EMA COVID-19 assessments ‘OPEN’ to non-EU regulators
EMA is piloting a new ‘OPEN’ initiative to increase international collaboration on the evaluation of COVID-19 vaccines and therapeutics. The pilot started in December 2020.
Information on the OPEN pilot is available in a Question & Answer document.
The collaboration allows sharing of scientific expertise during the evaluation of COVID-19 vaccines and therapeutics at a time when regulatory authorities and pharmaceutical industry are all facing common challenges. It will promote overall transparency and contribute to public trust in the vaccines and therapeutics.
The pilot will foster better understanding of regulatory outcomes, while retaining scientific and regulatory independence of the participating authorities.
Regulators from Australia, Canada, Japan, Switzerland and the World Health Organization (WHO) are participating in the pilot under the terms of existing confidentiality arrangements.
These non-EU regulators began participating and contributing to the work of EMA’s human medicines committee (CHMP) and the COVID-19 EMA pandemic Task Force (COVID-ETF) on 18 December 2020. This followed endorsement of the OPEN pilot and approval by the European Commission and EMA Management Board of the revision to the CHMP rules of procedure on 16 December 2020.