EU’s Proposed Emergency Approval Route For Crisis-Related Products – Would It Work?
The temporary emergency marketing authorization, or TEMA, would be similar to the existing conditional approval while lasting only for the duration of the health crisis. But one law firm queries whether the new mechanism would be any faster in practice.
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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.
International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccine
A workshop led by the European Medicines Agency and the US Food and Drug Administration sought to reach alignment on adapting COVID-19 vaccines to emerging virus variants.
EU Adopts New Rules On UK-Wide Approvals For Novel Drugs
Having been passed by the European Parliament and now the Council of the EU, new legislation will clear up some of the issues raised by Brexit relating to trade in medicines between Great Britain and Northern Ireland.