International regulatory news in brief

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This post covers international regulatory news in brief. It will be updated on an ad hoc basis. To ease navigation, tabs have now been added for each region. Latest updated section(s): EU (Finland), Oceania (Australia) Photo by Markus Winkler on Unsplash

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CMDh updates – September 2021

CMDh contact points The list of CMDh contact points has been updated and is available for download on this page. CMDh Draft agenda for the meeting of 14-16 September 2021 The draft agenda for the meeting is available here.

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EMA and FDA launch pilot program for parallel scientific advice (PSA) for hybrid products and complex generic products

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program to provide parallel scientific advice (PSA) to applicants of marketing authorisation applications (MAAs) for: hybrid products (EMA) and abbreviated new drug applications…

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The EU Digital Application Dataset Integration Project (DADI) project on web-based regulatory application forms

The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms is currently in progress. This project should have a wide ranging and positive impact on industry stakeholders and regulatory agencies in the EU. At its core appears…

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