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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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Update on shortages of antibiotics in the EUShortages |Antibiotics
Update on shortages of antibiotics in the EU
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Update on shortages of antibiotics in the EUShortages |Antibiotics
Update on shortages of antibiotics in the EU
EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) discussed progress in the response to amoxicillin shortages
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New CAT Chair electedCommittees |Regulatory
New CAT Chair elected
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New CAT Chair electedCommittees |Regulatory
New CAT Chair elected
At its January meeting, EMA’s Committee for Advanced Therapies (CAT) elected Dr. Ilona Reischl from the Austrian Medicines and Medical Devices Agency as its new Chair
Latest news
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List item31/01/2023
Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU
From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). CTIS is now the single-entry point for sponsors and regulators of clinical trials for the...
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List item27/01/2023
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023
Four new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended granting a marketing authorisation for Sotyktu (deucravacitinib) for the treatment of moderate to severe plaque psoriasis in adults, a skin disease...
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List item26/01/2023
EMA Committee for Advanced Therapies elects Ilona Reischl as its new Chair
At its January 2023 meeting, EMA’s Committee for Advanced Therapies (CAT) elected Ilona Reischl from the Austrian Medicines and Medical Devices Agency (AGES MEA) as its new Chair for a three-year mandate. Before becoming Chair, Dr Reischl served as...
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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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