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 care products (i.e. medical devices and accessories, in-vitro diagnostics (including companion diagnostics), raw materials, blood and blood products of human origin, human tissue material), for human and veterinary use, in clinical development and on the market. The FAMHP works together with e.g. academia, (university) hospitals, SME’s, the pharmaceutical and medical devices industry and other concerned industries, healthcare professionals, patient organisations other national, European and worldwide authorities, as well as policy makers, in order to provide everybody with the necessary medicines and health care products and to help patients and citizens to use them correctly. As part of the EU regulatory network, one of the FAMHP’s key missions is to facilitate the translation of innovative scientific advances into new medicines and health care products meeting adequate standards and by doing so to accelerate patients’ access to promising therapies fulfilling unmet medical needs without jeopardising the safety of the patients.