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Expediting marketing authorisation pathways

In parallel with the centralised procedure which is the standard marketing authorisation pathway for Advanced Therapy Medicinal Products within the European Union, several mechanisms have been developed to expedite access to new medicines, including ATMPs. While maintaining a high assessment of the quality, safety and efficacy of these medicines regarding the benefit-risk balance, these mechanisms should be less time-consuming and expensive than the standard procedure.

In this section, we are presenting the formal legal alternatives to the standard marketing authorisation. On the one hand, three legal procedures to accelerate access to the market for products subject to centralized authorisation, here ATMPs, have been established by EU Regulation (EC) 726/2004: conditional marketing authorisation, marketing authorisation under exceptional circumstances, and accelerated assessment.
On the other hand, European Union law also permits the authorisation of ‘similar biological medicinal products’, also known as ‘biosimilars’, on the basis of abbreviated marketing authorisation applications, like generics. This regulatory pathway is applicable to biosimilar ATMPs.


Published: 17/01/2023

Authors: Luc-Sylvain Gilbert, EuroGCT ELSI Legal Information Officer

and Aurélie Mahalatchimy, EuroGCT WP4 Convenor 

Under internal review by EuroGCT Commercialisation Working Group.