Continued from Thailand’s Clinical Trial Regulatory Scenario – Simplified (1/2)

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.

2.2 Timelines for EC approval
3 Import Permit from FDA
3.1 Documents required
3.2 Timeframe for approval
3.3 Fees
3.4 Additional step – LPI

Timelines for EC approval

This is the most interesting part of the Thailand’s clinical trial regulatory scenario – expected timelines for approval. It varies so greatly among all parties and, even for a particular agency, expected timelines can’t always be, well, expected. But, good news is there are average or median timelines available from experience / latest updates, which one can use for their project planning.

Check out below given timelines and feel free to use them in your planning. They’re updated as per the latest update (July 2015).

 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? Me too. Sad, it’s not completely active now.
CREC 2 – 4 months It’s getting better and may steadily replace the gap left by IHRP.
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

  • Importing the study drugs and lab kits in Thailand requires approval from FDA. This approval can be applied for, after getting EC approval from a recognized EC. In that sense, it’s a serial approval system.
  • FDA has recently brought some changes in the import permit process, which although have streamlined the system; have also added some additional activities to be performed. Now, an additional license per invoice (LPI) is required for each shipment.

Documents required

After approval from a recognized EC, application in the prescribed format is submitted to FDA. In addition to import license application form and EC approval letter, an authorization letter for the local importer is also required. All required documents can be listed as

  • Application form for import permit
  • EC approval letter
  • Location importer’s authorization
  • Protocol
  • Investigator brochure
  • Informed consent form
  • Package Insert
  • Label (Thai – necessary, English – optional)
  • Quantity estimation for import. Note: Applicant is free to request for overages (not more than 20%) in the application.
  • Proforma invoice (from the exporter abroad)
  • Timeframe for approval

The approval is reported to be given in about 2-3 months. Although, 20 and 60 working days are claimed for chemical and biological drugs respectively, many projects may experience delays.

If import permit is to be renewed, then the timelines start afresh. So, it’s a good idea to be careful in planning. 🙂
Fees

The charges for import permit application – approval process is about THB 25000 (~ USD 700).

Additional step – LPI

  • Recently introduced steps should be carefully considered while applying for import license. Now, in addition to securing the import permit, each import of drugs will have to be additionally approved through an electronic system. In absence of such license, drugs will get stuck at the customs. 🙁
  • The documents required for LPI are similar to import permit, while some additional documents like certificate of analysis will also be required. It’s also strongly advised to check information provided in documents for accuracy. Any wrong information may lead to custom restraint and additional expenses.
  • Having considered above details, it’s worth noting that the process of import permit is still being reported to be under review by Thai FDA. So, expect some changes soon. One may also want to check with Thai FDA before application.

Any comments or questions related to this post are welcome. Please send an email to info@credevo.com or contact us.

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

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