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null 10-year report by the European Commission on the impact of the Paediatric Regulation published

10-year report by the European Commission on the impact of the Paediatric Regulation published

13.11.2017

The European Commission has published a ten-year report on the impact of the Paediatric Regulation.

The Regulation on Medicinal Products for Paediatric Use entered into force in 2007. The objective of the Regulation was to improve the health and medicinal treatment of children and to increase the amount of medicines studied and suitable for children. Additionally, the purpose of the Regulation was to increase the availability of high-quality information about the correct use of, and to promote high-quality research into paediatric medicines.

Paediatric medicine development has become a part of the overall development of medicines

The report notes that the Paediatric Regulation has had a clear positive effect. Following the Regulation, paediatric medicine development has become an integral part of the overall development of medicines.

Between 2007 and 2016, over 260 new medicines for use by children were authorised, either as entirely new marketing authorisations or as new therapeutic indications. The effects of the Regulation are best seen in therapeutic areas where medicines are also developed for adults. New medicines for children have been authorised in rheumatology, infectious and heart diseases in particular, as well as in vaccines.  The effects of the Regulation are weaker in diseases that only affect children or where the course of the disease differs between adults and children. The increase in the development of paediatric medicines is also apparent in that children more often participate in clinical trials . In Europe, the proportion of clinical trials with children has increased to 12.4 % of all trials in 2016 compared to 8.25 % in 2007.

The report concludes that the system of obligations and rewards used in the Regulation mainly works as intended. However, the Paediatric Use Marketing Authorisations (PUMA) concept, a system of rewards for off-patent medicines to incentivise the development of paediatric medicines, has so far failed to yield the desired result.

Before proposing any amendments to the Paediatric Regulation, the Commission intends to carry out an overall evaluation of the functioning and combined effects of regulations that regulate the development of paediatric and orphan medicines. Additionally, the European Commission and the Paediatric Committee intend to foster the implementation of and guidance on the Regulation and the international cooperation between the various parties involved.

Read more:

State of Paediatric Medicines in the EU - Report from the Commission to the European Parliament and the Council

Press release of the European Commission

Questions and Answers on the Paediatric Regulation

10-Year report by the European Medicines Agency and its Paediatric Committee

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  • Ann Marie Kaukonen, Senior Researcher, tel. +358 29 522 3351
  • The e-mail addresses have the form firstname.lastname@fimea.fi