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]

EMA, in close collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their intended clinical development strategy and proposals for clinical investigation.

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 ...

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

This website contains clinical data published under the European Medicines Agency (EMA) policy on the publication of clinical data. The clinical data have been submitted by pharmaceutical companies to support their marketing applications for human medicines under the centralised procedure and have been assessed by the Committee for Human ...