News

Last weeks round-up; 25 – 29 November 2019

published 3 Dec 2019

EMA ACCELERATED ASSESSMENT MARKETING AUTHORISATION APPLICATIONS

EMA has updated their pre-authorisation procedural advice guidance to strongly recommend taking the pre-submission opportunities to discuss the completeness of the data package supporting a marketing authorisation application and the scientific and regulatory support offered by the PRIME scheme. Similarly, all applicants are encouraged to discuss the content of the dossier with the (Co-)Rapporteurs and the Agency prior to the submission. A tracked changes document clearly indicates the updates to the guidance document (https://lnkd.in/dwqbMrD)