Among 10 ASEAN countries, Thailand registers the highest number of clinical trials in the region, and the number of BA/BE studies is increasing. An interest in understanding the regulatory and approval process in Thailand is expected for being such a preferred destination to conduct clinical trials.
Continuation from Thailand’s Clinical Trial Regulatory Scenario – Simplified (1/2).
We receive queries, often from pharmaceutical companies and clinical research organizations, asking about the approval processes involved and the time for such approvals.
Ethics Committee (EC) approval timelines
This is the most interesting part of the Thailand clinical trial regulatory scenario – timelines for approval. It varies so greatly among all parties, and even for a particular agency, expected timelines can not always be, well, expected. But the good news is there are average or median timelines available from experience / latest updates, which one can use for their project planning.
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Check out below given timelines and feel free to use them in your planning. They’re updated periodically.
|Ethics Committee||Expected timelines for approval||Remarks|
|EC – MOPH||3 – 9 months||Yes, it can be that long! It’s the busiest EC with lots of applications submitted every month.|
|IHRP||6 – 10 weeks||Like it? Many do. Sad, it’s not completely active now.|
|CREC||2 – 4 months||It’s getting better and has steadily replaced the gap left by IHRP. Thai FDA encourages the work of CREC for MRCT (multi-regional clinical trials). In that sense, it recommends applying to CREC for MRCTs.|
|Other recognized ECs||1 – 3 months||Varies for each site, but most of them approve within 4-6 weeks.|
|Local ECs||1 – 2 months||–|
Import Permit from FDA
- In parallel with submission to a recognized EC, the applicant can apply for the import permit. In fact, since Oct 2016, Thai FDA has accepted parallel submission with recognized ECs.
- FDA has recently made some changes in the import permit process, and this streamlined system has some additional activities to be performed. Now, an additional license per invoice (LPI) is necessary for each shipment.
Documents required for approval
Parallel to the recognized EC, the applicant shall apply to the FDA in the prescribed format. In addition to the import license application form and EC approval letter, a letter of authorization for the local importer is also necessary.
Timelines for approval
It takes about 2 – 3 months for approval. Although approval for chemical and biological drugs claims 20 and 60 working days, many projects may experience delays.
The timelines start afresh for Import Permit renewal applications, so, it’s a good idea to be careful about planning. 🙂
Fees for approval
The charges for the import permit application – the approval process is about THB 5000 (~ USD 160).
Additional step – LPI
- The applicant shall carefully consider before applying for an import license due to the recent changes made in the process. And now, in addition to securing the import permit, each drug import requires approval through an electronic system. Absence of such a license, drugs will get stuck at the customs. 🙁
- The documents required for LPI are similar to the import permit, while some additional documents like a certificate of analysis are also necessary. It’s also strongly advised to check the information provided in documents for accuracy. Any wrong information may lead to custom restraint and additional expenses.
- Considering the above details, it is notable that the Thai FDA reviews the Import Permit periodically so, one may also want to check with the Thai FDA before application.
Get in Touch with your regulatory requirement in Thailand
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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
Disclaimer: Information provided here is not being claimed as official. The applicant is strongly advised to check the recent requirements with relevant authorities.