EMA – Publication of a Questions and Answers on the ‘OPEN’ Framework
International collaboration brings multiple benefits to regulatory authorities, and eventually to patients. It facilitates patient access through harmonisation or convergence, brings additional scientific expertise to the regulatory process, and simplification for the pharmaceutical industry.
EMA began a pilot in December 2020 to increase international collaboration and share scientific expertise on the evaluation of COVID-19 vaccines and therapeutics. All COVID-19 vaccines and therapeutics evaluated since the launch of the pilot have been assessed under the OPEN framework, from the moment the rolling review started to the evaluation of the marketing authorisation application. Regulators from Australia, Canada, Japan, Switzerland, and the World Health Organization participated in the pilot.
Following the positive outcome of the pilot, the framework has been extended to other therapeutic areas. The following Q&A explains the principles of this collaboration.
More information on the OPEN Initiative on the EMA Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (19 octobre 2024). EMA – Publication of a Questions and Answers on the ‘OPEN’ Framework. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/12ja7





