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Belgium adopts law to prepare for Clinical Trials Regulation implementation (Allen & Overy)

On 20 April 2017, the Law on clinical trials with medicines for human use was adopted to ensure the practical implementation of the EU Clinical Trials Regulation (CTR) in Belgium. The law aims at strengthening Belgium’s position at the forefront of medical research within the EU (Belgium is preceded only by Denmark in terms of the highest number of clinical trials per inhabitant).

The law will enter into force once the CTR becomes applicable, which is currently estimated to be around November 2018. For any experiments that fall outside of the scope of the CTR, such as non-interventional studies, the current law on experiments on humans dated 7 May 2004 will remain applicable.

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2017-05-12T15:07:10+00:00 12 mai, 2017|Categories: Droit médical - Pharma & lifesciences|Tags: , |