The Philippines Food and Drug Administration (FDA) has issued Circular No. 2021-020 to provide updated post-marketing surveillance (PMS) requirements for new drugs under monitored release, streamlined with Administrative Order (AO) No. 67 s. 1989 “Revised Rules and Regulation on Registration of Pharmaceutical Products”, AO No. 2006-0021 “Supplemental Guidelines to AO 67”, and FDA Circular (FC) No. 2020-003 “Guidelines for Pharmaceutical Industry on Pharmacovigilance”, on the 21st of September 2021.
The circular discusses about the required compliance of FC 2020-003, where all biological and new drug product applications are required to have an accompanying RMP with all the essential content. The RMP shall contain a Pharmacovigilance (PV) Plan where the safety concerns on the product are discussed.
Regarding clinical studies, Phase IV clinical studies that were conducted or proposed to be conducted in other countries shall not be required to be duplicated as these foreign studies are recognized by the FDA.
The validity of a complete and accurate submission, after thorough assessment by the FDA, will be 5 years for these Monitored Release applications, and the initial registration process can be kickstarted after this. For pending applications, a post-approval letter shall be issued by FDA if local Phase IV clinical studies will still be conducted, or if additional local PV activities are required.
It is also important to note that FC No. 2018-012 has been rescinded.
More details can be found in “FDA Circular No. 2021-020 Revised Post-Marketing Surveillance Requirements for New Drugs under Monitored Release”, 21 September 2021: https://www.fda.gov.ph/fda-circular-no-2021-020-revised-post-marketing-surveillance-requirements-for-new-drugs-under-monitored-release/