Position paper 23 June 2022

Regulatory agilities applied to quality processes


The COVID-19 pandemic has highlighted the importance of using agilities to minimize disruptions in the global supply chain and risks of drug shortages, and to allow NRAs and manufacturers to rapidly increase manufacturing capacity for producing medicines without compromising their safety and quality.

Extraordinary measures have been applied by National Regulatory Authorities (NRAs) and the pharmaceutical industry to face the challenges brought by the COVID-19 pandemic emergency. A variety of agilities related to Quality processes have been key to allow the rapid development, assessment, approval, manufacturing, and access to safe and effective COVID-19 and non-COVID-19 related medicines and vaccines.

This policy briefing summarizes trends in reported experiences (from primary and secondary research) in the use of regulatory agilities applied to quality observed since the start of the pandemic, some reported challenges to their implementation and forward-looking recommendations, whether to prepare for the next pandemic or strengthen standard normative processes to accelerate patient access to safe and
effective medicines and vaccines.


Position paper pdf | 449KB
Our recommendations pdf | 372KB