During a third phase of the pilot, set to begin in the third quarter of 2027, the EMA will open the program to IVD makers and notified bodies.

US, European regulators set principles for 'good AI practice' in drug development The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe and ...

This press release was updated on 11 October 2023 to include the text of the provisional agreement. The presidency of the Council and European Parliament negotiators reached a provisional agreement on ...

Regulators stress accountability: FDA and EU frameworks require sponsors to maintain oversight of CDMOs, treating outsourcing as an extension of the pharmaceutical quality system. Quality control as ...

Although medicine research and development (R&D) continues to rely heavily on data from animal models to evaluate safety, efficacy and quality of medicines 1, ethical concerns and the urgent need for ...