The European Medicines Agency has a number of important tasks and responsbilities relating to the development of paediatric medicines. These were brought in by the Paediatric Regulation in January 2007.
This legislation concerns the development and authorisation of medicines for use in children aged up to 17 years and introduced sweeping changes into the regulatory environment for paediatric medicines, designed to better protect the health of children in the European Union (EU). The main change introduced was the creation and operation of the Paediatric Committee within the Agency to provide objective scientific opinions on development plans for medicines for use in children.
This section of the website provides information for companies or individuals wishing to develop a paediatric medicine and requiring guidance for the approval of a paediatric investigation plan (PIP), together with other information relating to paediatric medicines.
- Paediatric Regulation
- Application guidance
- Opinions and decisions on paediatric-investigation-plan applications
- Post-assessment guidance
- Supporting information
- Paediatrics: Regulatory and procedural guidance
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- Opinions and decisions on paediatric investigation plans
- Paediatric Committee
- European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
- Medicines for children: Background information
- Better medicines for children (18/05/2015)
All Microsoft Office documents submitted to the European Medicines Agency must be in a format compatible with MS Office 2003. Office 2007 and Office 2010 formats cannot currently be accepted. PDF certified electronic application forms require Adobe Reader 10.0 or higher. Please visit eSignature for more information on digitally signed electronic documents.