EMA AND AUSTRALIAN PHARMA REGULATOR COLLABORATE ON ORPHAN MEDICINES
April 12th, 2014
THE EUROPEAN Medicines Agency (EMA) and Australia’s Therapeutic Goods Administration (TGA) will henceforth share full assessment reports on marketing authorisation applications for orphan medicines intended to treat rare diseases. A cooperation agreement between the two regulators “will reinforce collaboration and work-sharing between the two regulatory authorities and will contribute to accelerating access to new medicines for patients with rare diseases in Europe and in Australia,” said an EMA note, which added: “Global collaboration on orphan medicines ...
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