EU Opens Long Awaited Consultation On Joint Clinical Assessments

Stakeholders have until 2 April to comment on the European Commission’s draft implementing act for joint clinical assessments. Industry federation EFPIA says the proposal contains numerous challenges for pharmaceutical sponsors.

waiting room
EFPIA said it has been a long wait for the EU consultation on JCAs • Source: Shutterstock

The European Commission’s proposed methodologies for performing EU-wide joint clinical assessments (JCAs) for medicinal products, a key part of the wider health technology assessment Regulation, are open to public scrutiny until 2 April.

The 18-page draft JCA implementing act document sets out a proposed framework for rolling out JCAs under the new HTA Regulation, including the roles of different entities involved, such as the JCA subgroup, the HTA Coordination Group and the commission itself

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