There is an increasing interest in the conduct of clinical trials in Thailand and other ASEAN countries. Know more about Potential with Clinical Trial Sites in Asia & West.
Among 10 ASEAN countries, Thailand has registered highest number of clinical trials in the region. Moreover, increasingly greater number of BA/BE studies are being performed for Thailand submission. Being such preferred destination to conduct clinical trials, interest in understanding regulatory process involved is quite expected.
We receive queries often from pharmaceutical companies and clinical research organizations asking about the approvals needed, processes involved and time taken to obtain such approvals.
Here is a crisp summary of what a general regulatory scenario will be, when one intends to conduct clinical studies in Thailand. Click here for more Regulatory details and updates in Thailand
1 Number of approvals needed
2 Ethics Committee approval
2.1 Which EC?
2.1.1 1. Ethics committee – MOPH
2.1.2 2. IHRP
2.1.3 3. CREC
2.1.4 Local ECs
2.2 Timelines for EC approval
3 Import Permit from FDA
3.1 Documents required
3.2 Timeframe for approval
3.4 Additional step – LPI
Number of approvals needed
There are two main kinds of approvals required in Thailand. The first one is the Ethics Committee approval for protocol. Second is the Thailand FDA approval for import permit.
Ethics Committee approval & FDA approval
- In Thailand, Ethics Committee approval is the primary approval requirement for conduct of the clinical trials. Thus, this actually serves the dual roles of regulatory authority and ethics committee approval.
- If a clinical trial has obtained approval from a FDA-recognized ethics committee, then it is allowed to be conducted in Thailand. Sounds simple? Well, it’s not so much. Here is why.
- Thailand FDA has recognized 11 ethics committees as the ones whose approval they’ll consider while reviewing the application for import permit. Click here to know about Thailand’s Latest Approved IRB List
- This 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, which, although fairly simple, differ from each other. These are needed to be closely followed to secure timely approval.
This list of recognized ECs includes 3 centrally formed ECs and 8 ECs from universities and hospitals. As expected, ECs from universities and hospitals accept the applications only for studies, which being conducted in-house. However, centrally formed ECs accept all studies, irrespective of the sites involved.
This means, if your clinical trial is being undertaken at a site not from these 8 universities and hospitals, then you need to go to central ECs, which has its own issues (discussed later). No wonder, almost all of these 8 universities and hospital sites are the ones most actively engaged in clinical trials in Thailand.
Coming back to ECs, the 3 central ECs are
1. ETHICS COMMITTEE – MOPH
- Ministry Of Public Health (MOPH) – run ethics committee is the one that has been and continues to be applied for most of the clinical trials in Thailand.
- The process and requirements of application are simple and straightforward. These have been given on their website. [Unfortunately, it’s completely in Thai language. I’ll try to share more information on them in another blog later.]
- Irrespective of any site involved, you can apply to this EC for every trial (of course, except if trial involves any of ‘those’ 8 universities and hospitals, then you need to apply to their EC as well). Due to this, the number of applications per month is quite high and the approval times are longer than other ECs.
- Institute for the development of Human Research Protections (IHRP) is actually an EC and works under the umbrella of Department of Medical Sciences, Ministry of Public Health. However, it’s different from and should not be confused with previously mentioned EC.
- For quite long time, this EC, with fast approval timelines, has been a favorite of clinical trial industry. Unfortunately, it’s only partially active now.
- It was discontinued about more than 2 years back and resumed activities after several months. Since then, it’s been accepting applications for only some studies, mostly BA/BE studies. One can stay updated about it on their website. [Again, website is in Thai language and I’ll try to include more details on it in another blog]
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 has been formed by collaboration among 26 institutes, departments, hospitals and universities in Thailand. Thailand FDA, being 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. This effectively covers all the sites commonly useful for clinical trials in Thailand. Still in growing phase and not much experienced, CREC will take some time to gain expertise in handling many applications, which are increasing regularly.
It certainly provides some advantages, like a single review of multi-center studies. This results in faster approval timeline, since it is a single review for multi-center study (one submission / per study). They even promote online submission. Try their website. [For those, not very comfortable with Thai contents, I’ll try to provide more details in another blog.]
Other 8 ECs from universities and affiliated hospitals are those belonging to following sites.
- Siriraj Hospital, Bangkok
- Ramathibodhi Hospital, Bangkok
- Faculty of Tropical Medicine, Mahidol University, Bangkok
- Faculty of Medicine, Chiang Mai University, Chiang Mai
- Faculty of Medicine, Prince of Songkla University, Hat Yai
- Faculty of Medicine, Khon Kaen University, Khon Kaen
- Faculty of Medicine, Chulalongkorn University, Bangkok
- Phramongkutklao College of Medicine, Bangkok
A mention is required for local ECs that are present in many sites other than above given 8 university sites. Although, none of them are recognized by FDA, still getting approval from them becomes practically necessary to perform a clinical trial in that site. This approval can be sought in parallel to the central EC approval. If central EC approval is obtained earlier, it can be submitted as a supporting document (it really helps!).
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We invite you to continue reading: Part 2 Thailand’s Clinical Trial Regulatory Scenario – Simplified (2/2)
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