Clinical trial regulatory and approval process in Thailand

Thailand furnishes a good infrastructure, a robust and flexible regulatory process to conduct clinical trials. There is a rise in the interest of many pharma companies and research organizations in conducting clinical trials in Thailand.

Clinical trial regulatory and approval process in Thailand

Continuation from Clinical Trial Regulatory & Approval Process In Thailand (Part-1).

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

Clinical trial approval timelines are the most interesting part of the Thailand clinical trial regulatory scenario. 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 CommitteeExpected timelines for approvalRemarks
EC – MOPH3 – 9 monthsYes, it can be that long! It’s the busiest EC with lots of applications submitted every month.
IHRP6 – 10 weeksLike it? Many do. Sad, it’s not completely active now.
CREC 2 – 4 monthsIt’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 monthsVaries for each site, but most of them approve within 4-6 weeks.
Local ECs1 – 2 months

Import Permit from FDA

  • In parallel with submission to a recognized EC, the applicant can apply for an import permit. In fact, since Oct 2016, the Thai FDA has accepted parallel submissions 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 takes 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 customs. 
  • The documents required for LPI are similar to the import permit, while 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.

Any comments or questions related to this post are welcome. Please send an email to [email protected] or contact us.

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Disclaimer: Information provided here is not being claimed as official. The applicant is strongly advised to check the recent requirements with relevant authorities.

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