The EMA released its revised version of the Guidance for applicants seeking access to PRIME scheme. This document provides guidance to prospective applicants to the PRIME (PRIority MEdicines) scheme, including relevant templates. More information on...
The EMA released a new factsheet summarizing the key elements of the PRIME scheme. More information on the PRIME scheme on the EMA Website.
Le bilan des procédures accélérées aux Etats-Unis, qui s’appuie sur plus de 30 ans d’expérience de la FDA, a montré que les études confirmatoires requises par la FDA ne sont disponibles que plusieurs années après leur mise...
Mis en place en 2021, le dispositif d’accès précoce permet à plus de 50 000 patients (vs 30 000 avec le mécanisme précédent d’ATU* ) par an en France** de bénéficier de traitements innovants plus...
Information on granted EAMS scientific opinions, including the public assessment report and treatment protocols. Read the updated news from Medicines and Healthcare products Regulatory Agency published on 31 May 2024.
“Mise en place le 1er juillet 2021, l’autorisation d’accès précoce permet aux patients un accès rapide remboursé à des médicaments qui ne sont pas encore autorisés ou pris en charge dans le droit commun. Ces...
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster. Read the news from Medicines and Healthcare products Regulatory Agency published on 12 January 2024.
Medicines that were granted a positive opinion under the early access to medicines scheme which has now expired. Read the decision from Medicines and Healthcare products Regulatory Agency published on 4 October 2023.
Information on granted EAMS scientific opinions, including the public assessment report and treatment protocols. Read the press release from Medicines and Healthcare products Regulatory Agency published on 5 July 2023.
The EMA made available the Application form for its pilot of enhanced support for academia and non-profit organisations. Launched in September, and open to academic sponsors and non-profit organisations developing advanced therapy medicinal products (ATMPs),...
