Global Regulators Plan Policy and Regulatory Requirements in COVID-19 Response

The International Coalition of Medicines Regulatory Authorities (ICMRA), a voluntary, executive-level entity of worldwide medicines regulatory authorities set up to provide strategic coordination, advocacy and leadership, convened a virtual meeting of regulators globally on May 14, 2020 to discuss high-level policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic. The strategic meeting underlined the need and commitment by global regulators to cooperate and align their approaches to clinical trial management, medicine supply issues, and pharmacovigilance in light of the medical emergency presented by COVID-19.

The discussion was moderated by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA). This was the third in a series of bi-weekly ICMRA meetings organized to allow medicine regulators worldwide to exchange information and build synergies for expediting COVID-19 medicine and vaccine development and approval and for preventing and mitigating medicine shortages. These strategic discussions build on the knowledge and experience gained from the series of ICMRA workshops on COVID-19 medicine development held in March and April 2020. The European Medicines Agency (EMA) and the FDA are taking turns to chair these meetings.

Participants discussed COVID-19 clinical trials, in particular the use of master protocols, around the world to accelerate the development and approval of potential treatments and vaccines against coronavirus disease. The World Health Organization (WHO) shared insights into the Solidarity Trial, which aims to compare multiple treatment options against standard of care in different countries with plans to enroll patients with COVID-19 across more than 100 countries. There is broad agreement among regulators that such large multi-center, multi-arm clinical trials need to be prioritized because they are most likely to generate the robust evidence needed to enable rapid assessment and authorization of COVID-19 therapeutics and vaccines.

In addition, participants discussed regulatory considerations in relation to exploratory clinical trials and pivotal studies with investigational or repurposed medicines for the treatment of COVID-19. They raised concerns about the growing number of underpowered clinical trials and observational studies, which compete for essential resources and patients, and might not generate the conclusive evidence needed to draw firm conclusions on the safety and efficacy of medicines intended to treat or prevent COVID-19. ICMRA members stressed the need for stringent regulatory requirements for COVID-19 studies and agreed to provide further guidance on the prioritization of clinical trials and on serology in order to promote a harmonized approach.

ICMRA members also exchanged information about high-level regulatory flexibilities and extraordinary measures applied to address some of the constraints posed by the pandemic. They emphasized that the uninterrupted supply of medicines used for the treatment of COVID-19 patients in intensive-care units and personal protective equipment is of critical concern. Regulators committed to continuously monitor and exchange information on the impact of COVID-19 on medicine supply chains to prevent and mitigate shortages.

COVID-19 observational research
In a separate development, the ICMRA has agreed to three priority areas for cooperation on observational research during the COVID-19 pandemic. They will collaborate on pregnancy research, on medicines used in clinical practice, and on vaccine safety and effectiveness monitoring.

At a second workshop on observational studies of real-world data generated during clinical practice in the context of COVID-19, co-organized by the EMA and Health Canada under the umbrella of the ICMRA international regulators agreed this week (May 19, 2020) to step up their cooperation in the following three areas:

  • Pregnancy research to examine the impact of both coronavirus disease and medication use on pregnant women infected with SARS-CoV-2 and on their unborn babies in order to support COVID-19 medicine development, risk management, and planning for safety monitoring of vaccines and therapeutics;
  • Building international clinical cohorts of COVID-19 patients to share expertise and increase study power and data quality in order to meet regulatory requirements and address existing knowledge gaps; and
  • Preparing strong infrastructure for monitoring the safety and effectiveness of vaccines against COVID-19 in order to rapidly detect and minimize risks to patients.

Meeting participants agreed that global collaboration on observational studies of real-world data will help not only to contribute to the COVID-19 response but also to provide future international observational research beyond the ongoing pandemic.

The meeting built upon the experience and knowledge gained from the first workshop on COVID-19 observational research held in April (April 2020), which underlined the need and commitment by regulators to cooperate and improve information-sharing globally in relation to the research and development of treatments and vaccines against COVID-19. It had participants from more than 25 countries, representing 28 medicines regulatory authorities and experts from the World Health Organization.

Source: European Medicines Agency (ICMRA policy workshop) and European Medicines Agency (observational research workshop)

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