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Radical Shake-Up In Store For Entire EU Pharma Legislation

Commission Proposals Tackle Regulation, Pricing, Shortages, Innovation – And Much More

 
• By Ian Schofield

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.

Resilience
The EU pharma strategy is intended to make the sector more resilient in future • Source: Shutterstock

The new EU pharmaceutical strategy presented today encompasses a whole raft of proposed legislative and regulatory changes, such as the streamlining of drug approval procedures, better access to affordable medicines, and strengthened EU-level cooperation on pricing and reimbursement.

On the cards are measures to boost competition from cheaper generic and biosimilar drugs, align clinical trials to patient needs, and strengthen supply chains to avoid drug shortages

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Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
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Few Takers For EMA’s OPEN Pathway Prompts Rethink

 
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EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
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