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
Import & Export
Consent for Specimens
Thailand
QUICK FACTS
Clinical trial application languageUnspecified
Parallel regulatory and ethical review permittedYes
Clinical trial registration requiredNo
In-country sponsor presence/representation requiredUnclear
Age of minorsUnder 20
Specimens export allowedUnspecified
Regulatory Authority > Regulatory Authority
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Last content review/update: October 09, 2017. Submit updates or comments.
SUMMARY
Overview
According to Additional Resource (A), Thailand does not have legislation that specifically mandates the Thai Food and Drug Administration (Thai FDA)’s authority to approve, oversee, and inspect clinical trials. However, as per the BE2510Amdmts, the TFDA-ClinDrugReqs, the BE2532, the BE2552, the TFDA-ClinDrugLicenseReqs, the PubGuide-ClinDrugReqs, the PubGuide-ClinBiolProdReqs and the TFDA-ClinDrugImprt2017, the 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 BE2510Amdmts and Additional Resources (B) and (C), 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. It is also authorized to ensure the quality, safety, and efficacy of health products including foods, drugs, cosmetics, and medical devices in Thailand.
 
According to the BE2510Amdmts 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 BE2510Amdmts). The board must consist of MOPH departmental directors-general and representatives from related organizations, as well as five (5) to nine (9) drug experts. Chaired by the Permanent Secretary of the MOPH, the Committee is appointed every two (2) years by the Minister of Public Health. 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. See Additional Resource (D) for the complete list of subcommittees.
 
In addition, per 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.
 
According to TFDA-ClinDrugImprt2017, the Thai FDA has 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
Amphur Muang
Nonthaburi 11000
Thailand
 
Phone: Int. +66 2 590 7171 or Int. +66 2 5907160
Fax: Int. +66 2 590 7170, +66 2 591 8390, or +66 2 591 8489
Email: drug@fda.moph.go.th
 
 
ADDITIONAL RESOURCES
Practical Law
 
(B) (Website) Organization Structure of Thai FDA (Current as of September 6, 2017)
Thai Food and Drug Administration, Ministry of Public Health
 
(C) (Website) The Roles and Responsibilities of Thai FDA (Current as of September 6, 2017)
Thai Food and Drug Administration, Ministry of Public Health
 
(D) (Website) Bureau of Drug Control - Laws and Regulations (Current as of September 6, 2017)
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
 
(G) (Presentation) Drug Control and Registration (2010)
Siriporn Chawanon, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
REQUIREMENTS
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (Thai) (Last Amended December 31, 1987)
National Assembly
 
Relevant Sections: Section 4, Chapter I (6, 7, 10, and 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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
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) (BE2532 - 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 (BE2552 - 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
 
(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
 
 
Regulatory Authority > Scope of Assessment
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SUMMARY
Overview
In accordance with the BE2510Amdmts, the TFDA-ClinDrugReqs, the BE2532, and the BE2552, the TFDA-ClinDrugLicenseReqs, the PubGuide-ClinDrugReqs, the PubGuide-ClinBiolProdReqs, 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 per the G-ResEthics, and Additional Resource (A), 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 which required efficacy testing.
 
As indicated in the TFDA-ClinDrugReqs and the ECReg&Proc, the Thai FDA’s approval of a drug importation permit is dependent upon obtaining proof of ethics committee (EC) approval to conduct the clinical trial by a Thai FDA approved institutional EC. Per TFDA-ClinDrugLicenseReqs 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 the TFDA-ClinDrugReqs and described in Additional Resource (B), the Thai FDA coordinates the review of applications submitted to obtain drug import permits for clinical trial purposes. Per the PubGuide-ClinDrugReqs, the PubGuide-ClinBiolProdReqs, and Additional Resources (A) and (C), upon receipt of an application package, the Thai FDA’s One Stop Service Center (OSSC) 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 applicant 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.
 
According to the TFDA-ClinDrugReqs, the TFDA-ClinDrugLicenseReqs, and TFDA-ClinDrugImprt2017, the import permit will expire in four (4) years from the date of issuance. If the study is still ongoing after the expiry date or the amount of drug is insufficient, the applicant can resubmit the application.
(See the Clinical Trial Lifecycle topic, Submission Content subtopic for submission requirements.)
 
ADDITIONAL RESOURCES
(A) (Presentation) Drug Control and Registration (2010)
Siriporn Chawanon, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Practical Law
 
Thai Food and Drug Administration, Ministry of Public Health
 
(D) (Website) Thai FDA One Stop Service Center - Pharmaceutical Products (English and Thai) (Current as of September 6, 2017)
Thai Food and Drug Administration, Ministry of Public Health
 
 
REQUIREMENTS
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (Thai) (September 2001)
National Assembly
 
Relevant Sections: Section 4, Chapter I (10), 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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: Preface, 1.9, 3.1, 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) (BE2532 - 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 (BE2552 - 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
 
(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
 
(9) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: 7
 
(10) (Regulation) Notification of Food and Drug Administration: The Regulations, Procedures and Conditions to Recognize Ethics Committee in Human Research Involving Drug (ECReg&Proc - Thai) (August 8, 2013)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Regulatory Authority > Regulatory Fees
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SUMMARY

No relevant provisions

 

ADDITIONAL RESOURCES

No additional resources

 

REQUIREMENTS

No applicable regulatory requirements

Ethics Committee > Ethics Committee
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SUMMARY
Overview
As per the TFDA-ClinDrugReqs, the TFDA-ClinDrugLicenseReqs, and TFDA-ClinDrugImprt2017 and the ECReg&Proc, 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).
 
As delineated in the ECReg&Proc, the EC is responsible for reviewing and approving protocols for clinical research involving drugs to be imported or ordered for use in the country. Once the clinical protocol has been approved, the Thai FDA will review the drug import permit application for the study drug that must only be used at the specific study site approved by the EC.
 
According to an in-country subject matter expert, the Thai FDA has currently approved 15 ECs, including the Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC). According to the ECReg&Proc, the Thai FDA will post 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.
 
An additional approval letter from a special ethics committee may also be required for certain types of studies (e.g., HIV vaccine and cell transplant studies). More information is not available at this time regarding these special ethics committees.
 
Per Additional Resource (A), the MOPH’s ERC is also responsible for EC oversight and for the promotion and coordination of research in Thailand.
 
EC Composition
As per the 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
The ECReg&Proc, 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
Terms of Reference, Review Procedures, and Meeting Schedule
As delineated in the G-ResEthics and the ECReg&Proc, ECs must conduct clinical protocol reviews according to the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs), within 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 the G-ResEthics and the ECReg&Proc.
 
ADDITIONAL RESOURCES
Ministry of Public Health
 
Practical Law
 
(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: 1.27 and 3.3
 
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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: 1.11
 
(2) (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
 
(3) (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 (Regulation)
 
(4) (Regulation) Notification of Food and Drug Administration: The Regulations, Procedures and Conditions to Recognize Ethics Committee in Human Research Involving Drug (ECReg&Proc - Thai) (August 8, 2013)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
(5) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: Chapter 6
 
 
Ethics Committee > Scope of Review
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SUMMARY
Overview
As stated in the G-ResEthics and the ECReg&Proc, 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 to 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. See the, the G-ResEthics, and the ECReg&Proc, for detailed ethical review guidelines. Also see Additional Resource (A) for details specific to the MOPH ERC.
 
Role in Clinical Trial Approval Process
Per the TFDA-ClinDrugReqs and the ECReg&Proc, the Thai FDA’s approval of a drug import permit application to conduct a clinical trial is dependent upon obtaining approval by a Thai FDA approved institutional EC. Per TFDA-ClinDrugLicenseReqs 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. Per TFDA-ClinDrugImprt2017, the EC approval must be provided to the Thai FDA within 14 days of receiving the decision.
 
In the instance of a multicenter clinical trial, the 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, the 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 the 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)
 
REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (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: The Regulations, Procedures and Conditions to Recognize Ethics Committee in Human Research Involving Drug (ECReg&Proc - Thai) (August 8, 2013)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
(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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: 1.9
 
(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
 
(5) (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
 
Ethics Committee > Ethics Committee Fees
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SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Ethics Committee > Authorizing Body
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SUMMARY
Overview
As indicated in the ECReg&Proc, the TFDA-ClinDrugReqs, the BE2532, and the BE2552, institutional ethics committees (EC), 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.
 
Per the ECReg&Proc, authorized ECs must either be within the institute under the MOPH, a private institution/hospital that complies with the BE2541, or a non-profit partnership of the MOPH. Additionally, the authorized ECs must have the following qualifications:
  • Be qualified according to the laws or government regulations related to research or service related to the research
  • Have a clearly defined structure
  • Have the right to vote and comment on the research without involvement of investigator or sponsor, and no direct and indirect interest or conflict of interest with the investigator or clinical research
  • Be trained on ethics or other aspects in research and clinical research in humans at least once every two (2) years while on duty
  • Have experience in reviewing human research involving experimental drugs for at least 10 studies
As per the ECReg&Proc, the acceptance letter issued by the Thai FDA is valid for two (2) years. Each EC is required to submit an annual report to the Thai FDA and to apply for an acceptance extension by 60 days before the expiry date.
 
ADDITIONAL RESOURCES

No additional resources

 

REQUIREMENTS
(1) (Regulation) Notification of Food and Drug Administration: The Regulations, Procedures and Conditions to Recognize Ethics Committee in Human Research Involving Drug (ECReg&Proc - Thai) (August 8, 2013)
Bureau of Drug Control, Thai Food and Drug
Administration, Ministry of Public Health
 
(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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: 1.11
 
(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) (BE2532 - Thai) (August 1, 1989)
Ministry of Public Health, Thailand
 
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 (BE2552 - Thai) (June 19, 2009) (Effective Date: July 9, 2009)
Ministry of Public Health
 
Relevant Sections: Article 1 (Clauses 2 and 3)
 
(5) (Legislation) Sanatorium Act, B.E. 2541 (BE2541, unofficial English translation) (Thai) (March 15, 1998)
National Assembly
 
Clinical Trial Lifecycle > Submission Process
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SUMMARY
Overview
In accordance with the BE2510Amdmts, the TFDA-ClinDrugReqs, the BE2532, the BE2552, the TFDA-ClinDrugLicenseReqs, the PubGuide-ClinDrugReqs, the PubGuide-ClinBiolProdReqs, and the 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 the TFDA-ClinDrugReqs and the ECReg&Proc, the Thai FDA’s review and approval of a drug importation permit is dependent upon obtaining proof of ethics committee (EC) approval to conduct the clinical trial by a Thai FDA approved EC. Per TFDA-ClinDrugLicenseReqs 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
The PubGuide-ClinDrugReqs provides the most complete address information regarding submitting the application to be screened by the Thai FDA’s One Stop Service Center (OSSC), followed by where to submit the application for review and approval by the Thai FDA Bureau of Drug Control review. Additional Resource (A) provides access to the clinical trial/drug import permit 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 Center
Food and Drug Administration, 1st Floor
Ministry of Public Health
88/24 Tiwanond Road
Nonthaburi 11000
Thailand
Phone: 02.590.74124
 
To track status and get the result of the application:
Research Building
2, Floor 3, Room 315
Food and Drug Administration, 1st Floor
Ministry of Public Health
88/24 Tiwanond Road
Nonthaburi 11000
Thailand
Phone: 02.590.7061
 
Assembly and Number of Copies
As per the TFDA-ClinDrugReqs, the PubGuide-ClinDrugReqs, the PubGuide-ClinBiolProdReqs, and Additional Resource (C), applicants must submit one (1) original set and two (2) copies of the completed Health Product Classification (NorYorMor1) application form (Additional Resources (A) and (C)) to the Thai FDA as well as one complete set of application files (MS Word or PDF) on a CD.
 
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 the G-ResEthics, each EC should establish its own requirements for protocol submission along with the required documents including the application, number of copies of research protocol to be submitted, the patient information sheet, informed consent form, case report form, and should communicate to personnel or staff within the institution.
 
Language Requirements
While there is no specified language requirement for documents to be submitted to the TFDA, Thai and English appear to be the preferred languages. The TFDA-ClinDrugReqs, the PubGuide-ClinDrugReqs, the PubGuide-ClinBiolProdReqs, and Additional Resources (C) and (E) indicate that the packaging and labeling information should 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 the TFDA-ClinDrugReqs, 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 Center - Pharmaceutical Products (English and Thai) (Current as of September 6, 2017)
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
 
REQUIREMENTS
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (Thai) (Last Amended December 31, 1987)
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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: Preface, 1.9, 3.1, and Appendices 1-5, 11, 13, 14
 
(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) (BE2532 - 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 (BE2552 - 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
 
(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
 
(9) Regulation) Notification of Food and Drug Administration: The Regulations, Procedures and Conditions to Recognize Ethics Committee in Human Research Involving Drug (ECReg&Proc - Thai) (August 8, 2013)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: Form EC-1
 
(10) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: 6.1
 
Clinical Trial Lifecycle > Submission Content
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SUMMARY
Overview
As set forth in the TFDA-ClinDrugReqs, the BE2532, the BE2552, the ECReg&Proc, the TFDA-ClinDrugLicenseReqs, the PubGuide-ClinDrugReqs, the PubGuide-ClinBiolProdReqs, and the TFDA-ClinDrugImprt2017, the Thai Food and Drug Administration (Thai FDA)’s approval of a drug importation permit 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 the TFDA-ClinDrugReqs, the PubGuide-ClinDrugReqs, the PubGuide-ClinBiolProdReqs, and Additional Resource (A), applicants 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 Permit 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 the TFDA-ClinDrugImprt2017, it must be submitted no later than 14 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 (E) 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 applicants to submit the following documentation for ethics approval:
  • Protocol one (1) original set and 20 copies in Thai, 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 the G-ResEthics, each EC should establish its own requirements for protocol submission along with the required documents including the application, number of copies of research protocol to be submitted, the patient information sheet, informed consent form, case report form, and should communicate to personnel or staff within the institution.
 
Clinical Protocol
As delineated in the TFDA-ClinDrugReqs and the 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
  • 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
  • IMPs to be used
For complete protocol requirements, refer to the TFDA-ClinDrugReqs, Annex 6 of the G-ResEthics, which is directly taken from the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs), and the ICH Harmonised Tripartite Guideline - Structure and Content of Clinical Study Reports (E3)G-ResEthics.
 
In the instance of a multicenter clinical trial, the 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 Guideline) 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
 
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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
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 1-5
 
(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) (BE2532 - 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 (BE2552 - 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: The Regulations, Procedures and Conditions to Recognize Ethics Committee in Human Research Involving Drug (ECReg&Proc - Thai) (August 8, 2013)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
(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
 
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 Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
 
(9) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: Annex 6
 
Clinical Trial Lifecycle > Timeline of Review
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SUMMARY
Overview
As set forth in the TFDA-ClinDrugReqs, the ECReg&Proc, the BE2532, the BE2552, the TFDA-ClinDrugLicenseReqs, the PubGuide-ClinDrugReqs, the PubGuide-ClinBiolProdReqs, and the TFDA-ClinDrugImprt2017, the Thai Food and Drug Administration (Thai FDA)’s  approval of a drug importation permit is dependent upon obtaining proof of ethics committee (EC) approval to conduct the clinical trial by a Thai FDA approved institutional EC. Per TFDA-ClinDrugLicenseReqs 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 the BE2559, the BE2559-Attachmt, the PubGuide-ClinDrugReqs, the 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 BE2559-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 the TFDA-ClinDrugReqs and Additional Resources (B), (C), and (D), the Thai FDA coordinates the review of applications submitted to obtain drug import permits for clinical trial purposes. Per Additional Resource (B), upon receipt of a drug application package, the One Stop Service 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 permit. If the specialist approves the permit, the Division officer records the specialist’s decision in the data system, and, if appropriate, a drug permit is issued. The entire IAINDD process takes 18 days and 5 hours.
 
Additional Resource (C) indicates that the application review process for placebo import permits 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 permit 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 the 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 Center - Pharmaceutical Products (English and Thai) (Current as of September 6, 2017)
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
 
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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
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
 
(2) (Regulation) Notification of Food and Drug Administration: The Regulations, Procedures and Conditions to Recognize Ethics Committee in Human Research Involving Drug (ECReg&Proc - Thai) (August 8, 2013)
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) (BE2532 - 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 (BE2552 - 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
 
(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
 
(9) (Regulation) Notification of Food and Drug Administration, Subject: Period for Providing Public Services B.E. 2559 (BE2559) (May 13, 2016)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
(10) (Regulation) Attachment for the Notification of the Food and Drug Administration, Subject: Period for Providing Public Services B.E. 2559 (BE2559-Attachmt) (May 13, 2016)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
(11) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: Annex 6
 
Clinical Trial Lifecycle > Trial Initiation
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SUMMARY
Overview
In accordance with the TFDA-ClinDrugReqs, the ECReg&Proc, the BE2532, the BE2552, the TFDA-ClinDrugLicenseReqs, the PubGuide-ClinDrugReqs, the PubGuide-ClinBiolProdReqs, and the TFDA-ClinDrugImprt2017, a clinical trial can only commence after an applicant 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 applicant’s receipt of these approvals. See the Ethics Committee topic, Ethics Committee subtopic for detailed institutional EC requirements.
 
According to the TFDA-ClinDrugReqs, the ECReg&Proc, the BE2532, the BE2552, the TFDA-ClinDrugLicenseReqs, the PubGuide-ClinDrugReqs, the PubGuide-ClinBiolProdReqs, the TFDA-ClinDrugImprt2017, and BE2510Amdmts, the Thai FDA’s approval of a drug import permit application for clinical trial purposes also serves as an import license that allows the applicant to import investigational drugs into Thailand. According to the TFDA-ClinDrugReqs, the TFDA-ClinDrugLicenseReqs, and the TFDA-ClinDrugImprt2017, the import permit will expire in four (4) years from the date of issuance. If the study is still ongoing after the expiry date or the amount of drug is insufficient, the applicant can resubmit the application. (See the Investigational Products topic, Manufacturing & Import subtopic for additional information).
 
The 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 International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (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
The G-ResEthics requires the sponsor to sign a letter of agreement with the participating institution(s) before the trial begins.
 
EC Confirmation of Review and Approval
As per the TFDA-ClinDrugReqs, the TFDA-ClinDrugLicenseReqs, the TFDA-ClinDrugImprt2017,and the ECReg&Proc, clinical trials require institutional level ethics committee (EC) approval for each trial site from an EC recognized by the Thai FDA. As delineated in the ECReg&Proc, the Thai FDA recognized EC is responsible for reviewing and approving clinical research involving drugs to be imported for use in Thailand. (See Ethics Committee topic, Scope of Review subtopic and for additional details on the EC review process).
 
Thailand Clinical Trials Registry
Although the applicable regulatory requirements do not appear to mandate sponsors and investigators to register with the Thai Clinical Trial Registry, it is encouraged. See Additional Resource (D).
 
Data and Safety Monitoring Board
Although the G-AEReptReqs and the G-ResEthics do not appear to mandate establishing a Data Safety Monitoring Board (DSMB), it is encouraged.
 
ADDITIONAL RESOURCES
Practical Law
 
(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
 
(D) (Website) Thai Clinical Trials Registry (Current as of September 6, 2017)
Medican Research Network (MedResNet), Medical Research Foundation
 
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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: Preface, 1.9, 1.11, 3.1, and Appendices 1-4
 
(2) (Regulation) Notification of Food and Drug Administration: The Regulations, Procedures and Conditions to Recognize Ethics Committee in Human Research Involving Drug (ECReg&Proc - Thai) (August 8, 2013)
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) (BE2532 - 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 (BE2552 - 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
 
(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
 
(9) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (Thai)
(Last Amended December 31, 1987)
National Assembly
 
Relevant Sections: Section 4, Chapter I (10), Chapter II (12), and Chapter V (46)
 
(10) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae, Panichkul; Suthee (eds.)
Forum for Ethical Review Committees in Thailand
 
Relevant Sections: Annex 5 (6)
 
(11) (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) (June 2011)
Forum for Ethical Review Committees in Thailand
 
Relevant Sections: Descriptions and Definitions
 
Clinical Trial Lifecycle > Safety Reporting
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SUMMARY
Overview
In accordance with the TFDA-ClinDrugReqs and the G-AEReptReqs, 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
  • Unexpected Adverse Event/Adverse Drug Reaction – A reaction where the nature or severity is inconsistent with the applicable product information
Reporting Requirements for AEs/ADRs
As delineated in the TFDA-ClinDrugReqs, the TFDA-ClinDrugLicenseReqs, and the TFDA-ClinDrugImprt2017, the sponsor and/or the principal investigator (PI) must comply with the Thai Food and Drug Administration (Thai FDA)’s safety monitoring and reporting requirements. The 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 the TFDA-ClinDrugReqs, all SAEs/SADRs must be reported to the Thai FDA within seven (7) working days from the first knowledge of the incident’s occurrence. Any additional relevant information should be sent within eight (8) days of the initial report. For SAEs/SADRs that are not fatal or life-threatening, a detailed report should be sent to the Thai FDA within 15 days from the date of SAE/SADR notification. Refer to Additional Resource (B) for the Thailand Health Product Adverse Event Report Form.
 
Furthermore, per the TFDA-ClinDrugReqs, annual and end of study safety reports must be provided to the Thai FDA. 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. See Appendix 18 in the TFDA-ClinDrugReqs for an example of the reporting form.
 
Investigator Responsibilities
As stated in the 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 (A).
 
Sponsor Responsibilities
According to the G-AEReptReqs and the 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. Also, 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.
 
The G-ResEthics 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 the G-AEReptReqs and the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A). See the G-AEReptReqs for detailed reporting requirements for the investigator and sponsor.
 
Form Completion & Delivery Requirements
As per the 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 (B)) or the Council for International Organizations of Medical Sciences’ (CIOMS’) form (Additional Resource (C)). According to Additional Resources (B) and (D), 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
 
The TFDA-ClinDrugReqs states that to submit a report electronically, individuals may use the HPVC’s Healthcare Product Surveillance System, unless the system is unavailable.
 
Data Safety Monitoring Board
Although the G-ResEthics and the G-AEReptReqs do not appear to mandate establishing a Data Safety Monitoring Board (DSMB), it is encouraged.
 
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: 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
 
(C) (Form) CIOMS Form I (Date unavailable)
Council for International Organizations of Medical Sciences
 
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
 
(F) (Website) Health Product Vigilance Center (HPVC) (Current as of September 6, 2017)
Health Product Vigilance Center (HPVC), Food and Drug Administration, Ministry of Public Health
 
Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program
 
Relevant Sections: Signal Generation and Data Management – Existence of a Form for Reporting Suspected ADRs, and Annex F and G
 
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and 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 18
 
(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) (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) (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
 
(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
 
(5) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: Annex 5 (17)
 
Clinical Trial Lifecycle > Progress Reporting
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SUMMARY
Overview
In accordance with the G-ResEthics, the investigator(s) is responsible for submitting progress reports on the status of the trial and for submitting a final study report.
 
Interim/Progress Reports
As delineated in the G-ResEthics, the investigator(s) must submit progress reports to the ethics committee (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 applicant 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.
 
In addition, according to the TFDA-ClinDrugReqs, the TFDA-ClinDrugLicenseReqs, and the TFDA-ClinDrugImprt2017, the applicant must submit a study progress report annually to the Thai Food and Drug Administration (Thai FDA) between October 1 and 31 every year until the study ends.
 
Final Report
The G-ResEthics requires investigator(s) to submit a final report to the EC upon the trial’s termination.
 
In addition, according to the TFDA-ClinDrugReqs, the TFDA-ClinDrugLicenseReqs, and the TFDA-ClinDrugImprt2017, a summary report at the conclusion or termination of a clinical trial must be submitted to the Thai FDA within 60 days after the close-out of the last study site.
 
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 (A). 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) (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)
 
REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae, Panichkul; Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: 6.6
 
(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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: Preface and Appendix 13
 
(3) (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
 
(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
 
Sponsorship > Definition of Sponsor
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SUMMARY
Overview
As specified in the G-ResEthics, the Thai government complies with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs), which defines a sponsor as an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
 
In accordance with the 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.
 
According to Additional Resource (B), the Ministry of Public Health (MOPH)’s Ethical Review Committee for Research in Human Subjects (ERC), which is one of the ECs approved by the Thai Food and Drug Administration (Thai FDA) to approve clinical research protocols, requires that the sponsor and/or CRO must be legally registered in Thailand. See Additional Resource (B) for more details.
 
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: 1.53 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)
 
REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: Annex 5
 
Sponsorship > Trial Authorization
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SUMMARY
Overview
In accordance with the TFDA-ClinDrugReqs, the ECReg&Proc, the BE2532, the BE2552, the TFDA-ClinDrugLicenseReqs, the PubGuide-ClinDrugReqs, the PubGuide-ClinBiolProdReqs, and the TFDA-ClinDrugImprt2017, the sponsor or his/her contract research organization (CRO) is responsible for submitting a drug import permit application to the Thai Food and Drug Administration (Thai FDA). As per the BE2510Amdmts, the TFDA-ClinDrugReqs, the BE2532, the BE2552, the TFDA-ClinDrugLicenseReqs, the PubGuide-ClinDrugReqs, the PubGuide-ClinBiolProdReqs, and the 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.
 
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
 
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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
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
 
(2) (Regulation) Notification of Food and Drug Administration: The Regulations, Procedures and Conditions to Recognize Ethics Committee in Human Research Involving Drug (ECReg&Proc - Thai) (August 8, 2013)
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) (BE2532 - 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 (BE2552 - 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
 
(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
 
(9) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (Thai) (Last Amended December 31, 1987)
National Assembly
 
Relevant Sections: Section 4, Chapter I (10), Chapter II (12), and Chapter V (46)
 
Sponsorship > Insurance
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SUMMARY
Overview
The G-ResEthics implements the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) which provides some guidance on complying with insurance and indemnity requirements. However, it is unclear whether the Thai regulations explicitly require the sponsor to provide insurance coverage for any unforeseen injury to research participants or to indemnify the investigator and the institution against claims arising from malpractice or negligence.
 
See the Sponsorship topic, Compensation subtopic and Informed Consent topic, Compensation Disclosure subtopic for specific details related to sponsorship compensation obligations.
 
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
 
REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: Annex 5 (8)
 
Sponsorship > Compensation
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SUMMARY
Overview
As specified in the G-ResEthics, 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. (See Informed Consent topic, Compensation Disclosure subtopic for more information on participant compensation rights that must be described during the Informed Consent process).
 
ADDITIONAL RESOURCES

No additional resources

 

REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: 3.2 and Annex 5 (8)
 
Sponsorship > Quality, Data & Records Management
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SUMMARY
Overview
As stated in the 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 International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (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.
 
The TFDA-ClinDrugReqs, the TFDA-ClinDrugLicenseReqs, and the 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 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
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 the G-ResEthics for detailed information on electronic trial data systems.
 
Record Management
As set forth in the G-ResEthics, 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, the G-ResEthics notes 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 Food and Drug Administration (Thai FDA). No specific timeframe is provided for the audit process.
 
Per the TFDA-ClinDrugReqs, the TFDA-ClinDrugLicenseReqs, and the 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
The G-ResEthics 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. The 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 the TFDA-ClinDrugReqs, the TFDA-ClinDrugLicenseReqs, and the 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 17 in the TFDA-ClinDrugReqs contains a sample notification form required to be completed when terminating a research project.)
 
Multicenter Studies
As delineated in the G-ResEthics, 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 ethics committee 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: 5
 
Thai Food and Drug Administration, Ministry of Public Health
 
REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (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)
 
(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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: 4.3 and 4.4, and Appendix 17
 
(3) (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
 
(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
 
Sponsorship > Site/Investigator Selection
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SUMMARY
Overview
The G-ResEthics, which implements the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (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 ICH-GCPs and the 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.
 
Although not specified as a sponsor requirement, the G-ResEthics and the G-AEReptReqs 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: 5
 
REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (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) 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) (June 2011)
Forum for Ethical Review Committees in Thailand
 
Relevant Sections: Descriptions and Definitions, Appendix 3
 
Informed Consent > Documentation Requirements
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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 the G-ResEthics. As per the TFDA-ClinDrugReqs and the G-ResEthics, 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.)
 
The TFDA-ClinDrugReqs and the G-ResEthics state that the investigator(s) must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). The G-ResEthics also specifies 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 of the institutional ECs approved by the Thai FDA.
 
Language Requirements
As stated in the TFDA-ClinDrugReqs, the ICF content and accompanying information (Patient Information Sheet) should be presented in the language of the participant and must be submitted in Thai and translated to English.
 
Documentation Copies
The G-ResEthics states 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.
 
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: 1.7
 
REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (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
 
(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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: 1.7
 
Informed Consent > Required Elements
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SUMMARY
Overview
As delineated in the TFDA-ClinDrugReqs and the 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).
 
No Coercion
As per the G-ResEthics, 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 the TFDA-ClinDrugReqs and the G-ResEthics, 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 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: 1.7
 
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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: 1.7
 
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: 3.1.1 and 3.2
 
Informed Consent > Compensation Disclosure
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SUMMARY
Overview
In accordance with the TFDA-ClinDrugReqs and the G-ResEthics, 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
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. The ICF should also inform all trial participants of any types of expenses that they may incur as a result of participation.
 
Compensation for Injury
As stated in the TFDA-ClinDrugReqs and the G-ResEthics, 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: 1.7
 
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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: 1.7
 
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (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)
 
Informed Consent > Participant Rights
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SUMMARY
Overview
In accordance with the G-ResEthics, Thailand’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The TFDA-ClinDrugReqs and the G-ResEthics 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 the TFDA-ClinDrugReqs and the G-ResEthics, 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.
 
The Right to Information
As delineated in the TFDA-ClinDrugReqs and the G-ResEthics, 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 the TFDA-ClinDrugReqs and the G-ResEthics, 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
The TFDA-ClinDrugReqs and the G-ResEthics 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
The 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: 1.7
 
REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (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) (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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: 1.7
 
Informed Consent > Special Circumstances/Emergencies
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SUMMARY
Overview
The G-ResEthics makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by special circumstances.
 
Waiver of Consent
As per the G-ResEthics, the ethics committee (EC) should establish the conditions under which an informed consent discussion and/or signing the informed consent form (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: 1.7
 
REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (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
 
Informed Consent > Vulnerable Populations
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SUMMARY
Overview
As per the G-ResEthics, 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. The 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. These participants may include hospitalized patients, prisoners, children, the mentally impaired, critically ill and psychotic patients, pregnant women, and the disadvantaged.
 
The 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: 1.7
 
REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: 2.2.2 and 3.4
 
Informed Consent > Children/Minors
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SUMMARY
Overview
According to the ThaiCode, a minor is someone under 20 years of age or married. As set forth in the 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 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) (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: 1.7
 
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) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: 2.2.2 and 3.4
 
Informed Consent > Pregnant Women, Fetuses & Neonates
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SUMMARY
Overview
As per the 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

No additional resources

 

REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: 2.2.2 and 3.4
 
Informed Consent > Prisoners
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SUMMARY
Overview
According to the 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

No additional resources

REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: 2.2.3, 3.2, and 3.4
 
Informed Consent > Mentally Impaired
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SUMMARY
Overview
Per the G-ResEthics, informed consent should be obtained from the legal representatives or guardians of participants for studies involving psychiatric or incompetent patients.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: 3.4.5
 
Investigational Products > Definition of Investigational Product
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SUMMARY
Overview
As specified in the G-ResEthics, the Thai government complies with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (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.
 
The 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 which required efficacy testing
According to the TFDA-ClinDrugReqs, drugs used in clinical trials may be modern drugs or traditional drugs, which are defined by the BE2510Amdmts 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 of which formula has been registered as that of 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
 
REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
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 (BE2510Amdmts) (Thai) (Last Amended December 31, 1987)
National Assembly
 
Relevant Sections: General Provisions (4)
 
Investigational Products > Manufacturing & Import
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SUMMARY
Overview
According to the TFDA-ClinDrugReqs, the BE2510Amdmts, the ECReg&Proc, the BE2532, the BE2552, the TFDA-ClinDrugLicenseReqs, the PubGuide-ClinDrugReqs, the PubGuide-ClinBiolProdReqs, the 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 the TFDA-ClinDrugReqs, the BE2510Amdmts, 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. Translations of these documents must be certified by a qualified translator.
The TFDA-ClinDrugLicenseReqs and the TFDA-ClinDrugImprt2017 also state that the IP must be manufactured in accordance with Good Manufacturing Practice guidelines.
 
According the TFDA-ClinDrugReqs, the TFDA-ClinDrugLicenseReqs, and the TFDA-ClinDrugImprt2017, the import permit expires four (4) years from the date of issuance. 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 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 to the information in the study protocol. The amount of the IP can exceed 20% to cover drug damage. Please refer to the 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
 
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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: Preface, 1.10, 1.12, 3.1, and Appendices 1-4, 10, and 11
 
(2) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (Thai) (Last Amended December 31, 1987)Legal Affairs Group, Thai Food and Drug Administration, Ministry of Public Health
 
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: The Regulations, Procedures and Conditions to Recognize Ethics Committee in Human Research Involving Drug (ECReg&Proc - Thai) (August 8, 2013)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
(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) (BE2532 - 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 (BE2552 - 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) (August 24, 2016) (Effective Date: October 1, 2016)
Office of the Board of Directors, 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 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
 
Investigational Products > IMP/IND Quality Requirements
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SUMMARY
Overview
In accordance with the G-ResEthics, 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 the G-ResEthics and the TFDA-ClinDrugReqs, the IB must comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (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 ICH-GCPs for detailed content guidelines.
 
The TFDA-ClinDrugReqs also indicates that evidence must be provided that the IB has been submitted to the ethics committee.
 
As defined in the G-ResEthics, the sponsor is also accountable for supplying the IP, including the comparator(s) and placebo, if applicable.
 
The TFDA-ClinDrugLicenseReqs and the TFDA-ClinDrugImprt2017 also state that the IP must be manufactured in accordance with Good Manufacturing Practice 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 the Investigational Products topic, Manufacturing & Import subtopic, as per the TFDA-ClinDrugReqs, the BE2510Amdmts, 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: 7
 
Thai Food and Drug Administration, Ministry of Public Health
 
REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: Preface, 1.6, 1.10, 1.12, and Appendices 3, 10, and 11
 
(3) (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
 
(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
 
(5) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (Thai) (Last Amended December 31, 1987)
Legal Affairs Group, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: Chapter III (25 and 27)
 
Investigational Products > Labeling & Packaging
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SUMMARY
Overview
Investigational product (IP) labeling in Thailand must comply with the requirements set forth in the TFDA-ClinDrugReqs, the G-ResEthics, and Additional Resource (A), which are also described in Additional Resource (B). The G-ResEthics 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 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. Also, in the event the label is smaller than 3 square inches, the label should include items in the first three (3) bullets listed above.
 
Per the TFDA-ClinDrugReqs, in cases where additional labeling is required after the drug is introduced in Thailand, the labeling procedures and audit logs and controls must be verifiable.
 
ADDITIONAL RESOURCES
Thai Food and Drug Administration, Ministry of Public Health
 
Practical Law
 
Thai Food and Drug Administration, Ministry of Public Health
 
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 and English) (August 13, 2015) (Effective Date: August 18, 2015)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
 
Relevant Sections: 1.4, Appendix 3
 
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: Annex 5 (13.1)
 
Investigational Products > Product Management
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Last content review/update: September 08, 2017. Submit updates or comments.
SUMMARY
Overview
In accordance with the G-ResEthics, 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 the G-ResEthics, 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).
 
The G-ResEthics specifies 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 for detailed sponsor-related IP requirements.
 
Record Requirements
As per the G-ResEthics, 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 samples 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

No additional resources

 

REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (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)
 
Specimens > Definition of Specimen
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Last content review/update: September 08, 2017. Submit updates or comments.
SUMMARY
Overview
In Thailand, a specimen is generally referred to as biological material. As delineated in the G-ResEthics, biological material is defined as original material, progeny, and unmodified derivatives. In the Material Transfer Agreement template provided in the G-ResEthics, material covered by the agreement includes all living or dead biological materials and any replicated or derived cells or DNA molecules.
 
In addition, the G-ResEthics collectively classifies biomedical research as those studies which 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.
 
Please refer to the G-ResEthics for more specific definitions for selected terms including progeny, unmodified derivatives, vaccines, and human tissue samples.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: 1.4.1, 7.4, 7.5, 7.6, 7.7, and Annex 8
 
Specimens > Import & Export
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Last content review/update: October 09, 2017. Submit updates or comments.
SUMMARY
Overview
According to Additional Resources (A), (B), and (C), the sponsor must obtain approval from the Thai Food and Drug Administration (Thai FDA) to import biological materials into Thailand. Additional Resource (B) states that the procedure for authorizing biological materials is generally the same as is required for drugs. The BE2510Amdmts are also specified as the primary laws that regulate the authorization and import of biologics in Thailand.
 
Thai FDA Application Requirements
As per the G-ResEthics, the sponsor must complete the Material Transfer Agreement (MTA) form to obtain or transfer biological materials for research purposes. An MTA form must also be used to transfer human tissue samples to other institutions.
 
No other information is available at this time on the import or export of biological materials.
 
See Additional Resource (D) for the 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 of the ethics committees currently approved by the Thai FDA to review and approve clinical trial protocols.
 
ADDITIONAL RESOURCES
(A) (Website) Bureau of Drug Control - Laws and Regulations (Current as of September 6, 2017)
Thai Food and Drug Administration, Ministry of Public Health
 
Practical Law
 
(C) (Presentation) Drug Control and Registration (2010)
Siriporn Chawanon, Bureau of Drug Control, 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: Material Transfer Agreement (p. 83) and Material Transfer Record (p. 87)
 
REQUIREMENTS
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (Thai) (Last Amended December 31, 1987)
National Assembly
 
Relevant Sections: Section 4, Chapter I (10), Chapter II (12), and Chapter V (46)
 
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: 7.5 and Annex 8
 
Specimens > Consent for Specimens
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Last content review/update: September 08, 2017. Submit updates or comments.
SUMMARY
Overview
In accordance with the 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 the 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
The G-ResEthics states that written consent should be obtained from the donor or the giver of the samples. The participant must be given detailed information about how the samples will be used, storage duration, and his/her right to request the samples be destroyed when the research is complete.
 
Human Genetic Research Consent Requirements
The 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 the G-ResEthics for consent requirement details.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
 
Relevant Sections: 3.1.1, 7.5, 7.6, and 7.7
 
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