No medicine may be lawfully marketed in the European Union without marketing authorisation. For Advanced Therapy Medicinal Products (ATMPs), the standard marketing authorisation pathway is the approval process called ‘centralised procedure’.
However, three additional legal procedures also exist to accelerate access to the market for products subject to centralised authorisation, as well as regulatory programmes established by the European Medicines Agency (EMA) in order to to expedite access to medicines in Europe by assisting with the research and development processes.
Fig. 1. Country of ATMPs Marketing Authorisation (MA) holders. (last updated: February 2024) The breakdown of the country of the ATMPs’ MA holders is the following: NL 7 (27%), IE 7 (27%), BE 2 (7%), DE 2 (8%), IT 3 (8%), UK 2 (11%), USA 2 (8%), DK 1 (4%). Abbreviations: BE: Belgium; DE: Germany; DK: Denmark; IE: Ireland; IT: Italy; NL: Netherlands; UK: United Kingdom; USA: United States of America.
