Blogs

Focus On Regulation

Algorithms in the spotlight of antitrust authorities

Joint study by the Bundeskartellamt (German Cartel Office) and the Autorité de la concurrence (French Competition Authority) indicates need for higher compliance standards.

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European Commission provides clarification regarding the implementation of the Clinical Trials Regulation

The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding...

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European Medicines Agency’s new guide on the wording of therapeutic indication

On 21 October 2019, the European Medicines Agency (EMA) published a guide for assessors of centralised applications for marketing authorisation. The guide focuses on the wording used in...

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Heads of Medicines Agencies publishes practical guidance on nitrosamines

In late October 2019, the Co-ordination Group for Mutual Recognition and Decentralised procedures – Human (CMDh) of the Heads of Medicines Agencies (HMA) published a practical...

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Germany’s proposed digital antitrust law: an ambitious project to regulate digital markets

Germany is about to implement an ambitious new "digital antitrust law" (GWB-Digitalisierungsgesetz) to effectively regulate online markets. The draft Ministerial bill on the 10th amendment...

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