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Highlights of the Safety Committee: May 2023
MEDICINES |COMMITTEESHighlights of the Safety Committee: May 2023
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Highlights of the Safety Committee: May 2023
MEDICINES |COMMITTEESHighlights 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
COVID-19 |StatementEnd of COVID-19 public health emergency
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End of COVID-19 public health emergency
COVID-19 |StatementEnd 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
Clinical Trials |Public consultationRevision of transparency rules for clinical trials
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Revision of transparency rules for clinical trials
Clinical Trials |Public consultationRevision 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
Clinical trials |RegulatorySingle-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
Clinical trials |RegulatorySingle-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
Latest news
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List item12/05/2023
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 12 May 2023
Review of hydroxyprogesterone started EMA has started a review of medicines containing hydroxyprogesterone following concerns about the safety and effectiveness of these medicines. In the EU, these medicines are available as hydroxyprogesterone...
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List item12/05/2023
Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling and potentially irreversible side effects
EMA’s safety committee, PRAC, is reminding healthcare professionals that the use of fluoroquinolone antibiotics, given by mouth, injection or inhalation, is restricted due to the risk of disabling, long-lasting and potentially irreversible side...
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List item10/05/2023 COVID-19
EMA and European medicines regulatory network lift COVID-19 business continuity status
EMA and the European medicines regulatory network are lifting their respective COVID-19 business continuity measures after successfully handling the unprecedented operational challenges posed by the pandemic. This was foreseen in EMA’s workplan for...
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List item08/05/2023 COVID-19
Statement from Emer Cooke on the end of the COVID-19 public health emergency
On Friday, the WHO Director General declared an end to the Public Health Emergency of International Concern (PHEIC) for the disease caused by the coronavirus SARS-CoV-2. I welcome this important milestone and would like to share some thoughts about...
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List item05/05/2023
EMA business hours on Europe Day, Tuesday 9 May
The European Medicines Agency's (EMA) office is closed from 18:30 on Monday 8 May until 07:30 on Wednesday 10 May 2023. Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600...
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List item03/05/2023
Review of transparency rules for the EU Clinical Trials Information System (CTIS)
EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union (EU). Stakeholders are invited to send...
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