COVID-19: EMA is piloting a new ‘OPEN’ initiative

16 febbraio 2021 – EMA starts an initiative to increase international collaboration on the evaluation of COVID-19 vaccines and therapeutics. As the EMA stated, the pilot project has already begun in December 2020. It allows the regulatory authorities to share scientific expertise during the evaluation of COVID-19 vaccines and therapeutics. Participants of the project are the regulatory authorities of Australia, Canada, Japan, Switzerland and the World Health Organization (WHO). The participants receive helpful outputs, which include rapporteurs’ assessment reports, list of questions, reader’s guidance, joint assessment report, interim and final opinion. The participating authorities may also share their own documents with the ETF or CHMP, without prejudice to the CHMP assessment. This pilot project is limited to CHMP and ETF and not extendable to other scientific committees such as PRAC or CAT. The project is implemented within the existing legal framework, as there were already confidentiality agreements between all entities in place. Overall, the pilot shall foster better understanding of regulatory outcomes, while scientific and regulatory independence of the participating authorities shall be retained.

For further information, see here.