Belgium

DCT Feasibility Assessment Belgium The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Belgium in relation to Decentralized Clinical Trials (“ DCT ”). It supplements the regulations and guidance applicable to the EU and EEA described ...

2.1 Name of Regulatory Authority Federal Agency for Medicines and Health Products (“FAMHP”) The FAMHP is the Belgian competent authority in charge of ensuring the quality, safety, and efficacy of medicines and health products (medical device...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.   A list of all documents required to be submitted is provided by FAMHP. Furthermore, I...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  A single application is made under the CTIS portal for the coordinated review by EC and RA....

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   Yes . The investigator must be a doctor. See Article 36 , Law of 2017 : “ In accordance with article 49 of the [EU CTR], the in...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. Belgium has a complex regulatory framework for biobank research and its interplay with the data protection rules. There is the Law of 19 Dec 20...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . 7.2  Is there any specific regulation/ guidance on the use of DCT e...

8.1 What data privacy and/or technology regulations need to be complied with in order to run a trial in the countries of interest?   Primarily, the GDPR needs to be adhered to.  Article 93 of the EU CTR 536/2014 reads as under: “ 1...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ?   We have not been able to determine any national regulations in this r...

10.1 Clinical Trial with Investigational Medicinal Product The submission process using CTIS is described in more detail below this flow chart/roadmap: Training is to be prioritized for relevant staff in Belgium on the use of the Clinical T...

European Union EU Clinical Trial Regulation (EU CTR) 536/2014 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R0536-20220131   EMA- Questions and Answers Document Regulation (EU) 536/2014 https://health.ec.europa...

FAHMP- Part II- CTR Dossier- Site Suitability Template, updated 06 June 2023 https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.famhp.be%2Fsites%2Fdefault%2Ffiles%2Fsite_suitability_template_en_March%25202023_for%2520BE_adapted%...