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Philippines FDA Draft Guidelines: Navigating Post-Approval Changes, Device Variations, and Establishment Inspections in 2025
The Philippines FDA ("FDA Philippines") continues to enhance its regulatory frameworks to streamline processes and align with international best practices. Three recent draft guidelines open for public comments address critical areas impacting pharmaceutical products and medical devices for comment: Implementing Guidelines on the Post-Approval Changes of Registered Pharmaceutical Products for Human Use  (for human medicines) Guidelines on the Application for Variation of the
Sharan Murugan
Nov 12 min read
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Philippines FDA: Authorization for Registration Applications of Pharmaceutical Products and Active Pharmaceutical Ingredients for Human Use
The Philippines Food and Drug Administration (FDA) has released a draft (for comments) "Rules and regulations for the authorization and...
Sharan Murugan
May 18, 20241 min read
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Philippines FDA: Guidance on Use of FDA eServices Portal for the Initial Application of CMDN
On 4 Decemberber 2023, the Philippines FDA released draft guidelines on the "Use of the Food and Drug Administration eServices Portal...
Sharan Murugan
Dec 6, 20232 min read
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Philippines FDA: Publishing of Package Insert & PIL of Registered Drug Product in Verification Port
Recently (23 June, 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline for comments "Guidelines...
Sharan Murugan
Jun 27, 20231 min read
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Philippines FDA: Guidelines on the Application for License to Operate
Yesterday (6 June 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline "Guidelines on the...
Sharan Murugan
Jun 6, 20231 min read
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