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The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.
The European Medicines Agency (EMA) announced that the agency and national competent authorities (NCAs) in European Union (EU) Member States have prepared a safety monitoring plan for COVID-19 vaccines. The plan explains how new information that may come to light after the authorization of COVID-19 vaccines will be gathered and reviewed.
According to EMA, safety monitoring of COVID-19 vaccines will be done according to guidance issued by EMA and NCAs in the good pharmacovigilance practices that apply to all medicines. Some activities planned by EU authorities, however, will apply specifically to COVID-19 vaccines.
Under the plan, companies will have to submit monthly safety reporting summaries in addition to the updates already foreseen in the legislation. The plan also provides details on scientific studies for monitoring COVID-19 vaccines after their authorization. Transparency measures are also discussed in the plan.
“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,” EMA stated in a press release.