Swissmedic and EMA take steps to improve information-sharing

The Swiss Agency for Therapeutic Products (Swissmedic) and the European Medicines Agency (EMA) have improved their information-sharing, with Swissmedic starting to enter information on good manufacturing practice (GMP) to the EU’s EudraGMDP database.

The EMA has reported that this should lead to easier information-sharing and therefore lead to efficiency gains for stakeholders.

This development is part of the ‘mutual recognition agreement’ (MRA) between the EU and Switzerland. The EMA reports that:

“The latest amendment introduced the provisions on data entry to EudraGMDP by the Swiss authorities. Swissmedic has ‘read and write’ access to the data base and will be entering GMP compliance information on Swiss manufacturers, including those exporting to the EU. As a consequence, the regulatory requirement to provide original paper GMP certificates issued by EU or Swiss authorities will be replaced by either the provision of a reference to an entry in EudraGMDP or by means of a downloadable file or printout from the data base.”

The EudraGMDP database is the EU’s database on manufacturing, import and wholesale-distribution authorisations, and GMP. ‘Read and write’ access to EudraGMDP is granted to all regulatory authorities of countries with which the EU and an MRA.

Read the EMA’s article on this news here. For further information about Europe and market access visit MAP Europe.

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Published on 22. February 2019 in News, News EU