CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation application for a vaccine that is effective…
International regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine strain updates that was organised by the International Coalition…
The PRAC has concluded that the available evidence does not support a causal association between the Glucagon-Like Peptide-1 receptor agonists (GLP-1) – dulaglutide, exenatide,…, Agenda Agenda of the PRAC meeting 8-11 April…
During this time, EMA will load nationally and centrally authorised product data to its Product Management Service (PMS) database. This is a crucial step in making structured and…
The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will…
Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.Please note that this is an emergency number and should…
EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024.…
EMA annual report 2023 The Board adopted EMA’s annual report for 2023. In 2023, EMA recommended 77 medicines for marketing authorisation for human use, 39 of which had a new…
12 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting.The CHMP recommended granting a…, Positive recommendations on new medicines ,…
The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the…, The establishment of the multi-stakeholder platform is an…
CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation for Divence Tetra from Laboratorios Hipra,…
EMA’s safety committee (PRAC) concluded that there was insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases…, Agenda Agenda of the PRAC meeting 4-7 March 2024DraftFirst…
The Data Analysis and Real World Interrogation Network DARWIN EU will continue working towards higher capacity for real-world data (RWD) studies and seeks to add ten new data…
10 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting.The committee adopted positive…, Positive recommendations on new medicines , CelldemicCommon…
Taking a One Health approach, which recognises the connection between the health of people and animals, the report presents data primarily collected between 2019 and 2021 on…, Increased efforts to reduce unnecessary antibiotic consumption…
CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation application for Alcort (hydrocortisole aceponate…
The catalogues help medicines regulators, researchers and pharmaceutical companies to identify the most suitable data sources to address specific research questions and support…
EMA’s safety committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with Paxlovid (nirmatrelvir, ritonavir) when…, Agenda Agenda of the PRAC meeting 5-8 February 2024DraftFirst…
The aim is to guide non-commercial developers of promising ATMPs addressing unmet medical needs through the regulatory and scientific requirements in the European Union (EU) and…
All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025. This date marks the end of a three-year transition…
On 24 January 2024, the CMDh1 endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines. These…
Three new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.The committee recommended…, Positive recommendations on new medicines, Exblifep…
This medicine is used for treating patients with Duchenne muscular dystrophy whose disease is caused by a type of genetic defect called a ‘nonsense mutation’ in the dystrophin…
EMA has published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines.In 2023, EMA recommended 14 medicines…
The revised user guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorisation of medicines…, Related documents User guide for micro, small and medium…
CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive opinion for a grouping of variations requiring assessment for Metacam (meloxicam), from…
The Agency recommended two vaccines to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV), and the first advanced therapy medicinal…
EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines. These measures are to address a potential…, Agenda Agenda of the PRAC meeting 8-11 January 2024DraftFirst…
EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines. These measures are to address a potential…
Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.Please note that this is an emergency number and should…