Global Regulators Explore Alignment Options During COVID-19
Executive Summary
Supporting convergence, allowing greater regulatory flexibility and avoiding drug shortages were among key topics discussed by global regulators at the first of a series of bi-weekly exchanges organized by the International Coalition of Medicines Regulatory Authorities.
As drug regulators around the world explore ways to deal with the COVID-19 pandemic, they have agreed to hold bi-weekly meetings to exchange information and build synergies to speed up the development and approval of medicines and vaccines, and to look at ways to avoid medicine shortages.
At the first such meeting on 16 April, organized under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), global regulators discussed ways to align their regulatory requirements and policy approaches to respond to the pandemic.
Representatives of more than 20 medicines regulatory authorities as well as experts from the World Health Organization acknowledged the importance of regulatory convergence as well as allowing flexibilities to facilitate the development, evaluation and availability of medicines to treat and prevent COVID-19 infection.
At the meeting, the regulators exchanged information on various accelerated regulatory measures implemented in different countries and agreed that regulatory rules should be applied with greater flexibility during the pandemic to facilitate development of potential COVID-19 treatments and secure continued supply of medicines.
In addition, ICMRA members stated that ensuring the continued availability of medicines, in particular those used for treating COVID-19 patients in intensive care units, was of critical concern. Different countries and regions have adopted different approaches to dealing with medicine shortages. The EU, for example, has launched a new fast-track system to monitor the availability of medicines to treat COVID-19 patients that initially focuses on medicines needed in hospital intensive care units. (Also see "EU Launches Fast-Track Monitoring Of Crucial COVID-19 Drug Shortages" - Pink Sheet, 21 Apr, 2020.)
On the development of new medicines to treat or prevent COVID-19, regulators reiterated the need to prioritize large COVID-19 clinical trials and to align common study protocols. Large randomized controlled studies are regarded as the best way to collect robust evidence to determine which investigational agents or repurposed medicines are safe and effective. (Also see "Regulators Insist On Large-Scale Trials For Coronavirus Treatment Candidates" - Pink Sheet, 9 Apr, 2020.) Regulators also said it was important to discourage the conduct of multiple underpowered studies that could compete for essential resources.