Ema.europa.eu

Homepage European Medicines Agency

WebEMA business hours over Easter holiday period. The European Medicines Agency's (EMA) office is closed from 18:30 on Wednesday 27 March 2024 to 07:30 on Tuesday 2 April …

Actived: 7 days ago

URL: https://www.ema.europa.eu/en/homepage

National competent authorities

WebThe national competent authorities are primarily responsible for the authorisation of medicines available in the EU that do not pass through the centralised procedure.. They …

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Good manufacturing practice European Medicines Agency

WebEMA, the European Commission and Heads of Medicines Agencies (HMA) have phased out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 …

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Public health threats European Medicines Agency

WebPublic health threats. The European Medicines Agency (EMA) is committed to supporting global efforts to respond to existing and emerging public health threats, such as …

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Scientific guidelines European Medicines Agency

WebThe Agency strongly encourages applicants and marketing authorisation holders to follow these guidelines. Applicants need to justify deviations from guidelines fully in their …

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Healthcare professionals European Medicines Agency

WebThe European Medicines Agency's (EMA) office is closed from 18:30 on Wednesday 27 March 2024 to 07:30 on Tuesday 2 April 2024. Outside of working hours and on public …

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Guidance on good manufacturing practice and good distribution …

WebThis content applies to human and veterinary medicines. The European Medicines Agency's (EMA) provides answers to frequently asked questions on good manufacturing practice (GMP) and good distribution practice (GDP), as discussed and agreed by the GMP/GDP Inspectors Working Group.. The guidance provided by the working group in the form of …

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EU Member States European Medicines Agency

WebThe European Medicines Agency (EMA) works closely with the human and veterinary medicines regulatory authorities of the Member States of the European Union (EU) and …

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Safety of COVID-19 vaccines European Medicines Agency

WebSafety information. COVID-19 vaccines continue to protect people from severe disease and death caused by infection with SARS-CoV-2, the virus that causes COVID-19. …

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Meeting highlights from the Committee for Medicinal Products for …

WebEight new medicines recommended for approval. EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.

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About us European Medicines Agency

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

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EudraGMDP database European Medicines Agency

WebThis content applies to human and veterinary medicines. The EudraGMDP database is the Community database on manufacturing, import and wholesale-distribution authorisations, and good manufacturing-practice (GMP) and good-distribution-practice (GDP) certificates. A public version of the database has been available since 2011, which allows public

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Human medicines: highlights of 2022 European …

WebThe Human medicines highlights 2022 of the 2022 key recommendations published today includes figures on the authorisation of medicines and a selection of new …

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ICH E6 (R2) Good clinical practice

WebE6 (R2) Good clinical practice. - Scientific. guideline. This document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It aims to provide a unified standard for the ICH regions to facilitate

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Pharmacovigilance: Overview European Medicines Agency

WebThe Agency is responsible for developing and maintaining EudraVigilance, a system for managing and analysing information on suspected adverse reactions to medicines …

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Reporting safety information on

WebClinical trial sponsors must report information on the safety of clinical trial participants to the European Union (EU) Member States and European Economic Area (EEA) countries …

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Herbal medicinal products European Medicines Agency

WebA simplified registration procedure for traditional herbal medicinal products was introduced in 2004 through Directive 2004/24/EC (the Herbal Directive), which amends Directive …

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Clinical Trials Regulation European Medicines Agency

WebEuropean Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure the EU offers an attractive …

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The European Regulatory System for Medicines

WebThe European medicines regulatory system is based on a network of around 50 regulatory authorities from the 30 EEA countries (27 EU Member States plus Iceland, Liechtenstein …

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Good distribution practice European Medicines Agency

WebEMA, the European Commission and Heads of Medicines Agencies (HMA) have phased out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 …

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