martes, 31 de marzo de 2009


Medicines for children
The EU Paediatric Regulation
A new Paediatric Regulation entered into force in the European Union (EU) on 26 January 2007.

The objective of the Paediatric Regulation 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,

subjecting children to unnecessary trials,
or delaying the authorisation of medicines for use in adults.
The Paediatric Regulation dramatically changes the regulatory environment for paediatric medicines in Europe. The leaflet on the right provides a brief overview of the key aspects of the changes in which the European Medicines Agency has a role to play.

The legislation in full, plus related documents

The new legislation comprises:
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.

Frequently asked questions on regulatory aspects of Regulation (EC) No 1901/2006 (Paediatric Regulation) amended by Regulation (EC) No 1902/2006 (EMEA/520085/2006).
Joint European Commission/EMEA implementation plan for the Paediatric Regulation.
'Medicines for children' section of the DG Enterprise and Industry (European Commission) website.
The European paediatric initiative: History of the Paediatric Regulation (EMEA/17967/04)
EMEA/27164/98 Report on the Experts Round Table on the Diffficulties related to the Use of New Medicinal Products in Children (held 18 December 1997) (Rev. 1)

European Commission statement as of 30 January 2008 on the selection of a symbol according to Article 32 of the Paediatric Regulation for medicinal products with a paediatric indication. The Recommendation of the Paediatric Committee of the European Commission regarding the symbol can be found here.
Leaflet providing an overview of the EMEA's role in the European regulatory environment for paediatric medicines.

Click the image to download a PDF version of the leaflet. [aquí he cometido un error técnico al incorporar el acceso, trataré de resolverlo a la brevedad, gracias]

abrir aquí para acceder al documento que modifica secuencialmente el marco regulatorio europeo:
European Medicines Agency - Human Medicines - Regulatory and procedural guidelines - Paediatrics

ingresar a través del acceso que se describe al pié, a efectos de poder acceder al leaflet:

No hay comentarios:

Publicar un comentario