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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
44 views
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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
92 views
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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
136 views
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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
224 views
0 comments
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...
Sharan Murugan
May 28, 20232 min read
434 views
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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...
Sharan Murugan
Mar 4, 20231 min read
138 views
0 comments
Philippines FDA: Draft Guidance Frontline Services of the FDA in the New Normal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;...
Sharan Murugan
Jan 8, 20231 min read
26 views
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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;...
Sharan Murugan
Nov 27, 20222 min read
61 views
0 comments
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...
Sharan Murugan
Oct 9, 20222 min read
224 views
0 comments
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...
Sharan Murugan
Sep 17, 20221 min read
55 views
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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...
Sharan Murugan
Jun 18, 20221 min read
109 views
0 comments
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...
Sharan Murugan
May 2, 20221 min read
37 views
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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...
Sharan Murugan
Oct 13, 20211 min read
134 views
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Guidance on Issuing of an Authorization for Med Device based on ASEAN Requirements - PhilippinesFDA
The Philippine Food and Drug Administration (FDA) released an addendum to circular (to FDA Circular No. 2021-002) on the transition to...
Sharan Murugan
Aug 19, 20211 min read
29 views
0 comments