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.

The information to be provided to the RA and EC is the same, as listed below:

1. Clinical trial protocol
2. Research brochure
3. Informed consent
4. Application form
5. Information on the test item
6. CoA
7. GMP Certificate
8. Summary batch protocol for three consecutive batches
9. Special lot release (for vaccines only)
10. GCP certificate of the researcher
11. Contract with the ORK
12. Insurance
13. Laboratory certificate
14. CV of the "Main Researcher"

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

The standard timeline for approval is 4-8 weeks. However, it can be extended if queries are raised by BPOM and there are no standard timelines for the Agency to close out these queries.

4.3 Does the regulation support electronic submission?

No. Submissions are still paper-based.

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

No. The applicant can be a CRO, but they must be based in Indonesia.

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

Whilst applications to BPOM can occur at the same time as the EC submission, BPOM will not commence review of the application until the EC approval has been granted.

1. BPOM will then convene a national scientific committee to review the application.
2. If there are queries from the committee, these will be sent to the sponsor.
3. If there are no queries, BPOM will approve or reject the application within 20 days.
4. If the trial is approved, an approval letter will be issued by the Ministry of Health. This approval letter is valid for 2 years. If the trial extends beyond 2 years, then an extension from BPOM must be sought.

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

The submission is made in person at the BPOM counter.

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 submission fees are published by the Ministry of Health but all of the available information is in Bahasa Indonesia.

https://www.kemkes.go.id/index.php

4.8 Does RA/CA accept checks or can payment 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?

Payments can be made using the electronic gateway. Specific information is not available without logging into the system.

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

Submissions must be made in hard copy. A checklist is available for sponsors to check that all of the required information is presented. 

There is guidance available on the BPOM website. However, this information is presented in Bahasa Indonesia. 

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

Yes. Where electronic materials are used, screenshots should be provided.