4. Regulatory Authority (RA)/Competent Authority (CA)

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant. 

Sponsors must submit one original set and two copies of the following documents to the Thai Food and Drug Administration (Thai FDA):

1. Cover letter
2. Application for Permission to Import or Prescribe Drugs for Research Purposes in the Kingdom (Nor Yor Mor 1 form)
3. Checklists and attached documents for the above
4. Drug labels for every container (Thai or English)
5. Package inserts (for registered drugs)
6. Prescriptions (for registered drugs)
7. Investigator’s Brochure (IB) (for unregistered drugs)
8. Information Consent Certificate (Thai)
9. Patient Information Sheet (Thai)
10. Protocol synopsis (Thai)
11. A completed version of the study protocol (Thai or English)
12. Chemistry, manufacturing, and control (CMC) information
13. Ethics Committee (EC) approval from a Thai FDA-recognized institutionally-based EC and/or an independent EC. The EC review must be submitted to the Thai FDA no later than 15 days after the authorized person receives this decision.
14. Estimates of the amount of study drugs, comparators, or other goods to be imported
15. Certificate of Analysis
16. Certificate of Free Sale (English and other language used)
17. Drug registration authorization document
18. Summary of product characteristics
19. Literature review
20. Description (name and content) and pictures of lab/materials to be imported
21. Power of attorney
22. Investigational medicinal product (IMP) information

https://clinregs.niaid.nih.gov/country/thailand#regulatory_fees

4.2 Time required for RA/CA review and approval process and turnaround time if any query is raised during the review process. 

The Thai FDA’s review and approval process for drugs to be imported for clinical trials takes 20 working days upon receipt of the application. The Thai FDA review and approval process for biological medicines takes 60 days.

The Thai FDA coordinates the review of applications submitted to obtain drug import licenses for clinical trial purposes. Upon receipt of an application package, the Thai FDA’s One Stop Service & Consultation Center (OSSC) sends the application package to an officer in the Thai FDA’s International Affairs and Investigational New Drug Section. The officer then screens the package for completeness and informs the eligible sponsor of the results within five working days from the date the application is received. If deemed complete, the officer sends the package to the assigned technical reviewer to proceed. If the officer finds the package to be incomplete, then he/she will send a “Screening Result Notification form” to the applicant or his/her attorney for correction. If the applicant or his/her attorney fails to fully correct the package within five (5) working days, then the Thai FDA will send a rejection letter and return all the documents to the applicant. However, the applicant may later correct or amend the application package and resubmit it to the OSSC. Once the correction is completed, the officer will send the application package to the assigned reviewer to proceed.

The reviewer then receives the application package and performs a technical assessment. If he/she determines the package is technically correct, then the reviewer will forward the drug import license application for clinical trial purposes to the Thai FDA’s Secretary-General. If the reviewer finds the application package technically incorrect, then he/she will forward the application for rejection to the Thai FDA’s Secretary-General. If the reviewer finds the technical information to be incomplete, then he/she will request that the applicant or his/her attorney clarify and/or submit additional documents/information. If the documentation or amended information is not submitted within five working days, the Thai FDA will issue a rejection letter and return the package to the applicant. However, the applicant may resubmit a corrected package later. If the applicant can completely correct the application package within the required timeframe, the officer will forward the package to the assigned reviewer for re-assessment.

https://clinregs.niaid.nih.gov/country/thailand#timeline_of_review

4.3 Does the regulation support electronic submission?   

Yes, submission is via the Thai FDA’s One Stop Service & Consultation Center (OSSC) using the Skynet web portal.

4.4 Does the regulation require the applicant to be a Principal Investigator (PI)/Chief Investigator (CI)?

No, the applicant does not need to be a PI or CI.

4.5 Please describe the process of RA/CA submission for clinical trial approval.

The applicant must submit to the EC first for review and approval.

Following approval, applicants should submit drug import license applications electronically to the Thai FDA’s Medicines Regulation Division for review and approval via the Thai FDA’s One Stop Service & Consultation Center (OSSC) (THA-35) using the Skynet web portal.

Following approval by the Thai FDA, the import license is issued to allow the supply of the IMP.

4.6 Does the RA/CA provide written acknowledgment of the submitted application? If not, describe how the application is tracked.

Applications can be tracked electronically. The officers record the license request in the database and the results of the request in the information system to which it is linked using the License Per Invoice (LPI) system.

4.7 What is the relevant RA/CA fee in local currency/USD? Please provide as much information as possible (e.g. if the fee is different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, etc.) 

The only fee available relates to the issuance of the Import Licence which is 4000 Baht (= USD 120).

4.8 Does RA/CA accept checks or payment can be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?

Payment is to be made online through an e-submission link on the Skynet web portal.

4.9 Is there any guidance tool available for making electronic applications? If yes, provide the link and/or step-by-step instructions.

No specific guidance has been found in this regard. However, the electronic application is a stepwise process.

4.10 Does RA/CA require any screenshots/mock screens for participant-facing materials?

Where patient-facing materials are provided electronically, screenshots should be provided. These should be in the local language.