2. General Questions

2.1 Name of Regulatory Authority

In Thailand, drugs, medical devices, food, narcotics, cosmetics, and hazardous substances are regulated by the Thai Food and Drug Administration. 

https://en.fda.moph.go.th/

2.2 Name of Ethics Committee 

Thailand operates a central ethics committee as well as 20 private hospital/institutional ECs. These committees are approved by the Thai FDA.

The list of human ethics committees is supplied in this translated document:

https://credevo.com/articles/2019/03/27/update-2-thailands-latest-approved-irb-list/

https://credevo.com/articles/2016/09/12/clinical-trial-regulatory-approval-process-in-thailand-1/#:~:text=In%20Thailand%2C%20Ethics%20Committee%20approval,the%20FDA%2Drecognized%20ethics%20committee 

2.3 Clinical Trial Application Language

The clinical trial documentation should be submitted in a mixture of Thai and English as outlined below:

• The packaging and labeling information should be presented in Thai or English.
• The protocol synopsis must be submitted in Thai.
• The detailed study protocol specification (completed version of the study protocol) may be in Thai or English.
• The patient information sheet must be in Thai.
• Drug labels of all sizes in Thai or English.
• The Certificate of Free Sale must also be presented in English and translated by a trusted certification authority and any other language in which it has been originally issued.
• The progress report must be submitted in Thai.

2.4 Is regulatory approval required from both regulatory authorities and/or EC? 

In Thailand, Ethics Committee approval is the primary requirement to conduct clinical trials because this serves the dual roles of regulatory authority and ethics committee approval.

https://credevo.com/articles/2016/09/12/clinical-trial-regulatory-approval-process-in-thailand-1/#:~:text=In%20Thailand%2C%20Ethics%20Committee%20approval,the%20FDA%2Drecognized%20ethics%20committee.

2.5 Can regulatory authority and EC submission be done in parallel?

As above, approval is only required from the Ethics Committee.

2.6 Requirement of any import permit/license before investigational product/study product is shipped from point of origin

The Thai FDA is responsible for issuing import permits for any investigational products to be used in clinical trials. The import permit can only be approved following the Ethics Committee's approval of the trial.

2.7 Biological Specimen Export Requirements

The requirements for the transport of biological specimens are defined in The Ethical Guidelines for Research in Human Subjects in Thailand (2007). A template for the Material Transfer Agreement (MTA) is provided in Annex 8 of the guidance.

http://www.fercit.org/file/Guideline_English_version.pdf

2.8 Are studies of GMOs permitted (e.g., GMOs used in vaccines/vaccine manufacture and other modified products)?

Yes, subject to EC approval.

2.9 Is In-country sponsor presence/representation required?

No, the sponsors of the clinical trial are not required to be in Thailand but a sponsor may elect to delegate this responsibility to a local representative. The responsibilities of the local representative are determined by the authority given to it by the sponsor.

Baker McKenzie Clinical Trial Handbook

2.10 Is there any mandatory requirement to identify a local PI or can a PI be based in a foreign country?

No, there are no specific legal requirements governing the investigators of clinical trials in Thailand.

Baker McKenzie Clinical Trial Handbook

2.11 Is there any mandatory requirement to identify a local chief or coordinating investigator?

No, see above.

2.12 If the applicant is CRO or a third party, does regulatory authority need any authorization or transfer of obligations from the sponsor? Does the authorization letter need to be notarized and/or apostilled?

There is no set template for the transfer of obligations from the sponsor.

2.13 Is there a requirement to register clinical trials on a local registry or database?

Yes, the Thai Clinical Trials Registry (TCTR) encourages all clinical trials conducted to be registered before the subject recruitment.

https://www.thaiclinicaltrials.org/

2.14 What is the local requirement for clinical study documents archival; minimum of years for the archival, specific format followed (electronic/paper and/or both)?

Sponsors should retain study documentation (either in electronic or paper format) for at least two years post the last marketing approval or two years post-study termination.

2.15 Requirements around periodic safety reporting and timelines on SAEs/AEs/ADRs/SUSARs/DSURs.

Thailand adheres to the ICH requirements on Good Clinical Practice for Safety Reporting (ICH E6 (R2)).

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 became aware of the event. The PI must also report all AEs/ADRs to the sponsor and the EC no later than seven calendar days following first knowledge.

https://clinregs.niaid.nih.gov/country/thailand#safety_reporting

2.16 Requirement on any periodic clinical study update, specific template, and its frequency (e.g., interim, or annual progress report and final report, etc.)? 

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

The sponsor must submit a study progress report annually to the Thai Food and Drug Administration (Thai FDA) between October 1 and 31 every year until the study ends.

In the event of the early termination of the research study, the sponsor must submit a summary report to the Thai FDA within 60 days after the closeout of the last study site. Investigator(s) to submit a final report to the EC upon the trial’s termination.

https://clinregs.niaid.nih.gov/country/thailand#progress_reporting

2.17 Does the local regulation require notification of “serious breaches” of GCP or the trial protocol?

Yes, sponsors are required to notify the EC of any serious breaches of GCP.

2.18 Does RA/CA require insurance and indemnity to cover the sponsor and investigator’s potential liability?

Yes, according to The Ethical Guidelines for Research in Human Subjects in Thailand (2007), the sponsor should indemnify the investigator/institution against claims arising from the trial.