Question & AnswerQ&A (FDA CIRCULAR NO. 2014-008)
The main purpose of FDA Circular No. 2014-008 is to promulgate the revised application process and requirements for instituting Post-Approval Changes (PACs) to registered pharmaceutical products, incorporating the ASEAN Variation Guideline (AVG) and country-specific requirements.
Any Marketing Authorization Holder (MAH) of a pharmaceutical product with a valid License to Operate (LTO) and with the product covered by a valid Certificate of Product Registration (CPR) may apply for PACs. If the CPR has expired, the pharmaceutical product must be applied for regular renewal registration.
The Circular applies to all manufacturers, traders, and distributors of pharmaceutical products covered by ACTD/ACTR. It also covers single and multi-component vitamin and mineral products, vaccines and biologics, traditional medicines, over-the-counter preparations, household remedies, medical gases, and veterinary products in the absence of a more specific regulation.
Post-approval changes are classified as Major Variation (MaV) and Minor Variation (MiV), where Minor Variation is further subdivided into Prior Approval (MiV-PA) and Notification (MiV-N) according to the ASEAN Variation Guideline (AVG). Country-specific requirements also specify certain MaV and MiV changes.
For changes requiring prior approval (MaV and MiV-PA), a Letter of Request for Post-Approval Change must be included in the application, indicating the specific type of PAC and all affected products.
Applications for PAC may be submitted any time during the validity of the CPR. If submitted at the end of CPR validity, it should be incorporated into the application for regular renewal registration.
Fees vary depending on the type of PAC. Regular PACs including change of capsule color cost P500 plus Legal Research Fund (LRF). Changes requiring clinical review or additional indication have higher fees up to P10,000 to P20,000 plus LRF. Fee payments are calculated per product, per change basis as detailed in Annex D of the Circular.
Pending PAC applications and their compliances at the time of effectivity of this Circular are not covered by the revised requirements and application process; only incoming PAC applications after effectivity are subject.
The FDA shall issue a Certificate or Clearance indicating each approved Post-Approval Change upon approval of the application.
If any provision in this Circular or its application is held invalid, the remainder of the provisions shall not be affected, thus implementing a separability clause.