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Clinical trial information system reaches major milestoneClinical trials |CTIS
Clinical trial information system reaches major milestone
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Clinical trial information system reaches major milestoneClinical trials |CTIS
Clinical trial information system reaches major milestone
EMA’s Management Board confirms CTIS, one of the main deliverables of the Clinical Trial Regulation, is on track to go live by 31 January 2022.
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Outcome of the PRAC review of COVID-19 Vaccine JanssenCOVID-19 |Vaccines
Outcome of the PRAC review of COVID-19 Vaccine Janssen
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Outcome of the PRAC review of COVID-19 Vaccine JanssenCOVID-19 |Vaccines
Outcome of the PRAC review of COVID-19 Vaccine Janssen
EMA’s safety committee (PRAC) finds possible link to very rare cases of unusual blood clots with low blood platelets but overall benefit-risk remains positive
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EMA continues to monitor COVID-19 vaccine AstraZenecaCOVID-19 |Vaccines
EMA continues to monitor COVID-19 vaccine AstraZeneca
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EMA continues to monitor COVID-19 vaccine AstraZenecaCOVID-19 |Vaccines
EMA continues to monitor COVID-19 vaccine AstraZeneca
EMA to provide further context on risk of very rare blood clots with low blood platelets that occurred after vaccination with Vaxzevria
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Development, evaluation and monitoring of COVID-19 vaccinesCOVID-19 |VACCINES
Development, evaluation and monitoring of COVID-19 vaccines
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Development, evaluation and monitoring of COVID-19 vaccinesCOVID-19 |VACCINES
Development, evaluation and monitoring of COVID-19 vaccines
Read about how EMA is ensuring vaccines for COVID-19 meet the highest standards of quality, safety & efficacy while their development and approval is sped up due to the public health emergency.
Latest news
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List item23/04/2021 COVID-19
EMA working on COVID-19 during closure on 27 April 2021
Although the European Medicines Agency's (EMA) offices will be closed from 18:30 on Monday 26 April until 07:30 on Wednesday 28 April 2021, remote working is still being enabled. All work related to the COVID-19 pandemic will continue during this...
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List item21/04/2021
Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation
EMA’s Management Board confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trial Regulation and the key component of the Clinical Trial Information System (CTIS), is now fully functional and on...
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List item20/04/2021 COVID-19
COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
EMA confirms overall benefit-risk remains positive At its meeting of 20 April 2021, EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19...
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List item16/04/2021
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 April 2021
CVMP opinions on veterinary medicinal products The Committee adopted by consensus positive opinions for type II variation applications concerning quality-related changes for: Comfortis (grouped variations) Purevax Rabies Purevax RCP FeLV, Purevax...
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List item15/04/2021 COVID-19
EMA starts review of VIR-7831 for treating patients with COVID-19
EMA is reviewing currently available data on the use of the monoclonal antibody VIR-7831 (also known as GSK4182136) in the treatment of patients with COVID-19. EMA is starting this review to support national authorities who may decide on the use of...
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List item14/04/2021 COVID-19
AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets
EMA continues to monitor very rare blood clots with low blood platelets that occurred after vaccination with Vaxzevria (previously COVID-19 Vaccine AstraZeneca) . In line with a request from the EU’s Commissioner for Health and Food Safety following...
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Account Management portal
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eSubmission
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EudraVigilance (human)
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