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Public Health

2017 Commission Report on the Paediatric Regulation



The 2006 Paediatric Regulation aims to address a gap in knowledge on how medicine should best be used by children. At the time of adoption of the Regulation, many products administered to children were still prescribed by doctors based on experience (off-label) rather than on the results of targeted paediatric clinical research. The Regulation intends to reduce the level of off-label use and increase the number of medicines specifically developed and tested for children.

In 2013, the Commission published a first report on the Paediatric Regulation and while it revealed some promising signs of progress, it found that, due to the length of medicinal products' development, it would take at least 10 years to gain a full understanding of the situation.

Under Article 50(3) of the Regulation, the Commission’s second report was released in 2017. It assessed the Regulation's impact on public health and businesses and was presented to the European Parliament and the Council, as the two legislative bodies that adopted the Paediatric Regulation in 2006. It is aimed at informing EU decision-makers about the experience with the Regulation.

Targeted stakeholder consultation on the experience acquired with the Paediatric Regulation

Period of consultation

From 15 November 2016 to 20 February 2017.

Contributions to and results of the consultation

A summary of the responses is available here.

Below are the public responses to the above-mentioned public consultation:




Patient groups

Healthcare professionals


Public authorities


Targeted stakeholders

All stakeholders involved in the development, manufacture and/or commercialisation of paediatric medicines, as well as paediatric patient/parent groups, healthcare professionals and academia.

Objective of the consultation

The purpose of this consultation paper is to support the Commission in drafting its second report and to gather stakeholder views and feedback.

The consultation document

The consultation document can be downloaded here.

Reference documents

Before answering to the public consultation, we invite you to take a look at the following background documents:

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.

Specific privacy statement

Contributions will be published on the Internet. It is important to read the specific privacy statement attached to this consultation for information on how your personal data and contribution will be dealt with.

Additional information: