The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a virtual meeting of regulators from around the world on 14 May 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.

Keypoints:

  • 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.
  • regulatory considerations in relation to exploratory clinical trials and pivotal studieswith investigational or repurposed medicines for the treatment of COVID-19.
  • ICMRA members also exchanged information about high-level regulatory flexibilities and extraordinary measuresapplied 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 (ICUs)and personal protective equipment (PPE) 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, while ensuring a high level of quality, safety and efficacy of medicines around the world

For more details, please see the press release from the European Medicine Agency.

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Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials: