The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have reviewed some of the practices applied by regulatory authorities worldwide to respond to the challenges faced during the COVID-19 pandemic.
In the context of COVID-19, regulatory authorities have adapted some of their regulatory frameworks and streamlined their procedures while ensuring a high level of quality, safety and efficacy of the medicinal products made available to patients around the world. The measures aimed at addressing the urgent need for medicines and vaccines to tackle COVID-19 but also at dealing with the constraints posed by the pandemic, e.g. travel restrictions or lockdowns. The report now published by the two organisations features concrete examples of regulatory flexibilities and extraordinary measures that have been put in place in different areas of medicines regulation, including:
- clinical trial oversight;
- registration and marketing authorisation;
- inspections (good manufacturing practice (GMP), good clinical practice (GCP), good distribution practice (GDP)/import & export, good laboratory practice (GLP));
- post-authorisation activities and pharmacovigilance;
- facilitating access and managing shortages of medicines;
- medical devices (including personal protective equipment (PPE)) and sanitisers.
The ICMRA workshop on enabling manufacturing capacity in the COVID-19 pandemic, which was held in July 2021, is a concrete example of how regulators are looking to respond to the ongoing public health needs.
As a next step, global regulators are encouraged to share their experiences and exchange information concerning the effectiveness of the regulatory flexibilities they have applied during the pandemic. It is expected that this feedback will help to identify best practices for future public health crises and, where appropriate, even normal regulatory activities.
The report was developed following a review exercise conducted by ICMRA members and WHO experts, and a series of discussions on strategic issues and regulatory flexibilities to enhance the efficiency and effectiveness of regulatory decision-making during the current pandemic.
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