Medicinal products

Medicines for children


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.

Action plan for supporting development of medicines for children

In October 2018, the European Commission and EMA published a joint action plan to support the development of medicines for children in Europe.

The action plan aims to increase efficiency of paediatric regulatory processes in the current legal framework and boost availability of medicines for children. It contains actions in five key areas, including:

  • identifying paediatric medical needs;
  • strengthening cooperation between decision makers;
  • ensuring timely completion of paediatric investigation plans (PIPs);
  • improving the handling of PIP applications;
  • increasing transparency around paediatric medicines.

The action plan addresses challenges identified by the European Commission’s ten-year report on the implementation of the Paediatric Regulation. It also takes into account the ideas on How to better apply the Paediatric Regulation to boost the development of medicines for children collected during the multi-stakeholder workshop organised by EMA and the European Commission in March 2018.

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

The 2013 progress report on the Paediatric Regulation covered the initial five years of its applicationIt 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:

Related information