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UK MHRA: Navigating UK Medicines Regulation: Licensing, Assessment and Variations
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has modernised its processes for evaluating, approving, and maintaining marketing authorisations (MAs) under a post-Brexit regulatory framework aligned with the Windsor Framework (effective January 2025). The MHRA’s guidance documents provide a clear roadmap for each of these phases: Variations to marketing authorisations (MAs)  – covers changes after a licence is granted. National Assessment Procedure for me

Sharan Murugan
1 day ago3 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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