Radical Shake-Up In Store For Entire EU Pharma Legislation
Commission Proposals Tackle Regulation, Pricing, Shortages, Innovation – And Much More
The EU pharmaceutical strategy published on 25 November will be the first step in a “complete overhaul” of the medicines legislative framework to be proposed in about two years’ time, says the European Commission.
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Days before the EU Clinical Trial Regulation is set to come into effect, a new initiative has been launched to track and support its successful implementation and help deliver other trial-related reforms.
Further analysis is under way, but first impressions by EU R&D industry group EFPIA of policy proposals for tackling drug shortages are not good.
A European Commission study into the root causes of medicines shortages has identified a range of potential solutions, with the Commission identifying older, off-patent and generic drugs as the most at-risk.