Sweden to merge drug and device authorities?:
This article was originally published in Clinica
Executive Summary
The Swedish authorities are considering whether medical device and pharmaceutical regulation should be dealt with by a single agency. The National Board of Health and Welfare, which includes a medical devices unit, has been holding preliminary discussions with the Medicines Products Agency to decide whether a merger would be appropriate. The Medicines Products Agency is responsible for pharmaceutical and cosmetics regulations. Several other European countries have been considering the advantages of bringing the two regulatory sectors together - France has recently set up its Agency for Healthcare Product Safety, which covers both drugs and devices, while in the UK the Medicines Control Agency and the Medical Devices Agency have decided to reject merger proposals for the time being.