Prescrire’s response to the public consultation on EMA/CHMP/QWP/180157/2011
"Draft - Guideline on Pharmaceutical Development of Medicines for Paediatric Use":
a pragmatic overview and 20 constructive proposals

In May 2011, the European Medicines Agency (EMA) released for public consultation a draft guideline on the pharmaceutical development of medicines for paediatric use (1).

In a letter dated 29 December 2011, the Prescrire team expressed its opinion on the draft.

> Download the detailed response (pdf)

Introduction

The pharmaceutical aspects of a medicine are important to its harm-benefit balance; they include its dosage form, excipients, dose strength or concentration, and packaging.

A strong, detailed Community guideline on the pharmaceutical aspects of medicines developed for children will be a key determinant of the quality of the treatments available for young patients in the European Union.

Such a guideline will reinforce the advances expected from implementation of the European Paediatric Regulation (2).

Measures to benefit children should focus first and foremost on their real needs. The priorities for the many healthy children in the European Union are antenatal care, postnatal follow-up and primary prevention: of serious infectious diseases (through vaccination), obesity, accidents in the home, etc. (3). Measures are also required to regulate and evaluate the many off-label uses of medicines that are useful to children but not authorised for paediatric use, and to ensure that the treatments available to children are accessible, convenient and safe.

Prescrire has been analysing drug packaging since the early 1980s: our team has systematically examined the packaging of over 5000 medicinal products, many of which concern children directly or indirectly. We have published a number of annual reports of these analyses: for the French versions, select "Les Cahiers Prescrire" from the "Libre accès" dropdown menu at www.prescrire.org, then select "Le conditionnement des spécialités pharmaceutiques"; for the English versions, search on the term “packaging” at http://english.prescrire.org.

In part I of the document, Prescrire presents a pragmatic overview of the current quality of  drug packaging insofar as it affects children. The points made are illustrated with concrete examples. Many other examples can be found in Prescrire’s annual reports of its drug packaging analyses (4)

Part II presents Prescrire's proposals to help improve draft guideline EMA/CHMP/QWP/180157, focusing first and foremost on the interests of patients.

> Download the detailed response (pdf)

References:
1- European Medicines Agency "Guideline on Pharmaceutical Development of Medicines for Paediatric Use – Draft" 19 May 2011: 23 pages.
2- "Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004" Official Journal of the European Union of 27 December 2006: L378/1-L378/19.
3- Prescrire Rédaction "Règlement européen sur les médicaments pédiatriques: surveiller son application" Rev Prescrire 2007; 27 (289): 858-862.
4- See the online dossier "Prescrire Awards" for Prescrire's annual Packaging Awards and Prescrire's annual look back at drug packaging.
> Prescrire Awards

©Prescrire December 2011