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EMA Picks Antibiotic Combo & RSV Vaccine For New International Parallel Review Framework

 
• By Neena Brizmohun

The first products to be selected for review under the European Medicines Agency’s newly extended OPEN framework for collaboratively assessing marketing applications with non-EU authorities are from Pfizer/AbbVie and Moderna.

Brainstorming. Joint project. Development of innovations and technologies. Research. Cooperation
The EMA's OPEN framework enables international collaboration on marketing application reviews • Source: Shutterstock

Aztreonam-avibactam, Pfizer/AbbVie’s candidate for treating multidrug-resistant infections, and mRNA-1345, Moderna’s investigational respiratory syncytial virus (RSV) vaccine for older adults, are the first two products to be earmarked for review under the European Medicines Agency’s newly extended OPEN framework for collaboratively assessing marketing applications with non-EU authorities.

Key Takeaways
  • The European Medicines Agency's newly extended OPEN framework provides for near-concurrent review of drug marketing applications by one or multiple additional regulatory authorities, each conducting their own assessment in parallel to the EMA evaluation while sharing scientific expertise and maintaining their scientific and regulatory independence.

Switzerland’s drug regulator, Swissmedic, will be involved in the OPEN initiative as part of the review of mRNA-1345, Moderna told...

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