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Belgium: Covid-19 – Coronavirus: updated guidance on managing clinical trials during pandemic
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On April 2020, the Belgian government updated its Guidance on the management of clinical trials during the Covid-19 coronavirus pandemic, in line with the development of the Covid-19 pandemic.
The guidance was initially issued on 25 March 2020, following EU guidance of the same name (see our previous post here). The Belgian guidance supplements EU guidance and provides more detail for clinical trial sponsors in the management of clinical trials for the prevention or treatment of Covid-19 and other ongoing clinical trials in Belgium.
The updated guidance includes:
- Slight changes in procedure and communication with authorities. For national Covid-19-related interventional trials, the accelerated CTR Pilot Project procedure is "strongly recommended". Sponsors are still invited to consider the accelerated Voluntary Harmonisation Procedure when submitting a multi-country Covid-19-related trial. All other submissions to the Federal Agency for Medicines and Health Products (FAMHP) should be done exclusively electronically via CESP.
- New guidance on "shipment from the site to the patient". Direct shipment from sponsor to patient is not allowed in Belgium. However, the new version of the guidance allows an agreement to be set up with a courier service so that, during the pandemic, the site personnel can use this service when needed to ship investigational medicinal product to the patient's home. The guidance sets out strict conditions that must be adhered to.
- A new "Annex 2", which contains a set of frequently asked questions and corresponding answers, covering various issues including, among other things: priorities (no prohibition on submitting applications for new non- Covid-19-related trials), procedure (for example, timelines and when to contact the ethics committee and the FAMHP when submitting a COVID-19 trial application), informed consent, temporary halts and urgent safety measures, risk assessment, restrictions of visits to healthcare facilities, compliance with certain aspects of the General Data Protection Regulation ((EU) 2016/679), and contract management templates.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, July 2020 Issue (Thomson Reuters).