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EU Pilots Streamlined Approach To Multinational Combination Product Trials

 
• By Vibha Sharma

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
Key Takeaways
  • A new EU strategy to streamline the conduct of combined studies involving medicinal products, IVDs and medical devices has been endorsed by member states.
  • The strategy concerns the EU’s COMBINE initiative, a two-part effort to address challenges with studies at the interface of the Clinical Trials Regulation, the IVD Regulation and the Medical Devices Regulation.
  • While the COMBINE’s first phase analyzed the issues involved and proposed possible solutions, the strategy is for the second phase organized as a program consisting of seven cross-projects.
  • Projects include testing a single assessment process for multi-national combined studies, and harmonizing adverse event reporting processes.

EU member states have endorsed

Also on the cards are projects to harmonize the processes for reporting adverse events in combined studies, and to explore new opportunities for advising sponsors and

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