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EU Pharma Reform Passes Major Hurdle, With Big Changes To Data Protection Proposals

 
• By Ian Schofield

Members of the European Parliament have significantly watered down plans for a cut to regulatory data protection, but industry says the net effect of the proposals will still be to make Europe “less competitive and less attractive” to investment in innovation.

Pills with euro union flag, medicine
The EU pharma reform has taken a big leap forward • Source: Shutterstock/Vladimir Sukhachev

Plans to overhaul the EU’s medicines legislation took a major step forward on 19 March when a European Parliament committee voted to approve the “pharmaceutical package” published by the European Commission in April 2023, albeit with some major changes to the proposals on regulatory data protection (RDP).

As part of a set of compromise amendments intended to reconcile opposing political positions on the proposals, the parliament’s environment...

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EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
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Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.

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US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
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Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

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EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.