EMA ups generics cooperation

August 13, 2014

THE European Medicines Agency (EMA) has said the EU’s decentralised system is being used as a model to accelerate assessment of generic medicines applications in the International Generic Drug Regulators Pilot (IGDRP). Australia is involved in the first phase of this pilot project. The decentralised procedure meant assessment reports would be shared in real time with collaborating regulatory bodies upon request from a generic company, the EMA said. Sharing assessments would reinforce collaboration between regulatory authorities globally and should enable medicines to be authorised in different areas in a coordinated way at about the same time, the EMA said. New Zealand was a member of the IGDRP and might decide to take part at a later stage, the EMA said. To read more, CLICK HERE.

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Pharmacy Daily | EMA ups generics cooperation

EMA ups generics cooperation

Other recent headlines

PD breaking news – Pharmacists to administer NIP vaccinations in aged care

PD breaking news – Top Western Australian talent honoured

Legal action for Montu

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES