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EMA OPEN Framework 2026 Update: What Pharma and Regulatory Affairs Teams Need to Know
The EMA OPEN framework (Opening Procedures at EMA to Non-EU Authorities) allows the European Medicines Agency (EMA) to run near-concurrent scientific assessments of certain medicines alongside seven non-EU regulatory partners, while each authority keeps full independence over its own decision. Originally piloted for COVID-19 medicines in December 2020, it was expanded to a wider range of therapeutic areas on 20 July 2023 and remains the operational basis for cross-border coll
3 hours ago11 min read