Global Medtech Guidance Tracker: November 2022
Executive Summary
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-eight documents have been posted on the tracker since its last update.
You may also be interested in...
First EU Guidance On Authorized Representative Role And Responsibilities
Manufacturers who are not based in the EU need to have an authorized representative. There is a high level of responsibility, and indeed liability, associated with the function. New guidance explains the rules around the role.
EMA Says Yes To BMS’ Sotyktu But Turns Down Ipsen’s Sohonos
The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OK’d new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.
Sponsors Split Over Benefits Of EU Clinical Trials Regulation
A survey undertaken last year on the implementation of the EU Clinical Trials Regulation drew some positive feedback from study sponsors but also threw light on well-known concerns with the legislation. Some of the highlighted issues are being addressed on a priority basis.