Thailand FDA periodically releases a list of institutional review boards (IRBs) / ethics committees (ECs) that it recognizes for acceptance of clinical trials. Under Thailand regulatory system, approved ethics committees serve as the main point of approvals for initiating clinical trials in the country.

This has been explained in our previous articles (see Part I and Part II), wherein we discussed a regulatory scenario in Thailand, including regulatory approvals for the clinical trial in Thailand, ethics committee approval for the clinical trial in Thailand, documents required for regulatory submission, and ethics committee submission in Thailand.

We’d presented a list of ethics committees that are recognized for application to the Thailand FDA. Updates to this list were further reported in another article (see the previous update on Thailand’s approved IRBs).

The current article presents and discusses a list of IRBs as reported on the Thailand FDA website. This link provides details in the Thai language, but the below sections give this list in English for others to understand. [Note: Below given list is an approx translation. You’re advised to use accredited translators before using the below information.]

List of Ethics Committees recognized by FDA Thailand

S# (Number as per the list on Thai FDA website)Name of IRB, or name of institute / Hospital / University, where IRB is establishedRecognition starts fromRecognition end on
1 (1/2016)Bangkok Hospital, Bangkok07 Oct 201606 Oct 2018
2 (2/2016)Phramongkutklao Collage of Medicine, Bangkok05 Oct 201604 Oct 2018
3 (3/2016)IHRP, Bangkok07 Oct 201606 Oct 2018
4 (4/2016)Bumrungrad Hospital, Bangkok07 Oct 201606 Oct 2018
5 (5/2016)Khon Kaen University, Khon Kaen11 Nov 201610 Nov 2018
6 (6/2016)Siriraj Hospital, Mahidol University, Bangkok24 Nov 201623 Nov 2018
7 (7/2016))Mahidol University’s Center of Ethical Reinforcement for Human Research, Bangkok29 Nov 201628 Nov 2018
8 (8/2016)Ramathibodhi Hospital, Bangkok07 Dec 201606 Dec 2018
9 (9/2016)MOPH IRB, Bangkok06 Dec 201605 Dec 2018
10 (10/2016)CREC, Bangkok07 Dec 201606 Dec 2018
11 (1/2017)Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok25 Jan 201724 Jan 2019
12 (2/2017)Faculty of Medicine, Chulalongkorn University, Bangkok20 Jan 201719 Jan 2019
13 (3/2017)Faculty of Medicine, Prince of Songkla University, Hat Yai25 Jan 201724 Jan 2019
14 (4/2017)Faculty of Tropical Medicine, Mahidol University, Bangkok20 Jan 201719 Jan 2019
15 (5/2017)Faculty of Medicine, Chiang Mai University, Chiang Mai25 Jan 201724 Jan 2019
16 (6/2017)Faculty of Medicine, Thammasat University, Pathum Thani17 Mar 201716 Mar 2019
17 (7/2017)Research Institute of Health and Environment Sciences, Chiang Mai University, Chiang Mai1 Jun 201731 May 2019
18 (8/2017)Department of Thai Medicine and Alternative Medicine5 Jul 20174 Jul 2019
19 (9/2017)Bamrasnaradura Infectious Disease Institute, Nonthaburi24 Aug 201723 Aug 2019
20 (10/2017)Naresuan University, Phitsanulok29 Aug 201728 Aug 2019

Important updates in the new list

The current list has some important points to note.

  • The first 10 ethics committees on the list are actually from the list approved earlier (reported here).
  • Most of the ethics committees in the remaining list are currently out of their approval period. (Though, it’s possible that FDA may be coming out with a newly approved list with extended approval periods.)
  • No more ethics committees (ECs) from private hospitals have been recognized by Thailand FDA. Earlier recognized private hospitals’ ECs were Bangkok Hospital and Bumrungrad Hospital.
  • Ethics committees, which are still under their valid approval period are
    1. Research Institute of Health and Environment Sciences, Chiang Mai University, Chiang Mai
    2. EC of Department of Thai Medicine and Alternative Medicine
    3. Bamrasnaradura Infectious Disease Institute, Nonthaburi
    4. Naresuan University, Pitsanulok
  • Govt. IECs/IRBs, including the MOPH ethics committee and, new one on the bloc – CREC are still continuing. Read more about CREC in our previous post.
  • IHRP has been included this time as well. This EC is continuing to accept BE study applications.
  • Naresuan University, which is continually being since the last two times, continues to be approved until 28 Aug 2019.

Impact of the new list of recognized ECs

Expired approval validity periods

Since most of the EC’s (including all traditional ones) are out of their validity period, further updates on the list from the Thai FDA will be keenly awaited. This list will help in providing validity to scores of clinical trials approved by such ethics committees.

CREC

As discussed in our previous article, this new central ethics committee is one of the best things that happened to the Thailand clinical trial scene in the last few years. It’s recognized by FDA, affiliated to several sites in Thailand, and still not heavily loaded with clinical trial applications. This means shorter queues for submission, quicker approval times, and, best of all, flexibility to work at several excellent sites in Thailand.

Saving time…and cost!

If a site is not affiliated with an EC that has been recognized by Thailand FDA, then mostly investigator needs to apply to two ECs for approval. Local EC and central EC (recognized by FDA). In such cases, there may be a delay in project approval due to the submission queue at the central EC office. It means that an additional time period of 3-9 months may have to be factored in planning.

However, if a trial has been planned at a site that is affiliated with an FDA-recognized EC, then the trial team can save a lot of time in securing necessary EC approval, as well as cost required for such planning, execution, and management.

Trial managers, do factor these sites in your project planning. 🙂


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