The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have committed to working together to ensure that patients have access to safe and effective medicines against COVID-19 as early as possible, while the existing rigorous scientific standards for the evaluation and safety monitoring of treatments and vaccines are maintained at all times.

“The world is looking at international regulators and WHO to safeguard public health and to coordinate agile regulatory approaches to the COVID-19 response,” said Professor Guido Rasi, Chair of ICMRA and EMA’s Executive Director. “ICMRA and WHO work closely together to jointly address the challenges related to the development, authorisation and roll-out of safe and effective medicines and vaccines against COVID-19.”

In their joint statement, international medicines regulators and WHO reiterate that therapeutics and vaccines against COVID-19 can only be rapidly approved if applications are supported by robust and sound scientific evidence that allows medicine regulators to conclude on a positive benefit-risk balance for these products. ICMRA and WHO also pledge to take concrete actions to ensure equitable access to safe, effective and quality-assured medicines for the treatment or prevention of COVID-19 around the world.

Posted on the EMA website on 6 November 2020