PSUR Repository

The PSUR repository is a single, central platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the EU. The PSUR Repository provides an important simplification for marketing authorisation holders allowing them to send all PSURs and related submissions to a single recipient. It also facilitates the assessment…

EU Council and Parliamentary Committees Sign Off on New Medical Device, IVD Regulations

The European Council’s Permanent Representatives Committee and the European Parliament’s Environment and Health Committee on Wednesday endorsed the agreement reached on the continent’s new medical device and in vitro diagnostic (IVD) regulations, a day after the draft versions of the texts were released. Following a legal-linguistic review of the two documents planned for September, the Council…

Foreign companies show interest in Belarusian pharmaceutical projects

Foreign companies show interest in projects to develop Belarus’ pharmaceutical industry, Head of the Belarus President Administration Alexander Kosinets said during his working visit to Vitebsk Oblast on 19 March, BelTA has learned. The official paid a visit to the veterinary drugs company BelVitunifarm to discuss the progress in the implementation of an investment project…