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Belgian Royal Decree on clinical trials adopted

Recently, the Belgian Government adopted a new Royal Decree regarding clinical trials (Royal Decree), which implements the law of 7 May 2017 on clinical trials with medicines for human use (Clinical Trial Law) (see our update, Belgium adopts law to prepare for Clinical Trial Regulation implementation). Both the Royal Decree and the Clinical Trial Law are aimed at the practical implementation of the EU Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR) in Belgium.

The publication of the Royal Decree marks the entry into force of new provisions (set forth by the Clinical Trial Law and the Royal Decree) with respect to:

  • The composition, recognition, functioning, and designation of ethics committees.
  • The functioning of the independent assembly (College/Collège) that will be established within the Belgian Ministry of Health.

The other provisions of the Clinical Trial Law and Royal Decree (in particular, with respect to the clinical trial authorisation application procedure, the authorisation for the manufacture of investigational medicinal products, and inspections and sanctions) will enter into force when the CTR becomes applicable which is expected to take place in 2019.

Also in relation to the application of the Clinical Trial Regulation in Belgium, the Federal Agency for Medicines and Health Products (FAMHP) has launched a call for candidates for its third wave of clinical trial pilot projects which will start in January 2018 (see our update, FAMHP issues guidance for clinical trial pilot project).

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, November 2017 Issue (Thomson Reuters).

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