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 languageThai
Parallel regulatory and ethical review permittedNo
Clinical trial registration requiredNo
In-country sponsor presence/representation requiredNo
Age of minorsUnder 20
Specimens export allowedUnspecified
Regulatory Authority > Regulatory Authority
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Last content review/update: July 10, 2017. Submit updates or comments.
SUMMARY

Overview
According to Additional Resources (A) and (B), at this time, 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 G-CTAppDrugImprt, and Additional Resource (C), 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 (D) and (E), 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.

The BE2510Amdmts mandate that the Thai FDA establish a Drug Board to advise the agency’s Secretary-General. The board must consist of MOPH departmental directors-general and representatives from related organizations, as well as five (5) to nine (9) drug experts. Refer to the BE2510Amdmts for a detailed description of the board.
 
According to Additional Resources (A) and (G), the Thai FDA has a Drug Control Division that is appointed every two (2) years by the Minister of Public Health. This division is responsible for advising the Minister on regulatory issues, and for ensuring drug control. The division consists of 14 members who delegate drug control administration to 19 subcommittees. 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 (G) for the complete list of subcommittees. In addition, the Thai FDA’s International Affairs and Investigational New Drug Section within the Drug Control Division is responsible for application review and recommendation for approval.  The Thai FDA then makes the final decision to approve the application.

Contact Information
International Affairs and Investigational New Drug Section
Drug Control Division
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanond Road
Nonthaburi 11000
Thailand

Phone: Int. +66 2 5907167 or Int. +66 2 5907061
Fax: Int. +66 2 590 7061

ADDITIONAL RESOURCES

(A) (Website) Global Health Technologies Coalition – Thailand: Drugs (Current as of September 26, 2014)
Global Health Technologies Coalition, Washington, DC

(B) (Website) Medicinal Product Regulation and Product Liability in Thailand: Overview (Current as of February 1, 2016)
Practical Law, London, UK

(C) (Website) Food and Drug Administration Thailand – Pre-Marketing Control – Licensing (Current as of March 2, 2017)
Thai Food and Drug Administration, Ministry of Public Health, Thailand

(D) (Website) Food and Drug Administration Thailand – Organization Structure (Current as of March 2, 2017)
Thai Food and Drug Administration, Ministry of Public Health, Thailand

(E) (Website) Food and Drug Administration Thailand – Roles and Responsibilities (Current as of March 2, 2017)
Thai Food and Drug Administration, Ministry of Public Health, Thailand

(F) (Website) Food and Drug Administration Thailand – Drug Control Division (Current as of March 2, 2017)
Thai Food and Drug Administration, Ministry of Public Health, Thailand

(G) (Website) Food and Drug Administration Thailand – Laws and Regulations (Current as of March 2, 2017)
Thai Food and Drug Administration, Ministry of Public Health, Thailand

(H) (Presentation) Drug Control and Registration (2010)
Siriporn Chawanon, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

REQUIREMENTS

(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (September 2001)
Legal Affairs Group, Thai Food and Drug Administration, Ministry of Public Health, Thailand

Relevant Sections: Section 4, Chapter I (10), Chapter II (12), and Chapter V (46)

(2) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt - Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

Regulatory Authority > Scope of Assessment
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Last content review/update: June 07, 2017. Submit updates or comments.
SUMMARY

Overview
In accordance with the BE2510Amdmts and the G-CTAppDrugImprt, 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 BE2510Amdmts, the G-ResEthics, and Additional Resources (A) and (B), 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 G-CTAppDrugImprt 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 institutional EC. According to the G-CTAppDrugImprt, the Thai FDA and the EC may not conduct their reviews in parallel.

Clinical Trial Review Process
As set forth in the G-CTAppDrugImprt and Additional Resource (A), the Thai FDA coordinates the review of applications submitted to obtain drug import permits for clinical trial purposes. 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, who is authorized to approve the application. According to an in-country subject matter expert and the G-CTAppDrugImprt, 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) (Website) Food and Drug Administration Thailand – Pre-Marketing Control – Licensing (Current as of March 2, 2017)
Thai Food and Drug Administration, Ministry of Public Health, Thailand

(B) (Presentation) Drug Control and Registration (2010)
Siriporn Chawanon, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health

(C) (Website) Global Health Technologies Coalition – Thailand: Drugs (Current as of September 26, 2014)
Global Health Technologies Coalition, Washington, DC

(D) (Website) Medicinal Product Regulation and Product Liability in Thailand: Overview (February 1, 2016)
Practical Law, London, UK

REQUIREMENTS

(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (September 2001)
Legal Affairs Group, Thai Food and Drug Administration, Ministry of Public Health, Thailand

Relevant Sections: Section 4, Chapter I (10), Chapter II (12), and Chapter V (46)

(2) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division,  Thai Food and Drug Administration, Ministry of Public Health, Thailand

(3) (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 Section: 7

(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, Thailand

Regulatory Authority > Regulatory Fees
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Last content review/update: March 16, 2016. Submit updates or comments.
SUMMARY

Overview
Although no information regarding taxes and fees is currently available from official sources, Additional Resource (A) states that there is no fee associated with submitting an application to import drugs for clinical trial purposes to the Thai Food and Drug Administration (Thai FDA).

ADDITIONAL RESOURCES

(A) (Website) Global Health Technologies Coalition – Thailand: Drugs (Current as of September 26, 2014)
Global Health Technologies Coalition, Washington, DC

REQUIREMENTS

No applicable regulatory requirements

Ethics Committee > Ethics Committee
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Last content review/update: July 10, 2017. Submit updates or comments.
SUMMARY

Overview
As per the G-CTAppDrugImprt 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 Conference on Harmonisation (ICH) Harmonised Tripartite 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

(A) (Website) Ministry of Public Health – Ethical Review Committee for Research in Human Subjects (MOPH ERC) – Roles and Responsibilities (Thai) (Current as of March 14, 2016)
Ministry of Public Health, Thailand

(B) (Website) Medicinal Product Regulation and Product Liability in Thailand: Overview (February 1, 2016)
Practical Law, London, UK

(C) (Document) A Survival Guide for Conducting International Collaborative Research in Thailand (September 2004)
Fogarty AIDS International Training and Research Program, University of California, Berkeley, and University of California, San Francisco

(D) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation, Geneva, Switzerland

REQUIREMENTS

(1) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(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, 2014)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(3) (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 Section: Chapter 6

Ethics Committee > Scope of Review
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Last content review/update: July 19, 2017. Submit updates or comments.
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 (D) for details specific to the MOPH ERC.

Role in Clinical Trial Approval Process
Per the G-CTAppDrugImprt and the ECReg&Proc, the Thai FDA’s review and approval of a drug import permit application to conduct a clinical trial is dependent upon obtaining approval by a Thai FDA approved institutional EC. In addition, the G-CTAppDrugImprt states that the Thai FDA and the ethics reviews may not be conducted in parallel.

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 (D).

ADDITIONAL RESOURCES

(A) (Website) Global Health Technologies Coalition – Thailand: Drugs (Current as of September 26, 2014)
Global Health Technologies Coalition, Washington, DC

(B) (Website) Medicinal Product Regulation and Product Liability in Thailand: Overview (February 1, 2016)
Practical Law, London, UK

(C) (Document) A Survival Guide for Conducting International Collaborative Research in Thailand (September 2004)
Fogarty AIDS International Training and Research Program, University of California, Berkeley, University of California, San Francisco

Relevant Section: 3

(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, Thailand

Relevant Section: 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) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(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, 2014)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health, Thailand

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 and the G-CTAppDrugImprt, 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 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

(A) (Document) A Survival Guide for Conducting International Collaborative Research in Thailand (September 2004)
Fogarty AIDS International Training and Research Program, University of California, Berkeley, and University of California, San Francisco

Relevant Section: 3

REQUIREMENTS

(1) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(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, 2014)
Bureau of Drug Control, Thai Food and Drug
Administration, Ministry of Public Health, Thailand

(3) (Regulation) Sanatorium Act, B.E. 2541 (BE2541) (March 15, 1998)
Government of Thailand

Clinical Trial Lifecycle > Submission Process
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SUMMARY

Overview
In accordance with the BE2510Amdmts and the G-CTAppDrugImprt, 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 G-CTAppDrugImprt, the ECReg&Proc, and as described in Additional Resources (A) and (B), 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. The G-CTAppDrugImprt also states that the Thai FDA and the EC may not conduct their reviews in parallel.

Delivery Address for Clinical Trial Application
Additional Resource (C) 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. However, Additional Resource (A) provides the most complete address information regarding submitting the initial application to be screened by the Thai FDA’s One Stop Service Center, followed by where to submit the application for review and approval by the Thai FDA Drug Control Division review.

Initial applications should be submitted to:

One Stop Service Center
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanond Road
Nonthaburi 11000
Thailand

Screened applications should be submitted to:

International Affairs and Investigational New Drug Section
Drug Control Division
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanond Road
Nonthaburi 11000
Thailand

Assembly and Number of Copies
As per the G-CTAppDrugImprt and Additional Resource (A), applicants must submit two A4-sized hard copies of the completed Health Product Classification (NorYorMor1) application form (Additional Resource (C)) to the Thai FDA.

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 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.

Language Requirements
As per the G-CTAppDrugImprt and Additional Resource (A), the Health Product Classification (NorYorMor1) application form (Additional Resource (C)) should be completed in Thai, with supporting documentation presented in either Thai or English.

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

(A) (Website) Global Health Technologies Coalition – Thailand: Drugs (Current as of September 26, 2014)
Global Health Technologies Coalition, Washington, DC

(B) (Website) Medicinal Product Regulation and Product Liability in Thailand: Overview (February 1, 2016)
Practical Law, London, UK

(C) (Form) Health Product Classification (NorYorMor1) Application Form (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health, Thailand

(D) (Document) A Survival Guide for Conducting International Collaborative Research in Thailand (September 2004)
Fogarty AIDS International Training and Research Program, University of California, Berkeley, and University of California, San Francisco

(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, Thailand

Relevant Section: 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)

REQUIREMENTS

(1) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(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, Thailand

(3) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (September 2001)
Legal Affairs Group, Thai Food and Drug Administration, Ministry of Public Health, Thailand

Relevant Section: Section 4

Clinical Trial Lifecycle > Submission Content
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SUMMARY

Overview
As set forth in the G-CTAppDrugImprt, the ECReg&Proc, and as described in Additional Resources (A) and (B), the Thai Food and Drug Administration (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 institutional EC.

Thai FDA Requirements
As per the G-CTAppDrugImprt and Additional Resource (A), two (2) copies of each of the documents listed below must be submitted 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 (C))
  • Health Product Classification (NorYorMor1) application form (Additional Resource (C))
  • Drug labels for every container (Thai or English)
  • Package Insert (for unregistered 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
  • Estimates of the amount of study drug, comparators, or other goods to be imported
  • Certificate of Analysis
  • Certificate of Free Sale
  • 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 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 (E), 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 (E) for detailed MOPH ERC submission requirements.

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.

Clinical Protocol
As delineated in the G-CTAppDrugImprt and the G-ResEthics, the clinical protocol should include the following elements:

  • 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
  • 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

For complete protocol requirements, refer to the G-CTAppDrugImprt, Annex 6 of the G-ResEthics, and the ICH Harmonised Tripartite Guideline – Structure and Content of Clinical Study Reports (E3).

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 (E) for detailed MOPH ERC submission requirements related to the protocol.

ADDITIONAL RESOURCES

(A) (Website) Global Health Technologies Coalition – Thailand: Drugs (Current as of September 26, 2014)
Global Health Technologies Coalition, Washington, DC

(B) (Website) Medicinal Product Regulation and Product Liability in Thailand: Overview (February 1, 2016)

Practical Law, London, UK

(C) (Form) Health Product Classification (NorYorMor1) Application Form (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health, Thailand

(D) (Document) A Survival Guide for Conducting International Collaborative Research in Thailand (September 2004)
Fogarty AIDS International Training and Research Program, University of California, Berkeley, and University of California, San Francisco

(E) (ERC Guidelines) Guidelines and Procedures for Conducting Research on Human Subjects (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health, Thailand

Relevant Section: 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)

REQUIREMENTS

(1) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(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, Thailand

(3) (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 Section: Annex 6

Clinical Trial Lifecycle > Timeline of Review
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SUMMARY

Overview
As set forth in the G-CTAppDrugImprt, the ECReg&Proc, and as described in Additional Resources (A) and (B), the Thai Food and Drug Administration (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 institutional EC. The G-CTAppDrugImprt also states that the Thai FDA and the EC may not conduct their reviews in parallel.

Thai FDA Approval
Although there are no official timelines specified in the regulatory documentation, according to Additional Resource (A), the Thai FDA’s review and approval process typically takes four (4) weeks.

As set forth in the G-CTAppDrugImprt, and according to Additional Resources (A), (B), and (C), the Thai FDA coordinates the review of applications submitted to obtain drug import permits for clinical trial purposes. Upon receipt of an application package, the One Stop Service Center (OSSC) sends the application package to an officer in the 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 incomplete, the officer will send a notification to the applicant; who has five (5) working days to correct the package. 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, who is authorized to approve the application.

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 (B), 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 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 and timeline.

ADDITIONAL RESOURCES

(A) (Website) Global Health Technologies Coalition – Thailand: Drugs (Current as of September 26, 2014)
Global Health Technologies Coalition, Washington, DC

(B) (Website) Medicinal Product Regulation and Product Liability in Thailand: Overview (February 1, 2016)
Practical Law, London, UK

(C) (Presentation) Drug Control and Registration (2010)
Siriporn Chawanon, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health

(D) (Document) A Survival Guide for Conducting International Collaborative Research in Thailand (September 2004)
Fogarty AIDS International Training and Research Program, University of California, Berkeley, and University of California, San Francisco

(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, Thailand

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)

REQUIREMENTS

(1) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(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, Thailand

 

Clinical Trial Lifecycle > Trial Initiation
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SUMMARY

Overview
In accordance with the G-CTAppDrugImprt, the ECReg&Proc, and according to Additional Resources (A) and (B), 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). In addition, the G-CTAppDrugImprt states that the Thai FDA and the EC may not conduct their reviews in parallel. 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.

As stated in the Regulatory Authority topic, Regulatory Authority subtopic, according to the BE2510Amdmts and Additional Resource (B), 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 an in-country subject matter expert and the G-CTAppDrugImprt, 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 (B) specify that all investigators must also possess appropriate qualifications, training, and experience. Additionally, the clinical trial should be conducted in compliance with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs).

See Additional Resource (E) 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 G-CTAppDrugImprt 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. In addition, the G-CTAppDrugImprt states that the Thai FDA and the ethics reviews may not be conducted in parallel. (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 strongly encouraged. See Additional Resource (F).

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

(A) (Website) Global Health Technologies Coalition – Thailand: Drugs (Current as of September 26, 2014)
Global Health Technologies Coalition, Washington, DC

(B) (Website) Medicinal Product Regulation and Product Liability in Thailand: Overview (February 1, 2016)
Practical Law, London, UK

(C) (Document) A Survival Guide for Conducting International Collaborative Research in Thailand (September 2004)
Fogarty AIDS International Training and Research Program, University of California, Berkeley, and University of California, San Francisco

(D) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

(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, Thailand

Relevant Sections: Ethical Criteria: The Ethical Review Committee for Research in Human Subjects (p. 72)

(F) (Website) Thai Clinical Trials Registry (Current as of March 14, 2016)
Clinical Research Collaboration Network, Medical Research Foundation, Thailand

REQUIREMENTS

(1) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(2) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (September 2001)
Legal Affairs Group, Thai Food and Drug Administration, Ministry of Public Health, Thailand

Relevant Sections: Section 4, Chapter I (10), Chapter II (12), and Chapter V (46)

(3) (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 Section: Annex 5 (1 and 5)

(4) (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 Committee in Thailand, Thailand

Relevant Section: Descriptions and Definitions

Clinical Trial Lifecycle > Safety Reporting
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SUMMARY

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

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

Sponsor Responsibilities
According to 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 Food and Drug Administration (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 SAE reporting form or the Council for International Organizations of Medical Sciences’ (CIOMS’) form (see Additional Resource (A)). The G-CTAppDrugImprt states that AEs/ADRs and SAEs/SADRs must be reported to the Thai FDA, and Additional Resource (B) indicates that the SAE form should be sent to the Thai FDA Drug Control Division at the following address:

International Affairs and Investigational New Drug Section
Drug Control Division
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanond Road
Nonthaburi 11000
Thailand

Neither the Thai Food and Drug Administration (Thai FDA) website nor the G-AEReptReqs provide address information.

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) (Form) Suspect Adverse Reaction Report Form (CIOMS Form I) (Current as of October 28, 2013)
Council for International Organizations of Medical Sciences, Geneva

(B) (Website) Global Health Technologies Coalition – Thailand: Drugs (Current as of September 26, 2014)
Global Health Technologies Coalition, Washington, DC

(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, Thailand

Relevant Section: Ethical Criteria: The Ethical Review Committee for Research in Human Subjects (Revised 2007) (p. 72); Additional Resolution of the Committee (2005) (p. 76)

REQUIREMENTS

(1) (Guidance) Guidance for Adverse Event Report (G-AEReptReqs) (June 2011)
Forum for Ethical Review Committee in Thailand, Thailand

Relevant Sections: Descriptions and Definitions, 1, 2, 4, Appendix 1, Appendix 2, Appendix 3, and Appendix 4

(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 (17)

(3) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

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 G-CTAppDrugImprt and an in-country subject matter expert, the applicant must submit a study progress report to the Thai Food and Drug Administration (Thai FDA) yearly between October 1 and 31 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 G-CTAppDrugImprt and an in-country subject matter expert, notification of study close-out must be submitted to the Thai FDA within 60 days after the close-out of the last 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, Thailand

Relevant Sections: Ethical Review Committee for Research in Human Subjects Ministry of Public Health, Thailand (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 Section: 6.6

(2) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

Sponsorship > Definition of Sponsor
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SUMMARY

Overview
As specified in the G-ResEthics, the Thai government, which complies with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs), 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) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

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, Thailand

Relevant Section: 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 Section: Annex 5

Sponsorship > Trial Authorization
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SUMMARY

Overview
In accordance with the G-CTAppDrugImprt the ECReg&Proc, and Additional Resources (A) and (B), 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 and the G-CTAppDrugImprt, 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 (C)). In addition to the completed application, the sponsor or the CRO must also provide the ethics committee 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

(A) (Website) Global Health Technologies Coalition – Thailand: Drugs (Current as of September 26, 2014)
Global Health Technologies Coalition, Washington, DC

(B) (Website) Medicinal Product Regulation and Product Liability in Thailand: Overview (February 1, 2016)
Practical Law, London, UK

(C) (Form) Health Product Classification (NorYorMor1) Application Form (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health, Thailand

REQUIREMENTS

(1) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(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, Thailand

(3) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (September 2001)
Legal Affairs Group, Thai Food and Drug Administration, Ministry of Public Health, Thailand

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 Conference on Harmonisation (ICH) Harmonised Tripartite 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) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

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 Section: Annex 5 (8)

Sponsorship > Compensation
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SUMMARY

Overview
As specified in the G-ResEthics and the G-CTAppDrugImprt, 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)

(2) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

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 Conference on Harmonisation (ICH) Harmonised Tripartite 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 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 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 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.

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 G-CTAppDrugImprt also specifies that the Thai FDA must be notified no later than 30 working days after the date of discontinuance.

According to an in-country subject matter expert and the G-CTAppDrugImprt, notification of study close-out must also be submitted within 60 days after the close-out of the last site (the form template included in the G-CTAppDrugImprt with the details of remaining drug for return or destruction should be used.)

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) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Section: 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 (1, 5, 6, 19, 21, and 23)

(2) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

Sponsorship > Site/Investigator Selection
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SUMMARY

Overview
The G-ResEthics, which implements the International Conference on Harmonisation (ICH) Harmonised Tripartite 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) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Section: 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 Committee in Thailand, Thailand

Relevant Sections: Descriptions and Definitions, Appendix 3

Informed Consent > Documentation Requirements
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Last content review/update: July 19, 2017. Submit updates or comments.
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-CTAppDrugImprt and the G-ResEthics. As per the G-CTAppDrugImprt 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 G-CTAppDrugImprt 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-CTAppDrugImprt and the G-ResEthics also specify that the oral and written information concerning the trial, including the ICF, should be easy to understand and presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. The participant, and his/her legal representative(s) or guardian(s), should also be given adequate time to consider whether to participate.

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

Language Requirements
As stated in the G-CTAppDrugImprt, the ICF content should be presented in the language of the participants. All accompanying information, both oral and written, must be in Thai the language of the participants. According to an in-country subject matter expert and the G-CTAppDrugImprt, all documents must also be translated in Thai or English and certified by a qualified translator.

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, Thailand

Relevant Section: Information Sheet (p.70)

REQUIREMENTS

(1) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(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, 3.1, 3.2, and 3.3

Informed Consent > Required Elements
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SUMMARY

Overview
As delineated in the G-CTAppDrugImprt 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 G-CTAppDrugImprt 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 Population 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, Thailand

Relevant Section: Information Sheet (p.70)

REQUIREMENTS

(1) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(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 G-CTAppDrugImprt 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 G-CTAppDrugImprt 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

No additional resources

REQUIREMENTS

(1) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015) 
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(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 G-CTAppDrugImprt 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 G-CTAppDrugImprt 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 G-CTAppDrugImprt 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 G-CTAppDrugImprt 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 G-CTAppDrugImprt 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

No additional resources

REQUIREMENTS

(1) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(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, 3.1, 3.2, 3.3, and 4.1

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

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, 3.3, 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

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 > 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 ECsethics 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, Thailand

Relevant Section: Additional Resolution of the Committee (2006) (p.77)

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

(2) (Regulation) Thailand Civil and Commercial Code (B. E. 2468) (ThaiCode – English, unofficial version) (January 1, 1925)

Relevant Sections: Part II (Sections 19 and 20)

Informed Consent > Pregnant Women, Fetuses & Neonates
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Last content review/update: March 14, 2016. Submit updates or comments.
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

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 Section: 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 Conference on Harmonisation (ICH) Harmonised Tripartite 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 of four 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 G-CTAppDrugImprt, 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) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Section: 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 Section: 7.1 and Annex 5

(2) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (September 2001)
Legal Affairs Group, Thai Food and Drug Administration, Ministry of Public Health, Thailand

Relevant Sections: General Provisions (4)

(3) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

Investigational Products > Manufacturing & Import
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Last content review/update: June 07, 2017. Submit updates or comments.
SUMMARY

Overview
According to the G-CTAppDrugImprt, the BE2510Amdmts, and Additional Resources (A), (B), (C), and (D), 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 (E) 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 G-CTAppDrugImprt, the BE2510Amdmts, Additional Resource (C), and an in-country subject matter expert, 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.

According to an in-country subject matter expert and the G-CTAppDrugImprt, the import permit will be expire 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.

In addition, according to an in-country subject expert and the G-CTAppDrugImprt, 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 G-CTAppDrugImprt for more detailed IP supply requirements.

ADDITIONAL RESOURCES

(A) (Website) Food and Drug Administration Thailand – Pre-Marketing Control – Licensing (Current as of March 2, 2017)
Thai Food and Drug Administration, Ministry of Public Health, Thailand

(B) (Presentation) Drug Control and Registration (2010)
Siriporn Chawanon, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health

(C) (Website) Global Health Technologies Coalition – Thailand: Drugs (Current as of September 26, 2014)
Global Health Technologies Coalition, Washington, DC

(D) (Website) Medicinal Product Regulation and Product Liability in Thailand: Overview (February 1, 2016)
Practical Law, London, UK

(E) (Form) Health Product Classification (NorYorMor1) Application Form (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health, Thailand

REQUIREMENTS

(1) Drug Act B.E.2510 (A.C. 1967) and its Amendments ((BE2510Amdmts) (September 2001)
Legal Affairs Group, Thai Food and Drug Administration, Ministry of Public Health, Thailand

Relevant Sections: Chapter I (10), Chapter II (12), Chapter III (25 and 27), and Chapter V (46)

(2) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

Investigational Products > IMP/IND Quality Requirements
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SUMMARY

Overview
In accordance with the G-CTAppDrugImprt and 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, the Thai government, which complies with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs), specifies that the IB must 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.

As defined in the G-ResEthics, the sponsor is also accountable for supplying the IP, including the comparator(s) and placebo, if applicable. Additional Resource (C) also specifies that the sponsor must ensure that the products are manufactured in accordance with the current codes of Good Manufacturing Practice (GMP).

(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 G-CTAppDrugImprt, the BE2510Amdmts, and Additional Resource (C), 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) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Section: 7

REQUIREMENTS

(1) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(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 (6.2, 12.2, and 13)

(3) Drug Act B.E.2510 (A.C. 1967) and its Amendments (BE2510Amdmts) (September 2001)
Legal Affairs Group,  Thai Food and Drug Administration, Ministry of Public Health, Thailand

Relevant Section: Chapter III (25)

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 G-CTAppDrugImprt and the G-ResEthics. The G-ResEthics states that the IP must be coded and labeled in a manner that protects blinding, if applicable. The G-CTAppDrugImprt specifies that the drug labels must include the following information:

  • Non-proprietary or common name of drug product and strength(s)
  • Trial number and/or trial title
  • Batch number
  • Sponsor name and address
  • Expiration or retest date
  • Storage conditions

According to an in-country subject matter expert and the G-CTAppDrugImprt, the label or picture of the label of all containers must also be similar to the real label. Further, in the case that participants must take home and self-administer a study drug, the label must be in Thai or the language understood by the study participants. In case relabeling or additional labeling is needed after importing the drug into Thailand, the procedure/record/review and quality control of the labeling must be able to be inspected. If additional labeling is needed, this information must be included in the application when submitting the NorYorMor1 application form. This approval must be obtained before implementation, and the approximate time for review is 15 days.

In addition, if the drug is registered in a foreign country, the package insert in that country is also required. If the package insert is not in English, it needs to be translated into Thai or English with a certification. Please refer to the G-CTAppDrugImprt (in Thai for additional information.

ADDITIONAL RESOURCES

(A) (Form) Health Product Classification (NorYorMor1) Application Form (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health, Thailand

REQUIREMENTS

(1) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(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 Section: Annex 5 (13.1)

Investigational Products > Product Management
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Last content review/update: July 19, 2017. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-CTAppDrugImprt and 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) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CTAppDrugImprt – Thai and English) (August 13, 2015) (Effective Date: August 18, 2015)
International Affairs and Investigational New Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

Relevant Sections: 3 and 10

(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 Section: Annex 5 (5.11, 6.2, 13 and 14)

Specimens > Definition of Specimen
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Last content review/update: March 15, 2016. 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: July 19, 2017. Submit updates or comments.
SUMMARY

Overview
According to Additional Resources (A), (B), (C), and (D), 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 (E) 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) Food and Drug Administration Thailand – Laws and Regulations (Current as of March 2, 2017)
Thai Food and Drug Administration, Ministry of Public Health, Thailand

(B) (Website) Medicinal Product Regulation and Product Liability in Thailand: Overview (February 1, 2016)
Practical Law, London, UK

(C) (Website) Global Health Technologies Coalition – Thailand: Drugs (Current as of September 26, 2014)
Global Health Technologies Coalition, Washington, DC

(D) (Presentation) Drug Control and Registration (2010)
Siriporn Chawanon, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health, Thailand

(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, Thailand

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) (September 2001)
Legal Affairs Group, Food and Drug Administration, Ministry of Public Health, Thailand

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: March 15, 2016. 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 Section: 3.1.1, 7.5, 7.6, and 7.7

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OMB #: 0925-0668
Expiration Date: 2/28/2019