For which studies does the sponsor need to be recognised as non-commercial sponsor in Belgium and how should this recognition be requested?

  • Post category:FAQ

For academic studies under the Belgian experiment law (May 7th 2004), the Clinical Trial Regulation 536/2014 or the Medical Device Regulation 2017/745, the sponsor should be recognised as non-commercial (academic) sponsor in Belgium. The following institutions are recognised as academic sponsors in Belgium:

  • Universities
  • Belgian University Hospitals
  • FWO
  • Organisations recognised by the King, published in a royal decree 

If the institution is not recognised as non-commercial sponsor, a request for recognition can be submitted. With aforementioned recognition, the institution will be able to act as academic sponsor of clinical experiments taking place in Belgium.

The request should be submitted by e-mail and should be addressed to the CEO of the FAMHP. In annex of this request, documents should be added that prove the sponsor is a non-profit institution whose primary social objective is research. These documents are for example the juridical statutes.

If applicable, proof of the request for the institution to be recognised as non-commercial sponsor should be uploaded in the Research Portal when submitting an application for a new academic clinical study.