Apr 16, 2025 · The FAMHP, EMA and the Heads of European Medicines Agencies warn about unregulated products in the EU, including dendritic cell cancer therapies. Read more about Unregulated advanced therapy medicinal products pose serious risks to health

The Federal Agency for Medicines and Health Products (FAMHP) of Belgium is responsible for the approval and registration of new medication in Belgium and for pharmacovigilance. Hugues Malonne is the current CEO of the agency.

The Federal Agency for Medicinal and Health Products (FAMHP) is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding...

Nov 7, 2023 · Your medicine and health products. About the FAMHP; Jobs; Publications; Press; Contact; Complaints; Search

Oct 5, 2023 · Xavier De Cuyper of the Federal Agency for Medicines & Health Products (FAMHP), Belgium’s drug regulator, explains the FAMHP’s pandemic response and lessons learned, how the Agency is keeping on top of the rapidly evolving technologies being brought forward today, and the significance of a new early access programme for medicines in Belgium.

Meeting with FAMHP experts; Innovation activities; Specific support to SMEs and academics; Presentations, workshops & events; Contact; Research & Development. Clinical trials; Vigilance; Ethic committee; compassionate use - medical need; Marketing Authorisation procedures. Procedures; Procedures after the first marketing autorisation

Mar 23, 2020 · Since 2007, the Federal Agency for Medicines & Health Products (FAMHP) has been the Belgian competent authority in charge of ensuring the quality, safety, and efficacy of medicines and health products for human and veterinary use in …

The Federal Agency for Medicines and Health Products (FAMHP) is the Belgian competent authority in charge of ensuring the quality, safety and efficacy of medicines and health products (medical devices and accessories, raw materials, blood and blood products of human origin, human tissue material), for human and veterinary use, in clinical ...

The FAMHP is the competent authority in Belgium that monitors the quality, safety and efficacy of medicines and health products in clinical development and on the market, in the interests of public health.

Actors in the medical devices sector can register here. Registering on the portal allows you to : Register your activities (distributor, manufacturer, authorised representative,...) If you are already registered with the FAMHP, please login using your identity card (Belgian eID).