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The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.
The European Medicines Agency (EMA) announced on Nov. 13, 2020 the publication of guidance to support preparation of risk management plans (RMPs) for COVID-19 vaccines. RMPs are submitted when companies apply for marketing authorization and explain how the company will monitor and report on the safety of a COVID-19 vaccine after authorization and how it plans to manage potential risks. The new guidance works together with existing guidelines on the RMP format in the European Union and good pharmacovigilance practices.
The new guidance provides considerations on vaccines safety in special populations such as the elderly, children, or patients with co-morbidities. It also provides core requirements for lists of adverse events of special interests, methods used for signal detection, and follow-up of safety signals found during clinical trials. The guidance states that monthly summary safety reports must be submitted to EMA in addition to periodic safety update reports. The guidance also discusses traceability tools to record who has received which vaccines from which batch.
“All activities that companies include in the RMP for a COVID-19 vaccine should take into account EMA’s infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice,” the agency stated in a press release.