EMA: Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
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.
Meditrial can help – Contact us for immediate support
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
