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Focus On Regulation

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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What the European Medicines Agency’s qualification opinion means for electronic clinical data capture

The European Medicines Agency (EMA) issued a qualification opinion following a request concerning proprietary eSource DDC (Direct Data Capture) technology. This technology allows the...

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Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit

On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK...

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