Find information on centrally authorised medicines. Find all new and updated information published on our website in one place. Find answers to the most frequent asked questions we receive. Eco-Management and Audit Scheme (EMAS) certificate is a mark of environmental excellence 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). [4] [5]

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.

This complements information on medicines published on this website, which only includes medicines that the European Medicines Agency (EMA) evaluates. Some of these registers cover both human and veterinary medicines. To learn more about the different medicine authorisation routes in the EU, see:

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). The Agency's main responsibilities are authorising and monitoring medicines in the EU.

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 …

The European Medicines Agency (EMA) is an agency of the European Union. It manages the evaluation and quality of pharmaceutical products. It started in 1995.

4 days ago · EMA and the Heads of Medicines Agencies (HMA) are warning the public about the dangers of unregulated advanced therapy medicinal products (ATMPs) offered to patients in the European Union.. ATMPs are medicinal products that are based on genes, tissues or cells. When these medicines are regulated (i.e. authorised via EMA or approved by a national authority), they can offer important benefits ...

These three words signify the mission of EMA: to make science-based decisions, to regulate medicines, and to promote human and animal health. EMA has a similar role as FDA in the review and...

The Food and Drug Administration (FDA) and European Medicines Agency (EMA) now have expedited review procedures for new drugs. We compared the review times of medicines licensed by the 2 agencies and explored differences in the evidence submitted. ...

Per the 2019 EMA annual report, 90% of the medicines, mainly generic drugs, entering the EU market were approved through the national, mutual, or decentralized process.

MAs for medicines approved for Covid-related indications in the first two pandemic years (March 2020–February 2022) were identified using the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) websites.

Mar 5, 2025 · The EMA offers a unified European approval system, while the FDA enforces a country-specific, stringent process. Successfully navigating these differences is essential for companies looking to expand into international markets.

EMA does not have a role in the authorisation of clinical trials in the EU; this is the responsibility of the national competent authorities. However, EMA, in cooperation with the EU Member States, plays a key role in ensuring that medicine developers follow EU and international standards.

Log into your EMA account. Select Dashboard. Find your active applications for your student(s) under My Applications. You can either view the Application Status list or select VIEW ALL → to review every application for a particular program and the application status(es) of your student(s).

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EMA's main responsibility is the protection and promotion of public and animal health, by carrying out scientific evaluations of medicines for human and veterinary use. The outcome of EMA's evaluation is used by the European Commission to decide whether a medicine can be authorised for marketing in the European Union (EU).

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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.