Central repository for safety reports – one year to go before mandatory use

The European Medicines Agency (EMA) Management Board gave the go-ahead on 12th June 2015 for the central repository for periodic safety update reports (PSURs) for medicines authorised in the European Union (EU).

In one year’s time, on 13th June 2016, the central repository will become the single, central platform for these reports to be used by all regulatory authorities and pharmaceutical companies in the EU to exchange information on the safety of medicines.

The centralised PSUR repository provides an important simplification for the industry allowing marketing authorisation holders to upload the PSURs to one location. It also facilitates the assessment process by ensuring that NCAs in each member state, EMA and its scientific committees, and the European Commission have timely and secure access to all relevant documents.