Regulatory Blog

Philippines FDA: Authorization for Registration Applications of Pharmaceutical Products and Active Pharmaceutical Ingredients for Human Use

Philippines FDA: Guidance on Use of FDA eServices Portal for the Initial Application of CMDN

Philippines FDA: Publishing of Package Insert & PIL of Registered Drug Product in Verification Port

Philippines FDA: Guidelines on the Application for License to Operate

Philippine FDA: Guidelines for Importation and Exportation of Finished Drug Products & Raw Materials

Philippines FDA: Guidelines on Regulatory Reliance on the Conduct of Clinical Trials

Philippines FDA: Draft Guidance Frontline Services of the FDA in the New Normal

Philippines FDA: Guidance Reliance for Regulatory Decisions & Regulatory Response on National PHE

Philippines FDA: Guidelines on the Unified Licensing Requirements

Philippines FDA Guidance: License to Operate (LTO) Application of Retailers of Medical Devices

Philippines FDA - Guidelines on Abridged and Verification Review Pathways for New Drug Registration

Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price - Philippines FDA

Philippines FDA: Guidelines on the Licensing of Retailers of Medical Devices

Guidance on Issuing of an Authorization for Med Device based on ASEAN Requirements - PhilippinesFDA