The European Medicines Agency is a decentralised agency of the European Union responsible for the evaluation, supervision and safety monitoring of medicines.

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). [4] [5]

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU). It is responsible for the scientific evaluation, supervision and safety monitoring of medicines.

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.

It builds on the longstanding cooperation between EMA and HTA bodies, developed with the European Network for Health Technology Assessment (EUnetHTA) until September 2023. date: ... In the EU, after a medicine is authorised the Member States take decisions about the use, price and reimbursement level in the national healthcare systems. This ...

ESMP enables information exchange for prevention, identification, and management of shortages to ensure medicines are available for patients in the EU and EEA. Create and manage your EMA account. Instructions on how to navigate ESMP for the purpose of shortage reporting.

Jan 27, 2025 · As part of EMA’s ongoing engagement efforts with IRIS users the regulatory procedure management team conducted a survey in 2024. The results suggest a majority of industry users are new to the system and not existing users. Prospective users seem to have been able to find their way to the various webinars about IRIS and they have bene able to ...

Dec 19, 2024 · Co-authored by EMA oncology staff, this article aimed to evaluate the type and number of uncertainties described in the benefit-risk assessment for initial marketing authorisations of oncology medicines assessed by the EMA in the view to develop a systematic classification of uncertainties to contribute to improved communication about uncertainties.

1 day ago · Berlin, February 10, 2025 – Bayer has submitted an application to the European Medicines Agency (EMA) to expand treatment intervals of up to 6 months with Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) …