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Fostering the development of medicines suitable for children is a joint effort

Fostering the development of medicines suitable for children is a joint effort

25.9.2018

More than a decade has already passed from the entry into force of the EU’s Paediatric Regulation in 2007, and during this time, more than 200 medicinal products shown to be suitable for children have been placed on the market. This amount accounts for nearly 25% of all new medicines authorised for marketing in the EU over this time period.

EMA’s Paediatric Committee fosters medicines for children

Following the entry into force of the Paediatric Regulation, the European Medicines Agency’s (EMA) Paediatric Committee (PDCO) has established its operations. PDCO reviews all the paediatric investigation plans (PIPs) that are required to be agreed prior to marketing authorisation applications.

Since its establishment, the Paediatric Committee was tasked with supporting the development and investigation of medicines for children in the EU and to safeguard the availability of medicines that are suitable for children, properly studied and as safe as possible. The objective was to make the development of medicines suitable for the treatment of children an integral part of medicine development programmes.

- The Paediatric Regulation has had a clearly positive effect on the number of medicines suitable for children and the amount of information available on medicines, and paediatric medicines are finally becoming a well-established part of pharmaceutical development, says Ann Marie Kaukonen, Senior Researcher at Fimea and a member of the Paediatric Committee.

- New therapies for children and new therapeutic indications for younger age groups have become available to treat rheumatic diseases, for example. Furthermore, a number of products for the treatment of viral, bacterial and fungal infections or for lowering blood pressure and cholesterol have been made available in formulations that have been demonstrated to be suitable for children. Additionally, for paediatric cancers, the first product for the treatment of neuroblastoma has become available.

EMA also coordinates the European Network of Paediatric Research (Enpr-EMA) that focuses on facilitating clinical trials on paediatric medicines. According to the EudraCT database, the proportion of paediatric clinical trials of all clinical trials has been on the rise (12.4% in 2016).

Paediatric medicines was a strategic priority area at the National Agency for Medicines

Fimea and its predecessor, the National Agency for Medicines, have been actively involved in the implementation of the Paediatric Regulation and in the assessment of medicines suitable for children. Prior to the entry into force of the Paediatric Regulation (between 2003 and 2007), experts from the National Agency for Medicines participated in the work of the Paediatric Working Party (PEG) of the Committee for Medicinal Products for Human Use (CHMP).

The members of the PEG were actively involved in the preparation of the Paediatric Regulation in the EU and supported the national authorities in the preparation stage of the regulation. An important task of the PEG was to identify medicinal substances from different therapeutic areas on the efficacy and safety of which more research evidence was need before they could be adopted for paediatric use. The PEG also gave scientific advice and prepared guidelines for the developers of paediatric medicines. Following the entry into force of the Paediatric Regulation, the tasks of the PEG were assigned to the Paediatric Committee.

To celebrate the anniversary, the European Medicines Agency EMA has published an information package of the subject on its website. In October 2017, the European Commission published a ten-year report on implementation of the Paediatric Regulation and on the progress made to date.

Fimea participated in the training event targeted at healthcare professionals, the National Conference on Paediatric Medicines, that was held on 20–21 September 2018 in Helsinki.

Read more:

About paediatric medicines on the EMA website:
Fostering medicines for children, EMA’s news article 28 August 2018

Factsheet: Supporting medicines for children in the EU

Paediatric medicines, overview

On the Commission website:
Medicines for Children

About paediatric medicines on the Fimea website:

Pharmaceutical safety and information/Regulation on Medicinal Products for Paediatric Use

Marketing Authorisations/Paediatric medicines

For public/
Medicines for children

Developing better medicines for children
 

 

Ask more

  • Ann Marie Kaukonen, Senior Researcher, tel. +358 29 522 3351
  • Pia Annunen, Senior Medical Officer, tel. +358 29 522 3460
  • Merete Broms, Coordinator for Paediatric Medicines, tel. +358 29 522 3319
  • Email address format: firstname.lastname@fimea.fi
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