Global regulatory authorities COVID-19 policy and regulations meeting

The International Coalition of Medicines Regulatory Authorities (ICMRA) met to discuss COVID-19 policies, regulatory aspects of COVID-19 medicine development and pragmatic approaches to address challenges posed by the ongoing pandemic.

This was the fourth in a series of bi-weekly ICMRA meetings for regulatory bodies to build strategies to expedite the development and approval of COVID-19 medical countermeasures. The authorities also discuss methods to prevent or mitigate drug shortages caused by the pandemic.

The European Medicines Agency (EMA) revealed that during the meeting participants exchanged information about the medicines that are currently under development or in clinical trials for COVID-19. It highlighted that the group said clinical trials must be adequately powered, well-designed and include a control arm with the standard of care treatment to generate the evidence needed for regulatory bodies to decide on possible approvals. The ICMRA also noted that trials – provided the safety of the participants is assured – should not be discontinued prematurely, in order for a balance to be struck between collecting the necessary evidence of efficacy and safety for decision making and expediting the development/approval of COVID-19 therapies.

The EMA also expounded on the flexible measures authorities are developing or had put in place to ensure continuity of medicine supply and regulatory oversight:

• The EMA has put in “extraordinary measures” in various areas of medicine regulation, such as inspections of manufacturing facilities, pharmacovigilance corrective and preventive action plans, audits and the validity of good manufacturing practice (GMP) certificates

• Guidance for remote good clinical practice (GCP) inspections is being developed in the EU

• Other regulators are developing strategies for virtual evaluations and remote GCP inspections.

The participants of the meeting also agreed that these measures have benefited from digital transformation of regulatory processes during the pandemic, according to the EMA.

The group also concluded that once these flexible measures have been rolled back after the pandemic, a comprehensive assessment of possible benefits of some of these adaptations in different countries would be critical.

ICMRA has also established a COVID-19 working group, who provide recommendations when concerns are raised during strategic discussions on policies and regulatory flexibility. The group is currently working on regulatory criteria for the prioritisation of COVID-19 vaccines, guidance on the prioritisation of clinical trials and the coordination of trial registries.

EMA and the US Food and Drug Administration (FDA) are taking turns in chairing these meetings.