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Highlights of the Safety Committee: May 2023
Highlights of the Safety Committee: May 2023
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Highlights of the Safety Committee: May 2023
Highlights of the Safety Committee: May 2023
The PRAC started a review of hydroxyprogesterone medicines and issued a reminder on the restrictions in the use of fluoroquinolone antibiotics
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End of COVID-19 public health emergency
End of COVID-19 public health emergency
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End of COVID-19 public health emergency
End of COVID-19 public health emergency
EMA's Executive Director, Emer Cooke, issues a statement after the end of the Public Health Emergency of International Concern (PHEIC) for COVID-19 was declared by the WHO.
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Revision of transparency rules for clinical trials
Revision of transparency rules for clinical trials
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Revision of transparency rules for clinical trials
Revision of transparency rules for clinical trials
EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the CTIS in the EU
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Single-arm clinical trials as pivotal evidence for the authorisation of medicines
Single-arm clinical trials as pivotal evidence for the authorisation of medicines
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Single-arm clinical trials as pivotal evidence for the authorisation of medicines
Single-arm clinical trials as pivotal evidence for the authorisation of medicines
EMA has opened a public consultation to discuss how data from single-arm clinical trials can support marketing authorisation applications for medicines in the EU
Information for you
Key content
Services & databases
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Clinical Trials website
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Account Management portal
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eSubmission
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EudraVigilance (human)
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EudraVigilance Veterinary
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Veterinary Medicines information website
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Suspected adverse drug reactions database
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Clinical data
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SPOR data management services
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Service Desk
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IRIS platform
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Public register of parallel distribution notices
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European Vaccination Information Portal