FDA Philippines Publishes General Rules and Regulations on the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Intended for Human Use
Administrative Order 2024-0013 establishes updated rules for the registration of pharmaceutical products and Active Pharmaceutical Ingredients (APIs) for human use, …
FDA PH Issues Guidelines on the Publishing of Package Insert and Patient Information Leaflet of Registered Drug Products in the Food and Drug Administration (FDA) Verification Portal System
Guidelines: A. Approved PI and PIL of all registered drug products shall be published by the FDA in the Verification …
Philippines FDA Publishes Circular on The Abridged Processing of Medical Devices Registration With Approval by The NRA of Any ASEAN Member Country
Philippines FDA issues Circular No. 2022-008 on 27th September 2022, aims to provide guidelines on the abridged processing of applications …
Philippines FDA Publishes Circular on Labelling Requirements of Drug Products under Maximum Retail Price
The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2022-005, which provides some information on the process …
Philippines FDA Publishes Circular on Abridged and Verification Review Pathways
The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2022-004, which provides insight on the facilitated registration …
Philippines FDA Updates Circular on Transition Period for Certificate of Medical Device Notification
The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2021-002-B, an amended version of Circular No. 2021-002-A. …
Philippines FDA Publishes Update on Transfer or Refund of Payments
The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2021-027, which is the revised guidelines for the …
Philippines FDA Publishes Advisory on Abridged Route for ASEAN-Registered Medical Devices
The Philippines Food and Drug Administration (FDA) has issued Advisory No. 2021-3084, with details regarding the abridged route for the registration of medical devices …
Philippines FDA Issues Circular on Revised Post-Marketing Surveillance Requirements for New Drugs under Monitored Release
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, …
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