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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Clinical Trials Toolkit
Paediatric Regulation
Published by EU
Regulatory AffairsEarly Access SupportPaediatric MedicinePaediatric RegulationEMA Paediatric RegulationOfficial JournalThe 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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