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. 

Details of the requirements for submission of a clinical trial application are summarized below.

https://www.fda.gov.ph/clinical-trial-application-process/

Documents submitted should include those in Parts A, B, and C, and such other documents or data as hereinafter be required by the FDA to ascertain the safety, efficacy, and quality of the products that will be subject to clinical study.

PART A

Clinical Trial Protocol and Other Pertinent Documents:

1. Name and dosage form of product
2. Title and aim of the trial
3. Description of the trial design and subjects
4. Treatment profile and operational aspects
5. Adverse events and evaluation of results
6. An informed consent form, case report form, and patient information sheet
7. Resumes of principal and other investigators
8. For multi-center studies, a list of principal investigators (and CVs) including trial sites

PART B

Pharmaceutical Data:

1. GMP statement from manufacturing and certificate from a regulatory body
2. Certificate of Analysis and stability data
3. Manufacturing data, formulation, and product labeling

PART C

Investigator’s Brochure IB (Safety and Efficacy Data):

Safety Data

1. Non-Clinical Studies
2. Clinical PK/PD and toxicology Studies, risks, and ADR anticipated
3. Marketing experience, Periodic Safety Update Reports (PSUR), product status if marketed abroad

Efficacy Data

1. PK/PD data in Human Subjects
2. In-house preliminary data
3. Summaries of clinical trial studies conducted (Phase I, II, III)
4. Published clinical data

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 of a clinical trial application by the ethics committee is 60 days. Taking into consideration the coordination between the ethics committee and the FDA, the overall process can take around 3 – 5 months.

Another 30 days should be allowed for the issuance of an import permit for the IMP. 

4.3 Does the regulation support electronic submission?

Yes. All clinical trial applications must be submitted electronically.

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

The application may be submitted by the principal investigator or another authorized representative/CRO.

https://www.fda.gov.ph/draft-for-comments-guidelines-on-regulatory-reliance-on-the-conduct-of-clinical-trials-in-the-philippines-2/

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

1) CDRR evaluates the documents and determines if the study:

• Has scientific value and is worth pursuing/conducting.
• Is conducted by duly licensed establishments.
• Is compliant with GCP and other applicable best practices.
• Is compliant with the safety and efficacy standards of ICH.

2) The FDA passes these applications along to the Institutional Review Board/Ethical Review Board (IRB/ERB) for the conduct of ethical and technical review.

3) The IRB/ERB submits its recommendations for the approval or denial of the proposal to the FDA.

4) The FDA makes the final decision to approve or reject proposals.

5) If approved, the Import License (IL) and the Clinical Trial Approval (CTA) shall both be issued. The IL shall have a validity of three (3) years and can be used repeatedly within the validity period.

https://www.fda.gov.ph/draft-for-comments-guidelines-on-regulatory-reliance-on-the-conduct-of-clinical-trials-in-the-philippines/

https://credevo.com/articles/2018/04/30/philippines-clinical-trial-regulatory-process/

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

No, the status of an application can be checked through the online electronic portal. 

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 current FDA fees are listed on this link.

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?

Payment is made electronically through the application portal.

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

There is no specific guidance tool for making an electronic application. 

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

Yes. Where patient-facing materials are electronic, screenshots should be provided.