Policy brief: Regulatory agilities applied during COVID-19

Published on: 23 June 2022

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 in regulatory, clinical trial and quality process have been key to allow the rapid development, assessment, approval of and access to safe and effective COVID-19 and non-COVID-19 related medicines and vaccines.

Three policy briefings, based on primary and secondary research, summarize trends, observations and reported challenges in the implementation of these agilities and provide forward-looking recommendations on how to prepare for the next pandemic and to strengthen standard normative processes to further accelerate patient access to safe and effective medicines and vaccines.

On regulatory:

Policy briefing: Regulatory

Recommendations: Regulatory

On clinical trials: 

Policy Briefing: Clinical Trials

Recommendations: Clinical Trials

On quality processes: 

Policy Briefing: Quality

Recommendations: Quality