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E.U. Proposes New Policy for Reviewing Medicines

December 30, 2021

The European Commission proposed various steps to accelerate the approval of drugs and devices by E.U. member states. The proposed regulation on health-technology assessments would allow member states to identify emerging technologies; use common tools, methods, and procedures for joint clinical assessments and scientific consultations; and continue voluntary cooperation in other areas.

"The health-care sector is a crucial part of our economy [and] accounts for approximately 10 percent of the E.U.'s gross domestic product," said Jyrki Katainen, European Commission Vice President for Jobs, Growth, Investment and Competitiveness, in a statement. The regulation "will bring benefits to patients all over Europe, while encouraging innovation."

The proposal comes as drug makers are seeking ways to more readily gain needed regulatory approvals. In a statement, Nathalie Moll, head of the European Federation of Pharmaceutical Industries and Associations, called the proposal a "positive, collective step forward." Joint clinical assessments, for instance, "will facilitate faster access, avoid duplication at a national level, and deliver greater consistency, clarity, and predictability for everyone involved in the process."

Source: STAT News, January 31, 2018.

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