In view of the large number of COVID-19 vaccines and treatments under development, and their potentially imminent roll-out, the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) have joined forces to uphold and promote the most rigorous, evidence-based regulatory practices by supporting the alignment of regulatory processes across all countries. As in other areas of the pandemic response, multilateral cooperation between regulatory authorities will be critical in ensuring there is a level playing field, that COVID-19 vaccines and medicines are safe, effective and quality-assured, and that all countries may benefit from such products equitably and at the same time. This joint statement commits each organization to a series of actions to make this happen.
- ICMRA and WHO continue to join forces in collaborating to address the unprecedented global health challenges related to COVID-19 pandemic, affecting so many people in the world.
- These challenges are best addressed by working together to ensure existing rigorous scientific standards of review and oversight are maintained, while still giving patients access to safe and effective medical products at the earliest time possible
- Regulatory authorities for medical products, including medicines and vaccines, have the responsibility to approve quality assured, safe and effective products based on robust and reliable data.
- The regulatory approval should be based on an independent scientific assessment of the balance of benefits and risks.
- Robust and reliable data on efficacy and safety to support market approval of medicines and vaccines are best collected through randomized controlled clinical trials which control for bias, meet Good Clinical Practice standards, respect the rights, autonomy and safety of clinical trial participants, and can be audited.
- To ensure patients have fast access to safe and effective medicines and vaccines, WHO and ICMRA, together with other stakeholders including public health institutions, are committed to the following actions: