Global Medtech Guidance Tracker: November 2022
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.
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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.
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.
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.