Medicinal products for human use

Medicines for children

 
 

Doctor examining a child © Dmitry Naumov - Fotolia.com

The Paediatric Regulation has governed the development and authorisation of medicines for paediatric use since entering into force in 2007. Its objective is to improve the health of children in Europe by addressing the low level of research and development into medicines for children by pharmaceutical companies.

The Regulation is structured around three main objectives:

  • More medicines for children
  • Better product information
  • More paediatric research

The Regulation sets up a system of obligations, rewards and incentives to encourage manufacturers to research and develop medicines for children’s specific therapeutic needs. It obliges companies to screen every new product they develop for its potential use in children, to progressively increase the number of products with paediatric indications. This is done at the earliest stage of development through the 'Paediatric Investigation Plan’ (PIP) which is an obligatory part of overall product development. That plan needs to be agreed with the European Medicines Agency, which is supported by its Paediatric Committee.

In addition, the Regulation promotes high-quality information and high-quality research into medicines for children through measures, such as:

  • An EU network of networks of investigators and trial centres carrying out paediatric research;
  • An EU inventory of paediatric needs;
  • A public database of paediatric studies; and
  • A requirement for companies to submit any existing paediatric studies on authorised medicinal products for scrutiny by regulatory authorities.

The 2017 Paediatric Report

In October 2017 the Commission presented to the European Parliament and the Council a comprehensive report on progress made in children's medicines 10 years after the Paediatric Regulation came into force:

The report is complemented by the following documents:

The 2017 Commission report builds moreover on the results of a public consultation.

Previous reports

2013 progress report on the Paediatric Regulation covering the five years of its application. This report is based on a public consultation document. A summary of the replies is available here. The Consultation built on the "Five-year Report to the European Commission" drafted by the European Medicines Agency with its Paediatric Committee.

Additionally, the Commission publishes on an annual basis a report on companies and products that have benefited from any of the rewards and incentives of the Regulation and companies that have failed to comply with obligations of the Regulation:

Additional information: