{"id":35,"date":"2016-09-26T10:39:55","date_gmt":"2016-09-26T02:39:55","guid":{"rendered":"https:\/\/credevo.com\/articles\/\/?p=35"},"modified":"2024-10-12T14:36:01","modified_gmt":"2024-10-12T06:36:01","slug":"clinical-trial-regulatory-approval-process-in-thailand-2","status":"publish","type":"post","link":"https:\/\/credevo.com\/articles\/2016\/09\/26\/clinical-trial-regulatory-approval-process-in-thailand-2\/","title":{"rendered":"Clinical Trial Regulatory & Approval Process In Thailand (Part-2)"},"content":{"rendered":"\n

Thailand furnishes a good infrastructure, and 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.<\/p>\n\n\n\n

\"Clinical<\/figure>\n\n\n\n

Continuation from Clinical Trial Regulatory & Approval Process In Thailand (Part-1)<\/a>.<\/p>\n\n\n\n

We often receive queries from pharmaceutical companies and clinical research organizations asking about the approval processes involved and the time for such approvals.<\/p>\n\n\n\n

Ethics Committee (EC) approval timelines<\/h3>\n\n\n\n

Clinical trial approval timelines are the most interesting part of the Thailand clinical trial regulatory scenario<\/a>. 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.<\/p>\n\n\n\n

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Need support for conducting your clinical trials in Thailand?<\/h2>

Credevo offers expertise in drug product registration, clinical trial regulations, and many more services in Thailand. Provide the details of your requirements below to connect with us<\/a>.<\/p><\/blockquote>\n\n\n\n

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Check out given timelines below and feel free to use them in your planning. They’re updated periodically.<\/p>\n\n\n\n

Ethics Committee<\/strong><\/td>Expected timelines for approval<\/strong><\/td>Remarks<\/strong><\/td><\/tr>
EC \u2013 MOPH<\/strong><\/td>3 \u2013 9 months<\/td>Yes, it can be that long! It\u2019s the busiest EC with lots of applications submitted every month.<\/td><\/tr>
IHRP<\/strong><\/td>6 \u2013 10 weeks<\/td>Like it? Many do. Sad, it\u2019s not completely active now.<\/td><\/tr>
CREC <\/strong><\/td>2 \u2013 4 months<\/td>It\u2019s 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.<\/td><\/tr>
Other recognized ECs <\/strong><\/td>1 \u2013 3 months<\/td>Varies for each site, but most of them approve within 4-6 weeks.<\/td><\/tr>
Local ECs<\/strong><\/td>1 \u2013 2 months<\/td>–<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Import Permit from FDA<\/h2>\n\n\n\n