The Spanish Agency for Medicines and Health Products (AEMPS) has expanded its accelerated evaluation process (fast-track), including bioequivalence studies. Interested sponsors must contact AEMPS before submitting the application to benefit from this process. This email should include the…
The Spanish Agency for Medicines and Health Products (AEMPS) has introduced an accelerated evaluation process (fast-track) to enhance Spain’s appeal for research on innovative medicines. This process will reduce the timelines for studies meeting the following criteria: Interested…
The Clinical Trials Information System (CTIS) is the online system for the regulatory submission, authorization, and supervision of clinical trials in the European Union and the European Economic Area. CTIS is the single entry point for clinical trials in…
According to Farmaindustria, Spain is the European country with the highest participation in clinical trials. Of the 1,944 clinical trials authorized in the European Union through the new European Information System (CTIS), Spanish sites participated in 845 (43%).…
FINAL APPROVAL EU PORTAL AND DATABASE BY EMA’s MANAGEMENT BOARD Great news upcoming! Yesterday, EMA’s Management Board confirmed that the clinical trial EU Portal and Database, is now fully functional and on track to go live by 31…
