EU’s Plans for Regulatory Data Protection ‘Unworkable’
The European Commission will have a fight on its hands when it comes to the data protection part of its proposals for EU pharma legislative reform.
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Dissent In Parliament As Commission Claims EU Pharma Revision Will Improve Competitiveness and Access
Proposals on regulatory data protection and transferable exclusivity vouchers to encourage antimicrobial R&D have received mixed reactions from the parliament’s rapporteurs for the draft legislation.
Faster regulatory reviews proposed in the European Commission’s pharmaceutical reform package could impact the EU-level joint clinical assessments that go live from 2025.
IQWiG, Germany’s health technology assessment (HTA) body, is calling for EU legislative reforms to do more to promote better evidence that addresses the questions health systems and HTAs have about the added benefits of new medicines.