Initiatives in Belgium

Webpages: 

• Scientific-Technical advice
• Innovation office
• Dedicated webpage : Specific support to SME and academics
• National provisions for SMEs

Contact:

• innovationofficefagg-afmps [dot] be (innovationoffice[at]fagg-afmps[dot]be)  (for innovation support and regulatory inquiries).
• stafagg-afmps [dot] be (sta[at]fagg-afmps[dot]be) (for medicinal and borderline products for human/vet use)
• sta [dot] meddevfagg-afmps [dot] be (sta[dot]meddev[at]fagg-afmps[dot]be) (for drug-device combination products or medical devices or IVD’s used in conjunction with medicinal products)

Reduced fee for non-commercial sponsors by default.

Zero fee (for commercials and non-commercials) if a clinical trial is submitted for Belgium with 2 years.

• General e-mail address for all questions on clinical trials: ct [dot] rdfagg-afmps [dot] be (ct[dot]rd[at]fagg-afmps[dot]be)
• Webpage dedicated to CTR/CTIS, including regulatory and ethics requirements (content of a CTR dossier for a clinical trial): EU Regulation 536/2014

Shorter timelines for all phase I mono-national trials as stated in article 22 of the law of 7 May 2017 on clinical trials

• Principle of zero fee (national financing) at submission of the dossier, also applicable for commercial trials;
• However, GCP and safety surveillance have a fee in case of commercial and not in case of non-commercial (article 47 of the law of 7 May 2017 on clinical trials);
• Legal basis and more details on fees (including inspections fee) available in the document: Retribution & contributions AFMPS – DEMANDE D’AVIS SCIENTIFIQUE-TECHNIQUE (AST) NATIONAL (fees for 2024)

KCE Trials investigator-led calls