EMA guidance on risk management plans for COVID-19 vaccines reviewed
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EMA guidance on risk management plans for COVID-19 vaccines reviewed EMA guidance for pharmaceutical companies on how to prepare risk management plans (RMPs) for COVID-19 vaccines have been reviewed by the PRAC,* says the agency. According to highlights from the PRAC’s recent October 2020 meeting, "companies are required to submit an RMP for COVID-19 vaccines when they apply for a marketing authorisation", noted the EMA. Any such RMP should explain how the market licensee of any COVID-19 vaccine "must monitor and report on its safety, and what measures they must put in place to manage any risks", noted the EMA. The agency also highlighted that as new information becomes available, RMPs are updated continuously across the lifetime of a vaccine. The revised guidance is intended for COVID-19 vaccines only, and complements existing RMP format guidelines in the EU that apply to all medicines. This guidance will now be sent to the EMA’s Committee for Medicinal Products for Human Use, and it will be made available publicly once adopted by this committee. * PRAC = Pharmacovigilance Risk Assessment Committee European Medicines Agency. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 October 2020. Internet Document : 30 Oct 2020. Available from: URL: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-26-29-october-2020 803516318
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Reactions 14 Nov 2020 No. 1830
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