Question & AnswerQ&A (FDA CIRCULAR NO. 2014-009)
The main purpose of FDA Circular No. 2014-009 is to prescribe and establish the procedure for filing and submission of applications for Clinical Trial Protocol approval, Compassionate Special Permit, Import Permit for Investigational Drug Products, and other related documents to provide a simplified, transparent, and convenient process.
Republic Act 9485, known as the Anti-Red Tape Act of 2007.
All establishments, institutions, and organizations applying and seeking approval for Clinical Trial Protocol, Compassionate Special Permit, Import Permit for Investigational Drug Products, and other related documents, as well as those submitting Adverse Events/Adverse Reaction Reports, Periodic Safety Update Reports, and related regulatory submissions.
Applications must be filed and received at the FDA Public Assistance, Information and Receiving (PAIR) Unit daily from 8:00 am to 5:00 pm.
No, email requests for appointment schedules are not required before filing applications.
They should be filed as VARIATION applications with appropriate fees in accordance with the ASEAN Variation Guidelines and FDA Circular No. 2014-008.
All documentary requirements should be scanned as PDF files and stored in a USB device, accompanied by a printed covering letter signed by the regulatory affairs officer submitted in duplicate.
Payment of the appropriate fees must be made first at the FDA Cashier and an assessment slip with payment details must be submitted together with the application.
The Public Assistance, Information and Receiving (PAIR) Unit issues a Document Tracking Slip containing a fourteen-digit Document Tracking Number (DTN), which serves as a reference number for tracking the application.