International – ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic

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…