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 ...