EU Proposal Seeks To Address Borderline Product Classification ‘As Early As Possible’
The European Commission’s draft regulation for reforming the EU medicines legislation has proposed a new product classification mechanism for borderline cases where it is not clear if a product is a medicine or falls under another area such as medical devices.
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EU Pharma Reform Proposes Cuts In Regulatory Protections & Faster Drug Approval Times
Proposals for the overhaul of the EU pharmaceutical legislation will make medicines more widely available, accessible and affordable while supporting innovation and boosting the “competitiveness and attractiveness” of Europe’s pharma industry, the European Commission claims. The research-based industry thinks otherwise, saying cuts in regulatory protections will undermine R&D.
Advanced Therapy Developers Urged To Monitor Major EU Proposal On Using Blood, Tissues & Cells
Companies have the opportunity to tell the European Commission what they think about its proposed regulation that would overhaul the rules governing the use of substances of human origin.
EU CHMP Opinions And MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.