No Amendments Any Time Soon For EU Paediatric Regulation, Says Hotly Awaited Report
The European Commission’s big report on the Paediatric Regulation which industry has been waiting for is finally out.
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Spring 2020 should see the publication of a working document by the European Commission on how to improve the operation of the EU legislation on orphan and pediatric medicines. The commission has asked for more input from member state experts.
A new European Commission consultation marks the launch of an evaluation exercise to assess the joint impact of the EU pediatric and orphan drugs legislation in supporting the development of pediatric medicines for rare diseases.
The European Commission's plans to evaluate the EU pediatric and orphan drugs regulation in tandem has prompted questions from the pharmaceutical industry on how exactly this critical exercise would proceed and what its ultimate objective would be.