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The IND application Philippines process is a regulated pathway overseen by the Food and Drug Administration (FDA) to authorize the conduct of clinical trials using investigational products. This process under the FDA Philippines IND process ensures participant safety, scientific integrity, and compliance with national standards before any clinical trial begins.
Understanding the Clinical trial approval Philippines framework is critical for sponsors and CROs planning early-phase and late-phase studies in the country.
- Determine Eligibility and Prerequisites
- Who may apply? Sponsors, Contract Research Organizations (CROs), importers, and principal investigators involved in clinical trials.
- Precondition: The applicant (company or institution) must hold a valid License to Operate (LTO) issued by the FDA Philippines.
Prepare Required Application Documents
Key documents required under Philippines clinical trial regulations, based on Administrative Order No. 2020-0010 and the most recent FDA Citizen's Charter (2024):
- Cover Letter (FDACRS Form 2.0)
- Clinical Trial Application Form (see Appendix D1 in AO 2020-0010)
- Investigational Product and Ancillary Supplies Information
- Import License Application Form (for imported IND)
- Clinical Trial Protocol and amendments
- Good Clinical Practice (GCP) Certificate & Curriculum Vitae (CV) of investigators
- Informed Consent and Assent Forms for trial participants
- Investigator’s Brochure
- Pharmaceutical Data & GMP Certificate from NRA or proof of GMP compliance
- Shipping conditions, labeling, ethics committee approval, and related correspondence
- Proof of payment (Application Fee: Php 500 + Legal Research Fee, as referenced in AO No. 50 S. 2001)
- Submission Procedure
- Pre-assessment Email: Send all digital application materials to the FDA through clinicalresearch@fda.gov.ph (see procedure in Citizen’s Charter).
- Ensure to follow submission schedules as published on the FDA website.
- Application Review:
- The FDA pre-assesses completeness.
- If requirements are met, a Document Tracking Number (DTN) is issued, and payment instructions are sent.
- If incomplete, feedback and reasons for rejection are provided.
- Pre-assessment Email: Send all digital application materials to the FDA through clinicalresearch@fda.gov.ph (see procedure in Citizen’s Charter).
- Payment of Fees
- Pay the required fees once an Order of Payment is received.
- Attach proof of payment to the submission, referencing AO 50 s. 2001 for official rates https://www.fda.gov.ph/administrative-order-no-50-s-2001/
- Technical Evaluation and Regulatory Review
- After payment confirmation, the FDA’s Center for Drug Regulation and Research (CDRR) conducts a technical and Regulatory review of both administrative and scientific content.
- FDA may request further information, clarification, or additional materials via email.
- Review includes assessment of protocol, investigator credentials, GCP compliance, and product information.
- Approval and Issuance
- Result Notification: The FDA issues an official result (approval or denial).
- If approved: An Import License (for importation of IND), trial-specific authorizations, or other relevant permits are released.
- If denied: Reasons and instructions for resubmission or appeal are given.
- Post-Approval: Sponsor or CRO is responsible for:
- Conduct of the approved clinical trial
- Ongoing pharmacovigilance
- Timely reporting of adverse events and trial outcomes per FDA and Ethics Committee requirements.
- Result Notification: The FDA issues an official result (approval or denial).
Summary
Step | Description |
| 1. Eligibility Check | Ensure sponsor, CRO, or investigator has a valid FDA LTO; verify that the study qualifies as a clinical trial for an investigational product. |
| 2. Document Preparation | Prepare CTA Form, Cover Letter, Investigator’s Brochure, GCP certificates, protocol, GMP certificate, ethics approval, IC forms, and ancillary product information. |
| 3. Pre-Assessment Submission | Send all documents via email to clinicalresearch@fda.gov.ph following FDA's submission schedule. |
| 4. Payment | Once the Document Tracking Number (DTN) and Order of Payment are issued, pay the required fee under AO 50 s. 2001. |
| 5. Technical Review | CDRR conducts scientific and administrative review, may request clarifications, and verifies investigator qualifications and GCP compliance. |
| 6. FDA Decision | Approval results in an Import License or Clinical Trial Authorization; denial includes reasons and resubmission guidance. |
| 7. Post-Approval Duties | Sponsors/CROs must conduct safety monitoring, report AEs/SAEs, and comply with FDA and Ethics Committee requirements. |
Conclusion
The IND application Philippines follows a structured Regulatory pathway designed to ensure investigational products meet ethical, scientific, and safety standards before entering clinical trials. By following FDA guidelines, maintaining complete documentation, and ensuring continuous compliance, sponsors and CROs can navigate the IND system efficiently.
With extensive experience in global Regulatory strategy and clinical trial support, Freyr can help organizations streamline their IND submissions in the Philippines—ensuring accuracy, faster approvals, and full compliance with FDA requirements.
