Regulatory agilities and regulatory processes
During the pandemic, agilities in regulatory processes have been key to allowing safe and effective COVID-19 and non-COVID-19 related medicines and vaccines to be rapidly developed, assessed, approved, and accessed.
Extraordinary measures have been applied by National Regulatory Authorities
(NRAs) and the pharmaceutical industry to face the challenges brought by the COVID19 pandemic emergency. A variety of agilities in regulatory processes 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.
This policy briefing summarizes trends in reported experiences (from primary and
secondary research) in the use of these agilities 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 to strengthen
standard normative processes to accelerate patient access to safe and effective
medicines and vaccines.
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