What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
PRAC Strategy on Measuring Pharmacovigilance Activities
In 2017, PRAC established a strategy for measuring the impact of pharmacovigilance activities, and EMA has published a second revision in April 2022. The second revision of the PRAC Impact Strategy integrates the achievements over a five-year period since its launch in [...]
The EUDAMED UDI/devices module updated technical documentation is available
The European Commission published a series of new UDI device related documents. UDI/Devices User Guide for Economic Operators EUDAMED UDI/Device data dictionary V2.7 UDI Device Business rules v2.7 UDI Device enumerations v2.7 MDR and IVDR introduce an EU device [...]
EUDAMED UDI/devices Updated Technical Documentation Module
The European Commission published a series of new UDI device related documents. UDI/Devices User Guide for Economic Operators EUDAMED UDI/Device data dictionary V2.7 UDI Device Business rules v2.7 UDI Device enumerations v2.7 MDR and IVDR introduce an EU device [...]
EMA’s advice on managing the impact of the war in Ukraine
EMA has published an advice to sponsors on managing the impact of the war in Ukraine on clinical trials. The ongoing war in Ukraine is affecting clinical trials. Sponsors have asked for guidance on how to handle the situation [...]
EMA publishes Updated Version of Good Clinical Practice (GCP) Q&A
The European Medicines Agency (EMA) has published an updated version of its good clinical practice questions and answers (#GCP Q&A). EMA provides guidance in forms of questions and answers on GCP, as discussed and agreed by the GCP Inspectors [...]
BVMed and SNITEM: Overcoming the MDR implementation bottleneck
The BVMed - German Medical Technology Association and SNITEM - the French National union of the medical technology industry are launching a Franco-German initiative for Medical Device Regulation. In a joint statement, they call for three important points and [...]
Spain: AEPD Approves 1st Industry Code of Conduct to Enable Compliance with the GDPR
The Spanish Data Protection Authority (AEPD) has recently approved the first industry code of conduct (CoC) under the General Data Protection Regulation (GDPR). The CoC has been promoted by Farmaindustria (the National Business Association of the Pharmaceutical Industry) and [...]
Swiss Single Registration Number – CHRN
The Swiss Single Registration Number (CHRN) is assigned by Swissmedic based on the Medical Device Ordinance (MedDO; SR 812.213). It is assigned to Swiss manufacturers, authorised representatives or importers and serves to uniquely identify them. Meditrial successfully represents many [...]
Swiss Medical Device Database is Under Construction
Swissmedic is in the process of developing a new database for registering economic operators and medical devices. Due to the continuing aim of equivalence between regulation in Switzerland and the EU, the medical devices database will be similar to EUDAMED. [...]
