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USFDA Guidance: Alternative Tools for Facility Assessments in Pending Applications
The U.S. Food and Drug Administration (FDA) has issued a final guidance on 11th September 2025 titled “ Alternative Tools: Assessing Drug...

Sharan Murugan
Sep 142 min read
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EMA Guidance: Application of the Amended Variations Regulation from 1 January 2025
The European Medicines Agency (EMA) has updated its page on the " Application of the Amended Variations Regulation from 1 January 2025 "...

Sharan Murugan
Nov 1, 20242 min read
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Swiss Medic: Guidance on GMP compliance by Foreign Manufacturers & Application Establishment Licence for Medicinal Products
This Monday (24 April 2024) Swissmedic, updated its guidance on "GMP compliance by Foreign Manufacturers" and "Application establishment...

Sharan Murugan
Apr 22, 20242 min read
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Malaysian Guideline for Application of Clinical Trial Import Licence (CTIL) & Clinical Trial Exemption (CTX)
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) released an updated guideline on "Guideline for Application of Clinical Trial...

Sharan Murugan
Mar 29, 20242 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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