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Supporting development of medicines for childrenPaediatric |Report
Supporting development of medicines for children
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Supporting development of medicines for childrenPaediatric |Report
Supporting development of medicines for children
An EMA and European Commission report highlights improvements, such a pilot on ‘stepwise’ paediatric investigation plans for certain medicines, brought by their 2018 action plan
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Multi-stakeholder platform to improve clinical trialsClinical trials |Regulatory
Multi-stakeholder platform to improve clinical trials
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Multi-stakeholder platform to improve clinical trialsClinical trials |Regulatory
Multi-stakeholder platform to improve clinical trials
EMA, the Heads of Medicines Agencies and the European Commission are launching a public consultation on a multi-stakeholder platform aimed to improve clinical trials in the EU
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New role for EMA during public health emergenciesExtended mandate |Regulatory
New role for EMA during public health emergencies
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New role for EMA during public health emergenciesExtended mandate |Regulatory
New role for EMA during public health emergencies
Additional responsibilities for monitoring and mitigation shortages of critical medical devices during public health emergencies now apply
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CTIS now mandatory for new trial applicationsClinical trials |Regulatory
CTIS now mandatory for new trial applications
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CTIS now mandatory for new trial applicationsClinical trials |Regulatory
CTIS now mandatory for new trial applications
From 31 January 2023, all initial clinical trial applications in the European Union must be submitted via the Clinical Trials Information System (CTIS)
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List item26/01/2023
EMA update on shortages of antibiotics in the EU
EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met on Thursday to discuss the progress made and to agree on the next steps in the coordinated response to the ongoing shortages of antibiotic medicines containing...
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List item20/01/2023
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 17-18 January 2023
CVMP opinions on veterinary medicinal products Under Regulation (EU) 2019/6 The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for: Suvaxyn Circo+MH RTU Galliprant Bovela...
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List item20/01/2023
Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on shortages of antibiotic medicines
EMA, the European Commission and the Heads of Medicines Agencies (HMA) , through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , are closely monitoring and responding to current shortages of antibiotics affecting...
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List item19/01/2023
Assessment of human dietary exposure to residues of veterinary medicines in the EU
EMA and the European Food Safety Authority (EFSA) have published a joint report on the development of a harmonised approach to the assessment of dietary exposure of people to residues of veterinary medicines, feed additives and pesticides in food of...
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List item13/01/2023
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 January 2023
Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors EMA’s safety committee, PRAC has further reviewed measures to minimise the risk of serious side effects associated with Janus kinase (JAK)...
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List item21/12/2022
End-of-year message from EMA’s Executive Director
We are rapidly approaching the end of 2022 and the festive season, which for many of us is one of the most wonderful times of the year – mainly because we reunite with family and friends from near and far to celebrate, to embrace. This has become...
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