The Department of Health of the Philippines has recently issued Circular No: 2020-002 on 06 February 2020 pursuant to the Food, Drugs and Cosmetics Act.
The circular is intended to provide a clearer picture of the registration of new influenza vaccines. In the effort to streamline the registration process in the Center for Drug Regulation and Research, the circular aims to provide regulatory guidance and requirement for variation in the application for influenza strains.
The Circular shall be applicable to all manufacturers and distributors( e.g importers and wholesalers) of influenza vaccines for human.
In addition, the Circular clearly spells out the registration and submission process to obtain the Monitored Release (MR) status, Major Variation-Strain Clearance ( MaV-SC), and Minor Variation Strain Clearance(MiV-SC). This streamlining of processes assists in ensuring that vaccines maintain their quality, safety, and efficacy.
The manufacturers and distributors of the influenza vaccines are also informed on the validity period for the registration and the fees prescribed for monitored release and variation. The payment for additional consequential changes shall be on per product and per change basis and shall abide by the existing requirements under FDA Circular No. 2014-008 “ Application Process and Requirements for Post Approval Changes of Pharmaceutical Products”.
Further information on the circular can be referred to https://ww2.fda.gov.ph/attachments/article/647800/FDA%20Circular%20No.2020-002.pdf