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Sharan Murugan
May 18, 20241 min read
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...
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Sharan Murugan
Dec 6, 20232 min read
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...
80 views0 comments
Sharan Murugan
Jun 27, 20231 min read
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...
128 views0 comments
Sharan Murugan
Jun 6, 20231 min read
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...
208 views0 comments
Sharan Murugan
May 28, 20232 min read
Philippine FDA: Guidelines for Importation and Exportation of Finished Drug Products & Raw Materials
Last Friday (26 May 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline "Guidelines for the...
353 views0 comments
Sharan Murugan
Mar 4, 20231 min read
Philippines FDA: Guidelines on Regulatory Reliance on the Conduct of Clinical Trials
Yesterday (3rd March 2023) the Philippines Food and Drug Administration (FDA) released an updated guideline "Guidelines on Regulatory...
131 views0 comments
Sharan Murugan
Jan 8, 20231 min read
Philippines FDA: Draft Guidance Frontline Services of the FDA in the New Normal
Recently on 4th January, 2023 the Philippines Food and Drug Administration (FDA) released a draft guideline for comments i.e;...
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Sharan Murugan
Nov 27, 20222 min read
Philippines FDA: Guidance Reliance for Regulatory Decisions & Regulatory Response on National PHE
Recently on 25th November, 2022 Philippines Food and Drug Administration (FDA) released two draft guidelines for comments i.e;...
60 views0 comments
Sharan Murugan
Oct 9, 20222 min read
Philippines FDA: Guidelines on the Unified Licensing Requirements
Philippines FDA (on 04-October-2022) released the draft “Revised Guidelines on the Unified Licensing Requirements and Procedures of the...
195 views0 comments
Sharan Murugan
Sep 17, 20221 min read
Philippines FDA Guidance: License to Operate (LTO) Application of Retailers of Medical Devices
On 13 September 2022, the Philippines FDA released updated guidelines on the Use of the Food and Drug Administration eServices Portal...
51 views0 comments
Sharan Murugan
Jun 18, 20221 min read
Philippines FDA - Guidelines on Abridged and Verification Review Pathways for New Drug Registration
Abridged review refers to a limited independent assessment of specific parts of the dossier, or submission for suitability of use under...
99 views0 comments
Sharan Murugan
May 2, 20221 min read
Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price - Philippines FDA
The Philippines' Food and Drug Administration (FDA) is seeking feedback on draft guideline aimed at streamlining the process of changing...
37 views0 comments
Sharan Murugan
Oct 12, 20211 min read
Philippines FDA: Guidelines on the Licensing of Retailers of Medical Devices
On 8 May 2020, the Philippines Department of Health (DOH) entitled “Revised Guidelines on the Unified Licensing Requirements and...
132 views0 comments