EU Pilots Streamlined Approach To Multinational Combination Product Trials

EU regulators have approved a strategy to streamline the submission and approval of studies that involve the simultaneous investigation of a medicinal product, an IVD, and/or a medical device. The strategy involves rolling out seven cross-sector projects over the next few years.

Plane taking off
The FDA/EMA CoGenT Pilot program for gene therapies is taking flight. • Source: Shutterstock

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