EMA, PIC/S To Update 11-Year-Old GMP Guide On Computerized Systems
Executive Summary
The European Medicines Agency and the international association of pharmaceutical inspectorates, PIC/S, say they need to make extensive changes to their guide on using computerized systems when manufacturing medicines.
You may also be interested in...
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.
EMA Takes Steps To Improve Predictability Of Drug Submissions
The European Medicines Agency says it will become more systematic in seeking explanations from companies who delay or withdraw their planned marketing submissions and in chasing “no-shows.”