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Homepage European Medicines Agency

WEBEudraVigilance is the EU's system for managing and analysing information on adverse reactions to medicines which have been authorised or are being studied in clinical trials …

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

Medicines European Medicines Agency

WEBThe European Medicines Agency (EMA) facilitates development and access to medicines for countries within the European Union (EU). EMA evaluates applications for marketing …

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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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Committee for Medicinal Products for Human Use (CHMP)

WEBThe Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines. It plays a vital role in the …

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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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Who we are European Medicines Agency

WEBOn 2 March 2020, EMA implemented changes to its organisational structure to ensure that it operates as efficiently as possible to deliver high quality outputs for public and animal …

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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 …

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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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Meeting highlights from the Committee for Medicinal Products for …

WEB10 new medicines recommended for approval. EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting.

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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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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 …

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Coronavirus disease (COVID-19) European Medicines Agency

WEBCoronavirus disease (COVID-19) is an infectious disease caused by a coronavirus.. The COVID-19 public health emergency of international concern ended in May 2023, after …

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Questions and Answers on health-based exposure limits and …

WEBQ1. Are Health-Based Exposure Limits (HBELs) required for all medicinal products? A: Yes, HBELs should be established for all medicinal products. The toxicological or …

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Direct healthcare professional communications

WEBA marketing authorisation holder may send a direct healthcare professional communication (DHPC) to healthcare professionals to inform them of important new safety information …

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Quality defects and recalls European Medicines Agency

WEBThis content applies to human and veterinary medicines. Medicinal products with a quality defect are not of the correct quality as defined by their marketing authorisation.. It is …

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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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Good pharmacovigilance practices European Medicines Agency

WEBHuman Regulatory and procedural guidance Pharmacovigilance. Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of …

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Eligible healthcare professionals' organisations European …

WEBBiomedical Alliance in Europe is a unique organisation representing leading biomedical and scientific societies in Europe.. The Association’s principal goals and objectives are to …

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Health technology assessment bodies European Medicines Agency

WEBEuropean cooperation between medicine regulators and HTA bodies will be governed by the Regulation on Health Technology Assessment (EU) 2021/2282 when it becomes …

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