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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 …

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 …

Category:  Medicine Go Health

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 …

Category:  Health Go Health

European medicines regulatory network

WebThe European medicines regulatory network is the cornerstone of EMA's work and success.The Agency operates at the heart of the network, coordinating and supporting …

Category:  Medicine Go Health

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 …

Category:  Medicine Go Health

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 …

Category:  Medicine Go Health

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 …

Category:  Health Go Health

ICH E6 (R3) Guideline on good clinical practice (GCP)

Web1 I. INTRODUCTION. Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the. conduct of trials that involve human participants. Clinical trials …

Category:  Health Go Health

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 …

Category:  Health Go Health

Committees, working parties and other groups

WebEMA maintains a public list of European experts who carry out the scientific work of the Agency. This includes serving as members of the Agency's scientific committees, …

Category:  Health Go Health

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 …

Category:  Medicine Go Health

Mounjaro European Medicines Agency

WebMounjaro is a medicine used together with diet and physical activity to treat adults who have type 2 diabetes which is not satisfactorily controlled. It can be used on …

Category:  Medicine Go Health

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 …

Category:  Medical Go Health

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 …

Category:  Medicine Go Health

Q 1 A (R2) Stability Testing of new Drug Substances and …

Web1.1. Objectives of the Guideline. The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug …

Category:  Health Go Health

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, …

Category:  Medicine Go Health

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 …

Category:  Coronavirus Go Health

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 …

Category:  Medicine Go Health

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 …

Category:  Health Go Health

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