Europe to boost cooperation with international partners on generics
European system to be used as model to facilitate assessment of medicines
The European Union’s decentralised procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of theInternational Generic Drug Regulators Pilot (IGDRP).
The European Union (EU) is leading an international pilot project through which, upon request from a generic pharmaceutical company, it will share the assessment reports generated as part of the decentralised procedure in real time with collaborating regulatory agencies outside the EU.
By offering to share its assessment reports, the EU aims to reinforce collaboration and information-sharing between regulatory authorities across the world, contributing to facilitating and strengthening the scientific assessment process for medicines. This should enable medicines to be authorised in different territories in a coordinated way at approximately the same time.
The first phase of the…
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