Clinical trial approval process in thailand

Documents required for approval Parallel to the recognized EC, the applicant shall apply to the FDA in the prescribed format. Timelines for approval It takes about 2 — 3 months for approval. 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. Any wrong information may lead to custom restraint and additional expenses. Get in Touch with your regulatory requirement in Thailand Provide preliminary details below Please enable JavaScript in your browser to complete this form. Provide your comments, or details of your requirements.

What is your work email? Request A Quote. The same Company shall be responsible for any damage caused by the device and shall certify the disposal or the re-export of the tested equipment.

The Agreement must report in detail the scope of the research, the medical device used and many other details. After your MOU has been signed and you gave us your POA, we will collect all the documentation and prepare a file that can be used multiple times for different Temporary Import License for your Medical Device but every time we must get a new authorization from Thai FDA! After the submission, in a straightforward case the Import Authorization will be issued within 14 days.

Further documentation may be asked by FDA. After the medical device has been used for testing, it must be sent to the origin or disposed by an accredited company,. Siam Trade Development will be your Authorized Importer by Power of Attorney and will work in strict connection with your chosen institute for Trials.

Read more about CREC in our previous post. IHRP has been included this time as well, however, currently, there are no new applications being accepted there, as reported by some of our industry contacts. Naresuan University, which was included in the last modification, continues to be approved until 9 Apr Its further continuation in this list may be decided later on. University and Govt. Need support for conducting your clinical trials in Thailand? Impact of a new list of recognized ECs Private hospitals There is no doubt that some trial management teams find it more convenient if their clinical sites are at private hospitals.

Central Research 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. Saving time…and cost! Connect with Thailand consultants You can make the most of these advantages if you have a trial team based in Thailand.

Do you need any support for your clinical development process in Thailand? Provide your requirement details below to talk with us. Please enable JavaScript in your browser to complete this form.