Search
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
Aug 511 min read
New PRIME Tools to Accelerate Development of Medicines in the EU: What It Means for Industry and Regulatory Careers
In March 2026, the European Medicines Agency (EMA) made a landmark announcement. After completing a two-year pilot programme, the agency formally launched three major new features under its PRIME (PRIority MEdicines) scheme — powerful tools designed to improve how innovative medicines reach patients across the European Union. For pharmaceutical developers, biotech companies, and the regulatory professionals who support them, this is not a routine administrative update. It rep
Jul 213 min read