EC programme to ease future member state cooperation with EMA

Published: 16-Apr-2010
Regulatory

Programme aims to help countries wishing to join adopt EU pharmaceutical regulations


The European Commission (EC) has launched a programme to help countries wishing to join the European Union (EU) adopt EU pharmaceutical regulations and work with the European Medicines Agency (EMA).

The EC’s Instrument for Pre-accession Assistance (IPA) Programme will help the governments of Croatia, Macedonia and Turkey, who are negotiating EU entry, and those awaiting formal membership talks, including Albania, Bosnia & Herzegovina, Montenegro, Serbia and Kosovo.

According to the EMA: ‘The project [was] designed to establish with the beneficiary countries an internationally open dialogue and working mechanisms that [will] … facilitate the adoption of common technical requirements.’

EC officials will examine the existing pharmaceutical control regimes within these countries to see what reforms are needed to bring them in line with the EU legislation they must adopt to become a member of the EU. They will also prepare national bureaucrats on how to participate in EMA committees and on interacting with relevant EU electronic information networks.

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