EU Drug Approvals Could Be Denied If Environmental Risks Not Properly Assessed
As part of its revision of the EU medicines legislation, the European Commission is proposing tighter rules to reduce the environmental impact of medicines. Companies may want to start thinking now about whether their current environmental risk assessment processes would meet the likely new requirements.
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Agreement On EU’s Radical Pharma Reform Plans ‘Could Take Three Years’
The controversial nature of some of the plans in the EU medicines legislative overhaul suggests a long road ahead for negotiations at the European Parliament and Council, with some “substantial amendments” likely along the way.
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.