EMA Wants Authority To Request Modifications To Agreed PIPs
This article was originally published in SRA
Executive Summary
As the time draws near for the 10-year review of the EU Paediatric Regulation, the European Medicines Agency has indicated certain changes that it would like the legislation to support in the future.
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.