Among 10 ASEAN countries, Thailand registers the highest number of clinical trials in the region, and the number of BA/BE studies is increasing. Many pharmaceutical companies are interested to understand the regulatory process and requirements to conduct their clinical trials in Thailand.
We receive queries, often from pharmaceutical companies and clinical research organizations, asking about the approval processes involved and the time for such approvals.
Here is a crisp summary of a general regulatory scenario for one who intends to conduct clinical studies.
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Clinical Trial Regulatory Scenario & Approval in Thailand
- Approval for clinical trials in Thailand
- Ethics Committee approval
- Which EC?
- Ethics committee – MOPH
- Local ECs
- Timelines for EC approval
- Which EC?
- Import Permit from FDA
- Documents required
- Timeframe for approval
- Additional step – LPI
Approval for clinical trials in Thailand
There are two main kinds of approvals required in Thailand.
- The first one is the Ethics Committee’s approval for the protocol.
- Second is the Thailand FDA approval for Import Permits.
Ethics Committee approval & FDA approval
- 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.
- The sponsor can conduct a clinical trial after receiving approval from the FDA-recognized ethics committee. Sounds simple? Well, not so much. Here is why.
- Thailand FDA has recognized 11 ethics committees. Thai FDA considers review from one of these ethics committees while reviewing the application for an import permit.
- Click here to know about Thailand’s latest approved IRB list.
- That means, if your clinical trial has approval from an ethics committee, not from this list, then you’ll need to go for another EC application to one of the FDA-recognized ethics committees.
- Every EC has its own set of requirements and processes.
- The sponsor needs to follow all steps for timely approval.
Which Ethics Committee for clinical trials in Thailand?
The recognized ECs list includes three centrally formed ECs and 8 ECs from universities and hospitals. It’s to expect that the ECs from universities and hospitals accept the applications only for in-house studies, irrespective of the sites.
It means if your clinical trial is being undertaken at a site, not from these eight universities and hospitals, then you need to go to central ECs, which has its issues (discussed later). No wonder almost all of these eight universities and hospital sites are the most actively engaged in clinical trials in Thailand.
Coming back to Ethics Committee, the three central ECs are
Ethics Committee – MOPH
- Most of the clinical trials in Thailand apply for the Ministry Of Public Health (MOPH) – run ethics committee.
- The process and requirements of the application are simple and straightforward. These are present on their website. [Unfortunately, it’s in the Thai language. I’ll try to share more information on them in another blog later.]
- Irrespective of any clinical trial site, you can apply to this EC for every trial (of course, except if the clinical trial involves any of ‘those’ eight universities and hospitals, then you need to apply to their EC as well).
- Due to this, the number of applications per month is high, and the approval times are longer than other ECs.
Institute for the development of Human Research Protections (IHRP)
- Institute for development of Human Research Protections (IHRP) is an Ethics Committee and works under the Department of Medical Sciences, Ministry of Public Health. However, it’s different from and should not be confused with the previously mentioned EC.
- For quite a long time, this EC, with fast approval timelines, has been a favorite of the clinical trial industry. Unfortunately, it’s only partially active now.
- It was discontinued more than two years back and resumed activities after several months. Since then, it’s accepted applications for only some studies, mostly BA/BE studies.
- One can stay updated about it on their website. [Again, the website is in the Thai language, and I’ll try to include more details on it in next blog].
Central Research Ethics Committee (CREC)
Central Research Ethics Committee (CREC) is the latest entrant in this league. It was introduced in August 2014 to bring a much-needed change in the regulatory scenario in Thailand.
It is 26 institutes, departments, hospitals, and universities collaboration. Thailand FDA is one of the collaborators, also recognizes this new EC.
CREC composes of a joint committee from various institutions. It accepts applications from all collaborating and other affiliated parties. That effectively covers all the sites commonly useful for clinical trials in Thailand. Still, in the growing phase and not much experienced, CREC will take some time to gain expertise to handle many applications, which are regularly increasing.
It certainly provides some advantages, like a single review of multi-center studies. That results in a faster approval timeline since it is a single review for a multi-center clinical trial (one submission/per study). They even promote through online submission. Try their website. (For those, who are not very comfortable with Thai content, I’ll try to provide more details in another blog). The other 8 ECs from universities and affiliated hospitals belong to the following sites.
- Faculty of Tropical Medicine, Mahidol University, Bangkok
- Siriraj Hospital, Bangkok
- Faculty of Medicine, Chiang Mai University, Chiang Mai
- Ramathibodhi Hospital, Bangkok
- Faculty of Medicine, Prince of Songkla University, Hat Yai
- Faculty of Medicine, Khon Kaen University, Khon Kaen
- Phramongkutklao Collage of Medicine, Bangkok
- Faculty of Medicine, Chulalongkorn University, Bangkok
Local Ethics Committee’s
Although FDA does not recognize any of the above given eight university sites still approval from them becomes practically necessary to perform a clinical trial. The sponsor can apply in parallel to the central EC approval.
If the sponsor has the central EC approval, it can help as a supporting document.
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We invite you to continue reading: Clinical Trial Regulatory & Approval Process In Thailand (Part-2)
Click the following links for more information
- Latest updates on Clinical Trial Regulatory Scenario in Thailand
- Thailand’s Latest Approved IRB List
- Marketing Authorization & Regulatory Requirements for Drug Registration in Thailand