EU’s Proposed Emergency Approval Route For Crisis-Related Products – Would It Work?
Executive Summary
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.
You may also be interested in...
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.
UK Industry ‘Struggling’ With Skill Gaps In AI, Robotics & Data Analytics
A new report says that pharma firms are finding it difficult to recruit staff with experience in emerging scientific technologies, particularly in areas such as regulatory and quality assurance. COVID-19, Brexit and competition for talent with other countries and industry sectors are cited as key factors.