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- Paediatric Regulation
The Paediatric Regulation came into force in the European Union (EU) on 26 January 2007. Its objective is to improve the health of children in Europe by:
- facilitating the development and availability of medicines for children aged 0 to 17 years;
- ensuring that medicines for use in children are of high quality, ethically researched and authorised appropriately;
- improving the availability of information on the use of medicines for children.
It aims to achieve this without:
- subjecting children to unnecessary trials;
- delaying the authorisation of medicines for use in adults.
The Paediatric Regulation dramatically changed the regulatory environment for paediatric medicines in Europe.
Legislation
The Paediatric Regulation is comprised of:
- Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use;
- Regulation (EC) No 1902/2006, an amending regulation in which changes to the original text were introduced relating to decision procedures for the European Commission.
For more information, see:
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Joint European Commission/European Medicines Agency document: Priorities for implementation of the regulation on medicinal products for paediatric use | (English only) | 01/09/2006 | |||
| The European paediatric initiative: History of the paediatric regulation | (English only) | 11/07/2007 | |||
| Presentation - The Paediatric Regulation | (English only) | 01/01/2007 | |||
| Report on the experts round table on the difficulties related to the use of new medicinal products in children held 18 December 1997 | (English only) | 30/07/1998 | 11/02/2010 | ||
| Recommendation of the Paediatric Committee to the European Commission regarding the symbol | (English only) | 01/12/2007 |