Regulatory Blog

The European regulatory framework continues to strengthen data protection and transparency  in its international collaborations, particularly when engaging with EU candidate countries. As part of this effort, the European Medicines Agency (EMA) has established clear guidelines on how personal data is processed within cooperation programmes. The guidance European Medicines Agency’s Data Protection Notice for the implementation of the Instrument for Pre-accession Assistance (I

The guidance Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle  was issued on 30 March 2026 , updating and superseding the earlier 2016 guidance, and providing comprehensive recommendations on how patient preferences can inform benefit-risk assessments. The FDA recognizes that patients living with diseases or conditions develop first-hand insights into treatment benefits and risks. Their perspectives can play a critical role in evaluatin

The guidance Guide to manufacturers and notified bodies on the procedure for requesting advice from expert panels for orphan medical devices  was published on 31 March 2026 , outlining the procedural framework and expectations for applicants seeking scientific and regulatory advice. Orphan medical devices are those intended for the diagnosis, prevention, or treatment of rare conditions, where limited patient populations create challenges in generating extensive clinical evi