The Amendment of the German Medicinal Products Act [Arzneimittelgesetz – AMG] enters into force
The Clinical Trials Regulation, Regulation EU No 536/2014 is expected to come into application in 2019. This regulation is intended to further harmonise the approval, conduct and monitoring of clinical trials in the EU, and to replace the current Clinical Trials Directive 2001/20/EC. Since an EU regulation (unlike an EU directive) is directly applicable law in all EU member states, the German Medicinal Products Act (AMG) had to have certain rules that do not comply with the new EU Regulation removed. In addition, national regulations had to be defined for those areas in which the EU Clinical Trials Regulation still leaves the Member States some room for manoeuvre.

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If you want to learn more about the suspected fraud in clinical trials on generic drugs in India, please contact us.

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If you want to learn more about the fatal accident in a phase I clinical trial in Rennes (Frabnce) in 2016, please contact us.

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If you want to learn more about the German puplic databases on non-interventional studies, please contact us.

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If you want to learn more about the EMA guideline on publication of clinical trial reports, please contact us.