Access Consortium statement on COVID-19 medicines

The Consortium’s medicines regulators will only authorize medicines for COVID-19 if their clinical benefits outweigh their risks

14.12.2021

Vaccines have played a critical role in fighting the COVID-19 pandemic. However, medicines can still play an important role globally in treating and/or preventing COVID-19.

The medicines regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (Access Consortium) have discussed the continued need for COVID-19 medicines that are safe, effective and of high quality.

This collective statement on COVID-19 medicines builds on our May 2020 pledge to work together to counter the COVID-19 global pandemic. The statement also complements the statement on COVID-19 vaccines released in December 2020.

To provide earlier access to COVID-19 medicines that are safe and show promising efficacy or address an unmet medical need, we may consider applying available regulatory flexibilities such as emergency, temporary or conditional authorizations. However, sponsors will have to confirm the efficacy of any promising COVID-19 drugs in a timely manner and must meet the evidential standards required for a full authorization.

Together, medicines regulators and public health agencies will continually monitor the safety, effectiveness and quality of COVID-19 medicines after their authorization.