The FAMHP is the competent authority responsible for the quality, safety and efficacy of medicines and health products. We work together with health professionals and other competent authorities at the national and international level to ensure the population the optimal use of the medicines and health products they need.
On the following webpage you can find back the webpage links to our national Innovation office and our specific national scientific-technical/regulatory advice services.
https://www.famhp.be/en/human_use/medicines/medicines
The following types of questions can be sent to the 3 mailboxes that are managed by our Innovation Office:
- sta-wta@fagg-afmps.be : Questions related to national technical/regulatory advice (eg. procedure info, specific or practical questions in view of preparing a national STA request or when to best seek national versus EU Sci advice, FAQs, etc), submissions for national STA request or simultaneous national sci advice (SNSA) requests from the FAGG
- innovationoffice@fagg-afmps.be : submissions for requesting a Project Info Meeting (PIM) request or a Portfolio meeting from the FAGG, general Questions related to clinical research and innovation in BE/EU (eg. FAQs, questions about where to find guidelines from FAGG; EMA; ICH, etc,
- sta.meddev@fagg-afmps.be : Submissions for Notified Body consultations under the MDR / future IVDR, (future) future submissions for national STA request related to medical devices/IVDs (not implemented yet !) , general Questions related to (pre)clinical development of medical devices and where to find the guidelines, etc.
