Objectives of the Circular
- Establish procedures for filing and submission of applications related to clinical trials, compassionate special permits, import permits, and related documents.
- Promote simplified, transparent, and convenient processes for industry partners.
Scope of Application
- Covers establishments/institutions applying for:
- Clinical Trial Protocol approval
- Compassionate Special Permit (CSP)
- Import Permit for Investigational Drug Products
- Submission of Adverse Events/Adverse Reaction Reports
- Pharmacovigilance reports including PSUR, PBRER, Safety Updates, and Risk Management Plans, as defined under RA 9711 and FDA issuances.
Filing Procedures and Requirements
- Filing location: PAIR Unit, daily from 8:00 AM to 5:00 PM, with no prior appointment needed.
- Variation applications (e.g., additional indication, labeling changes) must be filed as VARIATION applications following ASEAN Variation Guidelines.
- Additional dosage strengths or forms require filing through established ACTD/ACTR or national guidelines.
- Documentary requirements:
- Must be scanned as PDF and stored on a USB device.
- Covering letter signed by regulatory affairs officer in duplicate submitted along with the USB.
- Payments:
- Must be made at the FDA Cashier before submission.
- Assessment Slip and Official Receipt must be presented upon submission.
- Submission procedure:
- PAIR staff will receive the documents, copy electronic files, and return the USB immediately.
- A Document Tracking Slip with a 14-digit Document Tracking Number (DTN) signed by PAIR staff will be issued for tracking.
Repealing Clause
- This circular supersedes any previous guidances or regulations that are inconsistent with its provisions.
Effectivity
- The circular took effect on April 7, 2014.