European Regulatory Strategy ‘Should Prioritize Real World Evidence’
Innovative Clinical Trials Should Be Priority Too, Says EFPIA.
EFPIA, the European Federation of Pharmaceutical Industries and Associations, has put forward what it thinks the European regulatory network strategy to 2025 should prioritize.
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Regulators have produced yet another strategy outlining the challenges and next steps for the European drug regulatory network as the network prepares for a future characterized by rapid developments in science and technology, medicines access issues, supply chain weaknesses and emerging health threats.
In an exclusive interview with the Pink Sheet, the European Medicines Agency’s Tony Humphreys explains the thinking behind the agency’s regulatory science strategy, why the PRIME scheme is to get a boost – and why the need to tackle health threats ranked so low in a stakeholder consultation.
Draft guidelines due out for consultation this week in Italy are expected to shed more light on what companies will have to reveal during pricing and reimbursement negotiations.