EMA's safety monitoring plan for COVID-19 vaccines
- PDF / 151,796 Bytes
- 1 Pages / 595.245 x 841.846 pts (A4) Page_size
- 53 Downloads / 131 Views
1
EMA’s safety monitoring plan for COVID-19 vaccines The European Medicines Agency (EMA) and national competent authorities (NCAs) in EU Member States have published a safety monitoring plan for COVID-19 vaccines, which outlines how relevant new information which becomes available after the authorisation and uptake of COVID-19 vaccines during the COVID-19 pandemic will be collected and reviewed. According to the guidance published by the EMA and NCAs, the safety of COVID-19 vaccines will be monitored under good pharmacovigilance practices (GVP) which apply to all medicines. However, several planned activities will apply specifically to COVID-19 vaccines. "Through the implementation of these activities, the EU medicines regulatory network will assess any safety data emerging from a range of different sources (spontaneous reporting, observational studies, etc.). Any potential safety concerns identified will be addressed by taking appropriate regulatory action to safeguard individual and public health and communicating with the public in a transparent and timely manner," says the EMA. The plan requires companies to submit monthly safety reporting summaries, in addition to the regular updates, details studies for monitoring the safety, effectiveness and coverage of COVID-19 vaccines after authorisation, details transparency measures set up by EMA, and outlines how the EMA plans to engage with stakeholders. The EMA has also published guidance for companies on the preparation of risk management plans (RMPs) which are required when applying for a marketing authorisation for COVID-19 vaccines. The RMP guidance for COVID-19 vaccines complements the existing guidelines which apply to all medicines, and addresses: data on vaccine safety that might be generated after the marketing authorisation in populations such as the elderly, children, or patients with comorbidities; requirements for lists of adverse events of special interest, methods used for signal detection, and follow-up of safety signals identified in trials; submission of monthly summary safety reports by marketing authorisation holders to the EMA; and traceability tools for recording which vaccine patients have received and from which batch. For transparency, all RMPs for COVID-19 vaccines will be published on the EMA’s website. EMA. EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines. Internet Document : 13 Nov 2020. Available from: URL: 803517762 https://www.ema.europa.eu/en/news/ema-publishes-safety-monitoring-plan-guidance-risk-management-planning-covid-19-vaccines
0114-9954/20/1832-0001/$14.95 Adis © 2020 Springer Nature Switzerland AG. All rights reserved
Reactions 28 Nov 2020 No. 1832
Data Loading...
