

Additional Resources
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.20, 1.53-1.54, and 5.2
(B) (ERC Guidelines) Guidelines and Procedures for Conducting Research on Human Subjects (Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Additional Resolution of the Committee (2005) (p. 76) and Additional Resolution of the Committee (2006) (p. 80)
Sponsorship > Trial Authorization
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 1.1-1.4, 1.10, 1.12, and Appendices 1-4 and 13
(2) (Regulation) Notification of Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4-5
(3) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
Relevant Sections: Article 2 (Clause 3)
(4) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (June 19, 2009) (Effective Date: July 9, 2009)
Ministry of Public Health
Relevant Sections: Article 1 (Clauses 2 and 3)
(5) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (May 28, 2018) (Effective Date: September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3-5
(6) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (WHO 1) (PubGuide-ClinDrugReqs - Thai) (Effective Date: 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(7) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research Biomedical Case (1) (PubGuide-ClinBiolProdReqs - Thai) (Effective Date: 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(8) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface and 3-4
(9) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Notice: Preface, 2-3, and 5
(10) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct – Thai) (Last Amended April 16, 2019) (Effective Date: October 13, 2019)
National Assembly
Relevant Sections: Section 4, Chapter I (10), Chapter II (12), and Chapter V (46)
Summary

Overview

In accordance with TFDA-ClinDrugReqs, ECReg&Proc-2018, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the sponsor or his/her contract research organization (CRO) is responsible for submitting a drug import license application to the Thai Food and Drug Administration (Thai FDA). As per the DrugAct, TFDA-ClinDrugReqs, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, and TFDA-ClinDrugImprt2017, the Thai FDA is the authority responsible for controlling the import of drugs for research purposes, and also uses this authority to indirectly regulate drug clinical trials in humans. Per TFDA-ClinDrugReqs, the sponsor is also referred to as the applicant or importer.

To complete the application package, the sponsor or his/her CRO must use the Thai FDA’s Health Product Classification application form (also referred to as the NorYorMor1 application form (see Additional Resource (A)). In addition to the completed application, the sponsor or the CRO must also provide the ethics committee (EC) approval letter, clinical protocol, participant information sheet, informed consent certificate, a certificate of analysis, and other documentation covered in the Clinical Trial Lifecycle topic, Submission Content subtopic.

Additional Resources
Thai Food and Drug Administration, Ministry of Public Health
Practical Law
Relevant Sections: Clinical Trials
Sponsorship > Insurance
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.10 and Appendices 3 and 7
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (8)
Summary

Overview

TFDA-ClinDrugReqs specifies that financing and insurance information should be included in the study protocol and protocol synopsis. If not included in the protocol and research project summary, a financial/insurance agreement should be attached separately in the application package as one (1) of the documents that the ethics committee (EC) considers approved or certified. G-ResEthics also states that the sponsor should provide insurance or indemnify the investigator/institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence, if required by applicable regulatory requirements.

See the Sponsorship topic, Compensation subtopic and Informed Consent topic, Compensation Disclosure subtopic for specific details related to sponsorship compensation obligations.

Additional Resources
No additional resources
Sponsorship > Compensation
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.8 and Appendices 3
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 3.2 and Annex 5 (8)
(3) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4.8 and Annex 5 (8)
Summary

Overview

As specified in TFDA-ClinDrugReqs, G-ResEthics, and the Thai-ICH-GCPs, the sponsor or his/her designated contract research organization (CRO) is responsible for providing information related to compensation in the event of trial-related injuries or death to research participants and/or their legal heirs. The sponsor must also inform the participants of any available medical treatment in the event of trial-related injuries.

As per G-ResEthics, Phase I trial participants should be compensated for travel, loss of work, or other expenses incurred while participating in the trial.

Additional Resources
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8 and Annex 5 (8)
Sponsorship > Quality, Data & Records Management
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.7, 1.10, 4.3-4.4, 4.6, and Appendix 19
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (1, 5, 6, 19, 21, and 23)
(3) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4.9, 4.12, 5.1, 5.5, 5.19, and 5.23
(4) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (May 28, 2018) (Effective Date: September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3
(5) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3
(6) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Notice: 3
Summary

Overview

As stated in TFDA-ClinDrugReqs and G-ResEthics, the sponsor is responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol and the Thai-ICH-GCPs. The sponsor is required to obtain agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed.

TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017 state that the trial must be conducted in accordance with the Good Clinical Practice (GCP) and Good Laboratory Practice principles (GLP).

The sponsor must also obtain the investigator(s) and the institution(s) agreement to:

  • conduct the trial in compliance with the Thai-ICH-GCPs, applicable regulatory requirement(s), and the protocol agreed to by the sponsor and approved by the ethics committee (EC)
  • comply with data recording and reporting procedures
  • permit monitoring, auditing, and inspection
  • retain essential documents until the sponsor informs them that they are no longer needed

Electronic Data Processing System

Per G-ResEthics and the Thai-ICH-GCPs, when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance, and that he/she maintains SOPs for using these systems. Refer to G-ResEthics and the Thai-ICH-GCPs for detailed information on electronic trial data systems. TFDA-ClinDrugReqs also notes that sponsors should ensure that research facilities are prepared for inspections by the Thai Food and Drug Administration (Thai FDA) by ensuring that research participant source data and case report forms are stored in electronically based data collection systems.

Record Management

As set forth in G-ResEthics and the Thai-ICH-GCPs, sponsor-specific essential documents should be retained until at least two (2) years after the last approval of a marketing application in an ICH region, until there are no pending or contemplated marketing applications, or at least two (2) years have elapsed since the formal discontinuation of an investigational product’s clinical development. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

Audit Requirements

As part of its QA system, G-ResEthics and the Thai-ICH-GCPs note that the sponsor may choose to perform a clinical trial audit. The purpose of the audit should be to evaluate trial conduct and compliance with the protocol, SOPs, and other applicable regulatory requirements. The sponsor should ensure that the auditors are qualified by training and experience, and the auditor’s qualifications should be documented. The sponsor must also ensure that the audit is conducted in accordance with his/her own SOPs, the auditor observations are documented, and data are available as needed for the Thai FDA. No specific timeframe is provided for the audit process.

Per TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the sponsor and investigator must facilitate the Thai FDA’s monitoring of the clinical trial to ensure compliance with GCP and GLP, safety reporting, and progress reporting requirements.

Premature Study Termination/Suspension

G-ResEthics and the Thai-ICH-GCPs state that if the sponsor chooses, or is required to terminate a study, the investigator(s) should promptly inform the institution, and the investigator or institution should also immediately inform the EC and provide a detailed explanation of the termination or suspension. TFDA-ClinDrugReqs also specifies that the Thai FDA must be notified no later than 30 working days after the date of discontinuance.

As stated in TFDA-ClinDrugReqs and TFDA-ClinDrugImprt2017, at the conclusion or termination of a clinical trial, a summary report must also be submitted within 60 days after the close-out of the last study site (Appendix 19 in TFDA-ClinDrugReqs contains a sample notification form required to be completed when terminating a research project).

Multicenter Studies

As delineated in G-ResEthics and the Thai-ICH-GCPs, in the event of a multicenter clinical trial, the sponsor must ensure that:

  • All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and, if required, by the Thai FDA, and given EC approval
  • The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
  • Investigator responsibilities are documented prior to the start of the trial
  • All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs
  • Communication between investigators is facilitated
Additional Resources
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.9, 4.12, 5.1, 5.5, 5.19, and 5.23
Thai Food and Drug Administration, Ministry of Public Health
Sponsorship > Site/Investigator Selection
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (5, 6 and 7)
(2) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.25, 4.1, 5.1, and 5.7
(3) (Guidance) Guidance for Adverse Event Report from “Achieving Guidance in Clinical Trial Safety Information Among Stakeholder” Forum for Ethical Review Committee in Thailand (FERCIT) (G-AEReptReqs - Thai and English) (June 2011)
Forum for Ethical Review Committees in Thailand
Relevant Sections: Descriptions and Definitions, Appendix 3
Summary

Overview

G-ResEthics, which implements the Thai-ICH-GCPs, states that the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial, and for ensuring that the investigator(s) are qualified by training and experience. Additionally, the sponsor must define and allocate all study related duties and responsibilities to the relevant parties participating in the study. As delineated in the Thai-ICH-GCPs and G-ResEthics, prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor should provide the investigator(s) with the protocol and an investigator’s brochure.

Data Safety Monitoring Board

Although not specified as a sponsor requirement, G-ResEthics, G-AEReptReqs, and the Thai-ICH-GCPs seem to encourage the establishment of a Data Safety Monitoring Board (DSMB).

Additional Resources
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 4.1, 5.1, and 5.7
Informed Consent > Documentation Requirements
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.8 and Appendix 3
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 2.2, 3.1, 3.2, and 3.3
(3) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.27-1.28, 2.9, 3.1, 4.8, and 8.2-8.3
(4) (Legislation) National Health Act B.E. 2550 (NatHlthAct – English, unofficial translation) (Thai) (March 3, 2007)
National Assembly
Relevant Sections: Section 9
Summary

Overview

In all Thai clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in TFDA-ClinDrugReqs, G-ResEthics, and the Thai-ICH-GCPs. As per TFDA-ClinDrugReqs, G-ResEthics, and the Thai-ICH-GCPs, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an institutional ethics committee (EC) recognized by the Thai Food and Drug Administration (Thai FDA), and provided to the Thai FDA with the drug import permit application to conduct a clinical trial. (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

TFDA-ClinDrugReqs, the Thai-ICH-GCPs, the NatHlthAct, and G-ResEthics state that the investigator(s) or his/her representative(s) must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). G-ResEthics and the Thai-ICH-GCPs also specify that the oral and written information concerning the trial, including the ICF, should be easy to understand and presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. The participant, and his/her legal representative(s) or guardian(s), should also be given adequate time to consider whether to participate.

Additional Resource (A) provides informed consent documentation guidelines required by the Ministry of Public Health (MOPH)'s Ethical Review Committee for Research in Human Subjects (ERC), which is one (1) of the institutional ECs approved by the Thai FDA.

Language Requirements

As stated in TFDA-ClinDrugReqs, the ICF content and accompanying information (Patient Information Sheet) should be presented in the participant’s language and must be submitted in Thai and translated to English.

Documentation Copies

G-ResEthics and the Thai-ICH-GCPs state that the participant and/or the participant’s legal representative(s) or guardian(s), and the investigator(s) must sign and date the ICF. Where the participant is illiterate, and/or his/her legal representative(s) or guardian(s) is illiterate, verbal consent should be obtained in the presence of and countersigned by an impartial witness. The NatHlthAct also indicates that the participant’s consent must be obtained in writing prior to conducting the trial.

Additional Resources
(A) (ERC Guidelines) Guidelines and Procedures for Conducting Research on Human Subjects (Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Information Sheet (p.70)
(B) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.27-1.28, 2.9, 3.1, 4.8, and 8.2-8.3
(C) (WMA Guidance) Declaration of Helsinki (Thai) (October 19, 2013)
World Medical Association
(D) (Document) Nuremberg Code (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Council for International Organizations of Medical Sciences (CIOMS)
Nuffield Council on Bioethics
Informed Consent > Required Elements
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.8 and Appendix 3
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 3.1.1 and 3.2
(3) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.27, 2.6, 3.1, 4.8, and 8.2-8.3
Summary

Overview

As delineated in TFDA-ClinDrugReqs and G-ResEthics, prior to beginning a clinical trial, the sponsor or his/her contract research organization (CRO) is required to obtain ethics committee (EC) approval from the Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC) and/or the institutional ECs for the written informed consent form (ICF) and any other information being provided to the research participant and/or his/her legal representative(s) or guardian(s). The Thai-ICH-GCPs also indicates that the ICF and other consent related documentation must be approved by the institutional EC.

No Coercion

As per G-ResEthics and the Thai-ICH-GCPs, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant and/or his/her legal representative(s) and/or guardian(s) to waive or to appear to waive his/her legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence.

ICF Required Elements

Based on TFDA-ClinDrugReqs, G-ResEthics, and the Thai-ICH-GCPs, the ICF should include the following statements or descriptions, as applicable:

  • The study purpose, procedures, and duration
  • Experimental aspects of the study
  • The participant’s responsibilities in participating in the trial
  • Any expected risks or discomforts to the participant, and when applicable, to an embryo, fetus, or nursing infant
  • Disclosure of alternate procedures or treatments available to participants
  • Clinical trial treatment schedule(s) and the probability for random assignment to each treatment
  • The disclosure of specific appropriate alternative procedures or therapies available to the participant
  • Any benefits or prorated payment to the participant or others reasonably expected from the research; if no benefit is expected, the participant should be made aware of this
  • Compensation and/or treatment available for the participant in the case of trial-related injury
  • That participation is voluntary, and that the participant can withdraw from the study at any time without penalty or loss of benefits, including medical treatment, to which the participant is otherwise entitled
  • The extent to which confidentiality of records identifying the participant will be maintained, and the possibility of record access by the Thai Food and Drug Administration (Thai FDA), the ECs, the auditor(s), and the monitor(s)
  • That the participant and/or his/her legal representative(s) or guardian(s) will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue
  • Individuals to contact for further information regarding the trial, the rights of trial participants, and whom to contact in the event of trial-related injury
  • Foreseeable circumstances under which the investigator(s) may remove the participant without his/her consent
  • The consequences of a participant’s decision to withdraw from the research, and procedures for orderly withdrawal by the participant
  • Any additional costs to the participant that may result from participation in the research

Additional Resource (A) provides information sheet guidelines required by the MOPH ERC, which is one (1) of the institutional ECs approved by the Thai FDA.

See the Informed Consent topic, Compensation Disclosure subtopic and Vulnerable Populations subtopic and the Specimens topic, Consent for Specimens subtopic for further information.

Additional Resources
(A) (ERC Guidelines) Guidelines and Procedures for Conducting Research on Human Subjects (Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Information Sheet (p.70)
(B) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.27, 2.6, 3.1, 4.8, and 8.2-8.3
(C) (WMA Guidance) Declaration of Helsinki (Thai) (October 19, 2013)
World Medical Association
(D) (Document) Nuremberg Code (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Council for International Organizations of Medical Sciences (CIOMS)
Nuffield Council on Bioethics
Informed Consent > Compensation Disclosure
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.8 and Appendix 3
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 3.1.1, 3.1.2, and Annex 5 (8)
(3) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4.8
Summary

Overview

In accordance with TFDA-ClinDrugReqs, G-ResEthics, and the Thai-ICH-GCPs, the informed consent form (ICF) should contain a statement describing the compensation or medical treatment a participant can receive for participating in a clinical trial. (See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF, and the Sponsorship topic, Compensation subtopic for information on sponsor requirements.)

Compensation for Participation in Research

TFDA-ClinDrugReqs states that participants should be informed of compensation (if any) to be provided for participating in the research. As per G-ResEthics, Phase I trial participants should be compensated for travel, loss of work, or other expenses incurred while participating in the trial. In addition, as specified in the G-ResEthics and the Thai-ICH-GCPs, the ICF should also inform all trial participants of any types of expenses that they may incur as a result of participation. The Thai-ICH-GCPs also indicates that the ICF should state if any compensation will be provided for participants involved in the research study.

Compensation for Injury

As stated in TFDA-ClinDrugReqs, G-ResEthics, and the Thai-ICH-GCPs, the ICF should contain a statement advising the participant and describing the compensation and medical treatment available in the event of any trial-related injury in a clinical trial.

Additional Resources
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
(B) (WMA Guidance) Declaration of Helsinki (Thai) (October 19, 2013)
World Medical Association
(C) (Document) Nuremberg Code (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Council for International Organizations of Medical Sciences (CIOMS)
Nuffield Council on Bioethics
Informed Consent > Participant Rights
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 2.2, 3.1, 3.2, 3.3, and 4.1
(2) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.28, 4.8, and 8.2
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.8 and Appendix 3
(4) (Legislation) National Health Act B.E. 2550 (NatHlthAct – English, unofficial translation) (Thai) (March 3, 2007)
National Assembly
Relevant Sections: Section 9
Summary

Overview

In accordance with G-ResEthics, and the Thai-ICH-GCPs, Thailand’s ethical standards promote respect for all human beings and safeguard the rights of research participants. TFDA-ClinDrugReqs, G-ResEthics, the Thai-ICH-GCPs, and the NatHlthAct state that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process.

The Right to Participate, Abstain, or Withdraw

As set forth in TFDA-ClinDrugReqs, G-ResEthics, and the Thai-ICH-GCPs, the participant or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, that he/she may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled. NatHlthAct also states that the participant may withdraw his/her consent at any time.

The Right to Information

As delineated in TFDA-ClinDrugReqs, G-ResEthics, the NatHlthAct, and the Thai-ICH-GCPs, a potential research participant and/or his/her legal representative(s) or guardian(s) has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study.

The Right to Privacy and Confidentiality

As per TFDA-ClinDrugReqs, G-ResEthics, and the Thai-ICH-GCPs, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

The Right of Inquiry/Appeal

TFDA-ClinDrugReqs, G-ResEthics, and the Thai-ICH-GCPs, states that the research participant and/or his/her legal representative(s) or guardian(s) should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries.

The Right to Safety and Welfare

G-ResEthics states that a research participant’s right to safety and the protection of his/her health and welfare must take precedence over the interests of science and society.

(See the Informed Consent topic, and the subtopics of Required Elements and Vulnerable Populations for additional information regarding requirements for participant rights.)

Additional Resources
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.28, 4.8, and 8.2
(B) (WMA Guidance) Declaration of Helsinki (Thai) (October 19, 2013)
World Medical Association
(C) (Document) Nuremberg Code (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Council for International Organizations of Medical Sciences (CIOMS)
Nuffield Council on Bioethics
Informed Consent > Special Circumstances/Emergencies
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.61, 3.17, and 4.8.15
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 2.2.3, 3.3, and 6.4
Summary

Overview

Per the Thai-ICH-GCPs, research participants involved in clinical research under emergency circumstances are viewed as vulnerable and should be provided additional protections to ensure their safety and well-being. G-ResEthics also makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by special circumstances.

Medical Emergencies

The Thai-ICH-GCPs explains that in an emergency, if the signed informed consent form (ICF) cannot be obtained from the research participant, the consent of his/her legal representative(s) or guardian(s) should be obtained. If prior consent cannot be obtained from the legal representative(s) or guardian(s), the participant’s enrollment should follow measures specified in the protocol, and/or elsewhere, to ensure compliance with ethics committee (EC) and other applicable regulatory requirements. Documented EC approval to protect the participant’s rights, safety, and well-being must also be obtained. The participant and/or his/her legal representative(s) or guardian(s) should be informed about the trial as soon as possible and provide consent. Consent should also continue to be obtained throughout the trial as appropriate per the Thai-ICH-GCPs.

Waiver of Consent

As per G-ResEthics, the EC should establish the conditions under which an informed consent discussion and/or signing the ICF can be waived. In these cases, the investigator must explore other means to protect the participant’s confidentiality. For example, if the investigator uses information from a participant’s medical records, he/she must ensure that the ICF is kept in the medical record by having the participant sign the form in advance and keep it in the records, or by having the participant sign the ICF later. The EC will then consider waiving the informed consent as long as the investigator provides proof that the participant is informed about the method for collecting the data, and that the participant’s privacy is protected.

Additional Resources
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.61, 3.17, and 4.8.15
(B) (WMA Guidance) Declaration of Helsinki (Thai) (October 19, 2013)
World Medical Association
(C) (Document) Nuremberg Code (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Council for International Organizations of Medical Sciences (CIOMS)
Nuffield Council on Bioethics
Informed Consent > Vulnerable Populations
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 2.2.2 and 3.4
(2) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.61
Summary

Overview

As per G-ResEthics and the Thai-ICH-GCPs, in all Thai clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. G-ResEthics characterizes vulnerable populations as those who are dependent on others, and are unable to express their opinion freely or make their own decisions. The Thai-ICH-GCPs adds that, whether reasonable or not, the participant may also consent to participate out of fear that they will be penalized for not participating. This may apply, for example, to members of a hierarchical organization such as medical, pharmacy, dental, or nursing students and lower-level hospital personnel and staff rooms. The Thai-ICH-GCPs also notes that participants in this study population may be persuaded to enter a trial with the hope of obtaining benefits from their participation in the research. Per G-ResEthics, these participants may include hospitalized patients, prisoners, children, the mentally impaired, critically ill and psychotic patients, pregnant women, and the disadvantaged. Per the Thai-ICH-GCPs, other vulnerable participants may include drug company employees, soldiers, prisoners, patients with incurable diseases, emergency patients, unemployed or poor people, members of minority groups, the homeless, immigrants, and young people who are unable to give consent on their own.

G-ResEthics specifies that trials involving vulnerable persons must meet the following requirements:

  • Irrefutable rationale for conducting research clearly explained in the protocol
  • Precautions against possible physical and mental harms exercised
  • Appropriate research procedures used
  • Ensure that, as applicable, the participant’s parents and/or his/her legal representative(s) or guardian(s) are fully informed about the study
  • Proof that the participants are voluntarily participating in the study
  • Ensure that the possible risks should not be greater than minimal when a study will not have a direct health benefit to the vulnerable group, unless the ethics committee permits a greater than minimal risk study to be conducted

See the Informed Consent topic, and the subtopics of Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired for additional information about these vulnerable populations.

Additional Resources
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.61
(B) (WMA Guidance) Declaration of Helsinki (Thai) (October 19, 2013)
World Medical Association
(C) (Document) Nuremberg Code (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Council for International Organizations of Medical Sciences (CIOMS)
Nuffield Council on Bioethics
Informed Consent > Children/Minors
Last content review/update: August 29, 2019
Requirements
(1) (Legislation) Thailand Civil and Commercial Code (B.E. 2468) (ThaiCode - English, unofficial version) (Thai) (January 1, 1925)
National Assembly
Relevant Sections: Part II (Sections 19 and 20)
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 2.2.2 and 3.4
Summary

Overview

According to the ThaiCode, a minor is someone under 20 years of age or married. As set forth in G-ResEthics, when the research participant is a minor, informed consent should be obtained from his/her parents, guardians or legal representatives. Additionally, precautions against possible physical and mental harms should be exercised. Furthermore, the rights of the minors should be respected for their voluntary decision to participate in a clinical study.

The Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC) guidelines (Additional Resource (A)) specifies that the age suitable to give consent is 18 years or older. See Additional Resource (A) for more details, as well as information regarding age of assent. The MOPH ERC is one (1) of the institutional ethics committees approved by the Thai Food and Drug Administration (Thai FDA).

Additional Resources
(A) (ERC Guidelines) Guidelines and Procedures for Conducting Research on Human Subjects (Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Additional Resolution of the Committee (2006) (p.77)
(B) (WMA Guidance) Declaration of Helsinki (Thai) (October 19, 2013)
World Medical Association
(C) (Document) Nuremberg Code (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Council for International Organizations of Medical Sciences (CIOMS)
Nuffield Council on Bioethics
Informed Consent > Pregnant Women, Fetuses & Neonates
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 2.2 and 3.4
Summary

Overview

As per G-ResEthics, any Thai clinical studies involving pregnant women and fetuses require additional safeguards to ensure that the research conforms to appropriate ethical standards and upholds societal values. Adequate information on the safety and impacts to the fetus should also be made available.

Additional Resources
(A) (WMA Guidance) Declaration of Helsinki (Thai) (October 19, 2013)
World Medical Association
(B) (Document) Nuremberg Code (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Council for International Organizations of Medical Sciences (CIOMS)
Nuffield Council on Bioethics
Informed Consent > Prisoners
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 2.2, 3.2, and 3.4
Summary

Overview

According to G-ResEthics, prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. A research study involving prisoners should ensure that these prospective participants are informed, and are given the opportunity to make their own decisions without any interference from a higher authority.

Additional Resources
(A) (WMA Guidance) Declaration of Helsinki (Thai) (October 19, 2013)
World Medical Association
(B) (Document) Nuremberg Code (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Council for International Organizations of Medical Sciences (CIOMS)
Nuffield Council on Bioethics
Informed Consent > Mentally Impaired
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 3.4.5
(2) (Legislation) Mental Health Act B.E. 2551 (MentalHlthAct – Thai) (Effective Date: February 21, 2008)
National Assembly
Relevant Sections: Sections 3, 17, and 20-22
Summary

Overview

Per G-ResEthics, informed consent should be obtained from the legal representatives or guardians of participants for studies involving psychiatric or mentally incapacitated patients.

As further explained in MentalHlthAct, any research to be conducted with patients who are mentally impaired have the right to:

  • Receive treatment according to medical standards that protect human dignity
  • Have information about their illness and treatment kept confidential other than what is required to be disclosed by law
  • Sign an ethics committee (EC) approved consent form prior to participation
  • Receive equal access to state health insurance and social security systems

In addition, MentalHlthAct prohibits disclosure of health information of mentally impaired participants in a manner that may damage the individual, except in the event that the patient or others may be in danger, for public safety, or specific laws require this information to be disclosed.

MentalHlthAct also states that any research involving patients who are mentally impaired can only be performed after obtaining their consent as well as EC approval and approval from other relevant authorities to conduct the study. The patient’s approval may be revoked at any time. Treatment may only be administered once the patient has been informed as to why the treatment is necessary and provided with the details and benefits prior to giving his/her consent. In the case of a patient under 18 years old, or, one who lacks the ability to make decisions, the patient’s legal representative(s) or guardian(s) should provide consent. If the patient is to be admitted to a public hospital or treatment facility, his/her signed consent is necessary. Research is permitted in the case of patients with mental impairments who are either facing dangerous conditions or compulsory treatment is required.

Additional Resources
(A) (WMA Guidance) Declaration of Helsinki (Thai) (October 19, 2013)
World Medical Association
(B) (Document) Nuremberg Code (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Council for International Organizations of Medical Sciences (CIOMS)
Nuffield Council on Bioethics
Investigational Products > Definition of Investigational Product
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 7.1 and Annex 5
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Appendix 1
(3) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct – Thai) (Last Amended April 16, 2019) (Effective Date: October 13, 2019)
National Assembly
Relevant Sections: General Provisions (4)
(4) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.33
Summary

Overview

As specified in G-ResEthics, the Thai government complies with the Thai-ICH-GCPs, which defines an investigational product as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.

G-ResEthics states that an investigational drug used in a clinical trial falls into one (1) of four (4) categories:

  • new drugs
  • unregistered drugs in Thailand
  • registered drugs by the national drug authority, but being studied in new doses or indications not previously approved
  • locally produced drugs that require efficacy testing

According to TFDA-ClinDrugReqs, drugs used in clinical trials may be modern drugs or traditional drugs, which are defined by the DrugAct as follows:

  • “Modern drug” means a drug intended for use in the practice of modern medicine or the cure of an animal disease
  • “Traditional drug” means a drug intended for use in the practice of traditional medicine or the cure of an animal disease which appears in a pharmacopoeia of traditional drugs notified by the Minister, or a drug notified by the Minister as a traditional drug, or a drug with a formula that has been registered as a traditional drug
Additional Resources
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.33
Investigational Products > Manufacturing & Import
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 1.1-1.4, 1.9, 1.11, 1.13, and Appendices 1-4, 7-11, and 18
(2) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct – Thai) (Last Amended April 16, 2019) (Effective Date: October 13, 2019)
National Assembly
Relevant Sections: Chapter I (10), Chapter II (12), Chapter III (25 and 27), and Chapter V (46)
(3) (Regulation) Notification of Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 5
(4) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
(5) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (June 19, 2009) (Effective Date: July 9, 2009)
Ministry of Public Health
(6) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (May 28, 2018) (Effective Date: September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 2-3, 5, and 10
(7) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (WHO 1) (PubGuide-ClinDrugReqs - Thai) (Effective Date: 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(8) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research Biomedical Case (1) (PubGuide-ClinBiolProdReqs - Thai) (Effective Date: 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(9) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 2-3, 5-6, and 10
(10) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Notice: Preface, 2-3, and 5
Summary

Overview

According to TFDA-ClinDrugReqs, the DrugAct, ECReg&Proc-2018, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017, and Additional Resource (A), the Thai Food and Drug Administration (Thai FDA) is responsible for authorizing the manufacture of investigational products (IPs) in Thailand. The Thai FDA will approve the manufacture of an IP after the clinical trial application has been approved.

The Thai FDA is also responsible for authorizing the import of IPs. The Thai FDA’s approval of a drug import permit application for clinical trial purposes serves as the import license. Additional Resource (B) provides access to this application form, which is referred to as the Health Product Classification application form or the NorYorMor1 application form by the Thai FDA.

In addition, as per TFDA-ClinDrugReqs, the DrugAct, and Additional Resource (A), the Thai FDA requires the manufacturer to provide the following:

  • Evidence of manufacture under conditions compliant with current codes of Good Manufacturing Practice
  • A Certificate of Analysis for each batch of IPs (must be in Thai if the manufacturer is foreign)
  • A Certificate of Free Sale
  • For a drug registered in a foreign country, Certificate of Product (CPP)/Certificate of Free Sale (CFS)/evidence of registration from the Drug Control Department from that country. A qualified translator must certify translations of these documents.

TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017 also state that the IP must be manufactured in accordance with Good Manufacturing Practice guidelines.

According to TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the import permit will expire in four (4) years from the date of issuance. TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017 further note that if the study is still ongoing after the expiry date or the amount of drug approved for import is insufficient, the applicant can resubmit the application.

The DrugAct further specifies that a license will remain valid until December 31st of the year of issue. The license holder who would like to renew his/her license must file an application for renewal prior to the license expiration date. Once the renewal application has been filed, the license holder may continue to conduct business unless his/her renewal request is denied. A license holder whose license has expired for not more than one (1) month may file an exemption indicating the reason for obtaining a license extension. However, an application renewal request submitted after one (1) month from the date of license expiration is not permitted. In the event that the Thai FDA does not issue or grant a license renewal request, the applicant may appeal in writing to the Minister within 30 days from the date of receiving the notice rejecting his/her request. The applicant may obtain a temporary permit to operate his/her business until a final decision is issued by the Minister.

TFDA-ClinDrugReqs also states that the quantity of the IP must be calculated based on the number of study participants of each institute for the whole study duration in accordance with the information in the study protocol. The amount of the IP can exceed 20% to cover drug damage. Please refer to TFDA-ClinDrugReqs for more detailed IP supply requirements.

Additional Resources
Thai Food and Drug Administration, Ministry of Public Health
Thai Food and Drug Administration, Ministry of Public Health
Investigational Products > IMP/IND Quality Requirements
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (6.2, 12.2, and 13)
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 1.7, 1.11, 1.13, and Appendices 2-3, 7-11, and 18
(3) (Regulation) Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (May 28, 2018) (Effective Date: September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3
(4) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Notice: 3
(5) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (September 17, 2018) (Effective Date: September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3
(6) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct – Thai) (Last Amended April 16, 2019) (Effective Date: October 13, 2019)
National Assembly
Relevant Sections: Chapter III (25 and 27)
(7) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.36, 5.14, and 7
Summary

Overview

In accordance with TFDA-ClinDrugReqs, G-ResEthics, and the Thai-ICH-GCPs, the sponsor or his/her designated contract research organization (CRO) is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The sponsor should also update the IB as significant new information becomes available.

IB Content Requirements

As specified in G-ResEthics and TFDA-ClinDrugReqs, the IB must comply with the Thai-ICH-GCPs and provide coverage of the following areas:

  • Physical, chemical, and pharmaceutical properties and formulation parameters
  • Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
  • Effects of IP in humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; regulatory and post marketing experiences)
  • Summary of data and guidance for the investigator(s)
  • Bibliography

See Section 7 of the Thai-ICH-GCPs for detailed content guidelines.

TFDA-ClinDrugReqs also indicates that evidence must be provided that the IB has been submitted to the ethics committee.

As defined in G-ResEthics and the Thai-ICH-GCPs, the sponsor is also accountable for supplying the IP, including the comparator(s) and placebo, if applicable.

TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017 also state that the IP must be manufactured in accordance with Good Manufacturing Practice (GMP) guidelines.

(See the Investigational Products topic, Product Management subtopic for additional information on IP supply, storage, and handling requirements).

Certificate of Analysis and Drug Manufacturing Certificate Requirements

As stated in TFDA-ClinDrugReqs, the DrugAct, and Additional Resource (B), the Thai Food and Drug Administration (Thai FDA) requires the manufacturer to provide the following:

  • Evidence of manufacture under conditions compliant with current GMPs
  • A Certificate of Analysis for each batch of IPs (must be in Thai if the manufacturer is foreign)
  • A drug registered in a foreign country is required to have a Certificate of Product (CPP)/Certificate of Free Sale (CFS)/evidence of registration from the Drug Control Department from that country and certified by a qualified translator
  • A Certificate of Free Sale

(See Clinical Trial Lifecycle topic, Submission Process and Submission Content subtopics for detailed application requirements).

Additional Resources
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.36, 5.14, and 7
Thai Food and Drug Administration, Ministry of Public Health
Investigational Products > Labeling & Packaging
Last content review/update: August 29, 2019
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (May 26, 2018) (Effective Date: May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.5 and Appendices 2-3
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (13.1)
(3) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 5.13
Summary

Overview

Investigational product (IP) labeling in Thailand must comply with the requirements set forth in TFDA-ClinDrugReqs, G-ResEthics, the Thai-ICH-GCPs, and Additional Resource (A), which are also described in Additional Resource (B). G-ResEthics and the Thai-ICH-GCPs, states that the IP must be coded and labeled in a manner that protects blinding, if applicable. The TFDA-ClinDrugReqs specifies that the drug labels must include the following information in Thai or English:

  • Drug name or code and strength of active ingredient
  • Research project code and/or project name
  • Number or letter of production
  • How to use the drug if the participant(s) are using the drug by him/herself (e.g., taking drugs home for use). Instructions should be in Thai or in language that the participant(s) understand
  • Sponsor name and address
  • Expiration or retest date
  • Storage conditions
  • Include a message stating "For Research Only" in Thai

According to an in-country subject matter expert, the label or picture of the label of all containers must also be similar to the real label. In addition, in the event the label is smaller than three (3) square inches, the label should include items in the first three (3) bullets listed above.

Additional Resources
Thai Food and Drug Administration, Ministry of Public Health
Thai Food and Drug Administration, Ministry of Public Health
(D) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.13
Investigational Products > Product Management
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (5.11, 6.2, 13 and 14)
(2) (Guidance) ICH Good Clinical Practice Guideline – Thai Translation (Thai-ICH-GCPs – Thai) (July 2000)
Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.33, 4.9, 5.5, 5.13-5.14, and 7
Summary

Overview

In accordance with G-ResEthics and the Thai-ICH-GCPs, the sponsor or his/her designated contract research organization (CRO) is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data.

Investigational Product Supply, Storage, and Handling Requirements

As defined in G-ResEthics and the Thai-ICH-GCPs the sponsor or his/her designated CRO must also supply the investigator(s)/institution(s) with the IPs, including the comparator(s) and placebo, if applicable. The sponsor or his/her designated CRO should not supply either party with the IP(s) until he/she obtains approval from the Thai Food and Drug Administration (Thai FDA) and the Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC) and/or the institutional ethics committee (EC).

G-ResEthics and the Thai-ICH-GCPs specify that the sponsor or his/her designated CRO must ensure the following:

  • Timely delivery of the IP(s)
  • Records maintained for document shipment of the IP(s)
  • Written procedures including instructions for handling and storage of the IP(s), adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor
  • IP product quality and stability over the period of use
  • IP manufactured according to any applicable Good Manufacturing Practices (GMPs)
  • Proper coding, packaging, and labeling of the IP(s)
  • Acceptable IP handling and storage conditions and shelf-life

Refer to the G-ResEthics and the Thai-ICH-GCPs for detailed sponsor-related IP requirements.

Record Requirements

As per G-ResEthics and the Thai-ICH-GCPs, the sponsor should inform the investigator(s) and institution(s) in writing of the need for record retention and should notify the investigator(s) and institution(s) in writing when the trial related records are no longer needed. Additionally, the sponsor must ensure sufficient quantities of the IP(s) used in the trial to reconfirm specifications, should this become necessary, and should maintain records of batch sample analyses and characteristics.

All sponsor-specific essential documents should be retained for at least two (2) years after formal discontinuation of the trial or in conformance with applicable regulatory requirements.

Additional Resources
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.33, 4.9, 5.5, 5.13-5.14, and 7
Specimens > Definition of Specimen
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 1.4, 7.5-7.7, and Annex 8
Summary

Overview

In Thailand, a specimen is generally referred to as biological material. As delineated in G-ResEthics, biological material is defined as original material, progeny, and unmodified derivatives. In the Material Transfer Agreement template provided in G-ResEthics, material covered by the agreement includes all living or dead biological materials and any replicated or derived cells or DNA molecules.

G-ResEthics collectively classifies biomedical research as those studies that include information from a participant’s medical records or databases; laboratory specimens; bodily fluids; human tissues; and studies about the physiology, biochemistry, pathology, biochemistry, and psychology of typical participants.

In addition, G-ResEthics specifically defines human tissue samples as anything being taken out or excreted from a human body or a corpse. These samples may also include other tissues, blood, secretions, and excretions from all organ systems to be used for the diagnosis of a disease or for other purposes.

Please refer to G-ResEthics for more specific definitions for selected terms including progeny and unmodified derivatives.

Additional Resources
No additional resources
Specimens > Specimen Import & Export
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 7.5 and Annex 8
Summary

Overview

Information is currently unavailable regarding the Thai Food and Drug Administration (Thai FDA)’s role in approving the import and export of biological specimens. However, G-ResEthics does state that in the case of the transfer of biological materials, the sponsor must complete the Material Transfer Agreement (MTA) form (Annex 8) to obtain or transfer biological materials for research purposes. An MTA form must also be used to transfer human tissue samples to other institutions.

See also Additional Resource (A) for Material Transfer Agreement and Material Transfer Record forms provided by the Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC). The MOPH ERC is one (1) of the ethics committees currently approved by the Thai FDA to review and approve clinical trial protocols.

Additional Resources
(A) (ERC Guidelines) Guidelines and Procedures for Conducting Research on Human Subjects (Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Material Transfer Agreement (p. 83) and Material Transfer Record (p. 87)
Specimens > Consent for Specimen
Last content review/update: August 29, 2019
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai(December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 3.1 and 7.5-7.7
Summary

Overview

In accordance with G-ResEthics, prior to collecting, storing, or using a research participant’s biological specimen(s), written consent must be obtained from the participant and/or his/her legal representative(s).

As per G-ResEthics, the investigator(s) are responsible for clarifying to the participant and his/her legal representative(s) whether the biological materials collected from the study will be destroyed. If the samples will be used, a clear explanation must be provided as to how the samples will be stored, plans for future use, and whether such use is limited. In addition, the investigator(s) must inform the participants whether any products will be derived from the biological materials collected during the study. (See the Informed Consent topic, Required Elements and Participant Rights subtopics for additional information on informed consent).

Human Tissue Sample Consent Requirements

G-ResEthics states that written consent should be obtained from the donor or the giver of the tissue samples. The general requirements for consent must be met, including the investigator(s) obtaining institutional ethics committee (EC) review and approval of the research protocol and for complying with ethical guidelines in compliance with the applicable laws and regulations when conducting research using tissue samples. The guidelines should provide procedures for tissue sample collection, processing, distribution, disposal, and storage for the duration of the research or for future use. The participant or his/her legal representative(s) must be given detailed information about how the samples will be used and stored, and about their right to request the samples be destroyed when the research is complete.

In addition, per G-ResEthics, for retrospective studies using stored human tissue samples, the institution and the EC should establish the rules and regulations to decide when the investigator can waive a donor’s informed consent in order to use stored tissue samples for research. Refer to Section 7.5 of G-ResEthics for detailed information.

Human Genetic Research Consent Requirements

G-ResEthics states that the investigator or institution must obtain consent for human genetic research. Investigators and institutions must comply with numerous requirements to ensure participant consent, protection, and privacy rights are upheld with regard to the storage of genetic materials. See Sections 7.6 and 7.7 of G-ResEthics for detailed coverage of genetic research consent requirements.

Additional Resources
No additional resources
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