WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines

Working to prioritise well-designed clinical trials that will provide robust and reliable results.

Ensuring that there are meaningful and scientifically sound endpoints and safety data of sufficient duration in clinical trials;

Sharing data between regulators in real time to facilitate multi-country approvals;

Putting in place processes and policies utilizing the principles of regulatory agility by ICMRA members and WHO member states, providing an agile and rapid response to the global emergency;

Committing to full transparency of clinical trial results to support regulatory decisions, as well as ensuring public trust in authorities and confidence in vaccines

Working together to prevent and/or mitigate shortages of critical medicines and vaccines;

Continue working together once these COVID-19 therapies and vaccines are authorized and used to monitor their use, and identify, communicate and mitigate any safety or efficacy issues which may arise;

Reduce the risks associated with unproven treatments, potentially fraudulent and false claims, which endanger patients’ lives.

 

https://www.who.int/news/item/06-11-2020-who-icmra-joint-statement-on-the-need-for-improved-global-regulatory-alignment-on-covid-19-medicines-and-vaccines