Preclinical and Clinical Trial Requirements
Key legal info on preclinical and clinical trial requirements in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
No, the clinical trial does not need to be conducted locally in order to obtain marketing approval. The Thai FDA only requests that clinical data be arranged in either the format of Part 4 of the ASEAN Common Technical Dossier (ACTD) or Module 5 of the ICH CTD.
2. Clinical trials are funded by sponsors (i.e., a drug companies, universities, hospital funds).
Clinical trials are funded by sponsors (i.e., a drug companies, universities, registered charitable organizations, hospital funds).
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
The Thai FDA will review and approve preclinical and clinical trial protocols when they receive an application for the approval of sample product importation. The requirements for conducting clinical trials are as follows:
- The applicant must first obtain ethics approval to conduct a clinical trial on humans from the Ethical Review Committee for Research in Human Subjects of the MOPH (ERC) and/or the ethics committee of the hospital, research institute or university that will conduct the trial. If approval is obtained from the ethics committee of the facility conducting the trial, approval from the ERC is usually optional.
- The applicant must ensure that the protocols of the trial comply with the guidelines for Good Clinical Practice (ICH/GCP) and Good Laboratory practice (ICH/GLP). The complete version of the trial protocols must be submitted to both the Thai FDA and the relevant ethics committee.
- The applicant must submit the package insert or summary of product characteristics, safety report, and progression report to the Thai FDA or the ethics committee. (if required).
4. What are the requirements for consent by participants in clinical trials?
Currently, there is no specific standalone legislation governing clinical trials in Thailand.
Nonetheless, consent is indirectly regulated by the Civil and Commercial Code, the National Health Act, B.E. 2550 (2007), the Mental Health Act, B.E. 2551 (2008), and the Personal Data Protection Act B.E. 2562 (2019).
As a typical practice of the GCP, trial subjects are required to sign an informed consent form before commencement of a clinical trial. The consent form must (1) provide information on how the data will be used, and (2) emphasize that participation is voluntary, meaning subjects have the right to withdraw from the trial at any time. A consent form must be signed and dated by the volunteer. In the event that a patient or volunteer cannot give consent on their own, consent can be provided on their behalf by their legal representative.
5. May participants in clinical trials be compensated?
Yes. Also, participants in clinical trials may be indemnified for any injuries or loss that may occur as a result of the clinical trial.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The sponsor of the clinical trial is held solely responsible for any injury or loss that may occur as a result of the study; not part of the responsibility is absorbed by the other partners or institutions performing the research. Although insurance is not always a mandatory requirement, the relevant ethics committee will always ask whether insurance is available for volunteers in the clinical trial.