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28 June 2024. Positive CHMP opinion on first-in-class medicine to treat pulmonary arterial hypertension. Winrevair received support through PRIority Medicines (PRIME) scheme due to its potential to bring a major therapeutic advantage over existing therapies. 28 June 2024.
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.
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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.
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 ).
The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein. Human Regulatory and procedural guidance.
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.
Jun 6, 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 European Medicines Agency (EMA) answers frequently asked questions (FAQs) about its work and scope. You can find these FAQs in English, but it is also possible to download translations in all European Union languages. For that, you can check the section 'Translations of this webpage' at the bottom of the page and select your preferred language.
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.
