REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use

Published by EU ECRIN

The latest EU regulation for clinical trials on medicinal products for human use replaces national laws and describes the rules for assessing clinical trial applications and conducting clinical trials throughout the EU

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Paediatric Regulation

Published by EU

Regulatory Affairs Early Access Support Paediatric Medicine Paediatric Regulation EMA Paediatric Regulation Official Journal

The Regulation aims to ensure that medicines for use in children are of high quality, ethically researched and authorised appropriately and improving the availability of information on the use of medicines for children. It aims to achieve this without subjecting children to unnecessary trials or delaying the authorisation of medicines for use in adults.

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REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use

Paediatric Regulation

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