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EMA Management Board: highlights of June 2024 meeting. Board adopts Executive Director’s annual activity report for 2023 and hears updates on implementation of new fee regulation. 14 June 2024. Two new advice pilots to improve clinical trials in Europe. Pilots are part of ACT EU collaboration to foster high-quality clinical research in the EU.
The European Medicines Agency (EMA) facilitates development and access to medicines for countries within the European Union (EU). EMA evaluates applications for marketing authorisation submitted via the centralised procedure, monitors the safety of medicines across their lifecycle and provides information to healthcare professionals and patients.
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
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The European Medicines Agency (EMA) protects and promotes human and animal health by evaluating and monitoring medicines within the European Union (EU) and the European Economic Area (EEA). What it does. The Agency's main responsibilities are authorising and monitoring medicines in the EU.
Documents providing officially approved information for healthcare professionals and patients on a medicine. The product information includes the summary of product characteristics, package leaflet and labelling.
Nov 30, 2021 · The EU is prepared to tackle ongoing pandemic challenges, says EMA chief. Health MEPs quizzed the EMA’s Executive Director on Tuesday on the current situation around COVID-19 vaccines and therapeutics, as well as the Agency’s future role.
May 30, 2024 · EMA is the first regulatory authority worldwide to provide such broad access to clinical data. For more information on the clinical data on this website, see Clinical data available. For more information on EMA and its policy on the publication of clinical data, see the EMA corporate website.
The HMA-EMA Catalogues are repositories of metadata collected from real-world data (RWD) sources and RWD studies. They are intended to help regulators, pharmaceutical companies and researchers to identify and use such data when investigating the use, safety and effectiveness of medicines.
All vaccines must go through several stages of testing to ensure they are safe, and effective before being approved for use in the EU. It must undergo rigorous testing by its developer before a scientific evaluation by regulatory authorities, including the European Medicines Agency (EMA) and regulators in individual EU/EEA countries.
