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How can real-world evidence support regulatory decision making?
Strategies to further accelerate real-world evidence generation to aid EU regulatory decision-making are needed, states a European Medicines Agency (EMA) report.
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Pharmacovigilance Risk Assessment Committee (PRAC)
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Dec 2021
EMA's drug safety committee (PRAC) confirmed the risks of myocarditis and pericarditis with COVID-19 messenger RNA (mRNA) vaccines.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Oct 2021
EMA's drug safety committee (PRAC) assessed risks with COVID-19 vaccines and identified no risk of death with Imbruvica and ACE inhibitors.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) assessed risks of thrombocytopenia and venous thromboembolism with the Janssen COVID-19 Vaccine.
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EMA task force established to co-ordinate rapid regulatory action for COVID-19 medicines
The COVID-19 EMA pandemic Task Force (COVID-ETF) will aid in the development, authorisation and safety monitoring of COVID-19 vaccines and therapeutics.
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EMA begins safety review of ifosfamide cancer medicines
The EMA has announced the results of its pharmacovigilance meeting for March, saying that it has started a review of medicines containing ifosfamide due to a higher risk of encephalopathy.
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EMA to review Picato after rise in skin cancer cases
The EMA will assess the marketing authorisation for the medication to see whether it is a cause of skin cancer in patients.
