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In brief

The European Medicines Agency (EMA) and the National Competent Authorities of the EU Member States (NCAs) have adopted the COVID-19 vaccine safety monitoring plan setting forth the methods for collecting and reviewing data obtained as a result of the marketing and administration of the new vaccines.


The plan entrusts NCAs with the task of monitoring the safety of vaccines in accordance with the EMA guidelines and of assessing the relevant safety data on the basis of available sources, including observational studies and voluntary reports. Possible safety issues will need to be addressed through the adoption of appropriate regulatory measures to safeguard human health, as well as through transparent and timely communications to the public.

In addition, the plan includes new reporting requirements for pharmaceutical companies that shall submit monthly reports and periodic updates. In this context, the EMA has also published a guide to support pharmaceutical companies in the development of risk management plans related to COVID-19 vaccines. This guidance provides important clarification on how pharmaceutical companies should monitor the safety of vaccines and report any issues that arise as a result of their marketing, as well as the steps to be taken to further qualify and manage related risks.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.