The directorate general (DG) PRE authorisation of the Federal Agency for Medicines and Health Products (FAMHP) offers applicants the possibility to request national scientific and/or technical advice (STA) related to the research and development aspects of human health products. The FAMHP’s main objective in providing STA to applicants at a national level is to promote and facilitate the development of new health products from a regulatory perspective as much as possible in order to enhance the availability of such innovations to patients, especially in therapeutic areas where there is an unmet medical need.
For this purpose the National Innovation Office and Scientific-Technical Advice unit of the DG PRE authorisation offers a centralised and transparent service within the FAMHP which should ensure the processing of STA requests in a timely fashion while assuring full confidentiality and avoiding any potential conflict of interest of the involved experts. The FAMHP also aims to provide suitable monitoring of the European scientific/technological and regulatory developments (for example, at the level of the Medical Device Coordination Group, the European Medicines Agency, Medical Devices Regulation, In Vitro Devices Regulation and Regulation on the safety and quality of substances of human origin) in order to ensure the quality and consistency of the national STA that it issues.
The Royal Decree of 12 May 2024 implements the STA on health products and advice relating to the status and classification of a product.
Any general or specific questions regarding national STA of the FAMHP concerning medical devices, in vitro medical devices (IVDs) or human body material (HBM) can be sent to the following email address: sta.meddev@fagg-afmps.be.
However, applicants are invited to consult the guidance document (see Regulations) before sending any questions to the aforementioned email address.