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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
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Management Board ad-hoc meeting on CTISManagement Board |Highlights
Management Board ad-hoc meeting on CTIS
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Management Board ad-hoc meeting on CTISManagement Board |Highlights
Management Board ad-hoc meeting on CTIS
Updates on recent improvements to the Clinical Trials Information System (CTIS) and progress made ahead of the mandatory use of the system from 31 January
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Implementation of the Clinical Trials RegulationClinical trials |Regulatory
Implementation of the Clinical Trials Regulation
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Implementation of the Clinical Trials RegulationClinical trials |Regulatory
Implementation of the Clinical Trials Regulation
On 31 January 2023, the Clinical Trials Information System (CTIS) will become mandatory for all authorisation applications for a clinical trial in the EU
Latest news
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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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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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Clinical Trials website
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Account Management portal
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eSubmission
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Veterinary Medicines information website
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