National Regulatory Authorities in Europe

National Regulatory Agencies of European Member States
Regulatory authorities responsible for human medicines, including paediatric drug development and authorisation.

 

Paediatric medicines development and evaluation

European Medicines Agency
European body responsible for the scientific evaluation of medicines for use in the European Union. A focus on paediatric medicines development is also available.

European Commission
Official website of the European Commission, where you can find information on law and policies, funding and public contracts and many other official information about the European Union.

EudraLex
Collection of rules and regulations governing medicinal products in the European Union.

EU Clinical Trials Register
Official source of information about interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA), clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development. It is possible to perform an advanced search, by selecting paediatric clinical trials only.

Clinicaltrials.gov
Registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
International initiative to reach harmonisation for better global health worldwide, bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration.

 

Networking

European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
Network of research networks, investigators and centres with recognised expertise in performing clinical studies in children, established at European level.

Global Research in Paediatrics (GRiP)
Network of scientists aimed at stimulating and facilitating the development and safe use of medicines in children.

EnprEMA Networks
Database of all research networks and centres with recognised expertise in performing clinical studies in children, hosted by Enpr-EMA.

 

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