Abstract
A large proportion of medicines used in children are prescribed off-label, and children have often been denied access to new or innovative medications. Because such situation is unethical, the need to obtain paediatric information for medicines used in children seems nowadays a matter of consensus on a global basis. Based on this, it was clear in EU, like what has happened in the US, that there was a need for a legal obligation for Pharmaceutical Companies to perform studies. This new European Paediatric Regulation that entered into force in 2007 opens a new era of European drug regulatory history and will offer a major opportunity to improve children's health through advancements in research by providing a new framework for evaluating the efficacy and safety of medicines for children. But, paediatric development remains challenging and the hurdles of conducting research in paediatric population are numerous. The article presents the new European Paediatric Regulation, illustrates its rationale through paediatric psychopharmacology, and discusses some of its consequences on paediatric research from an industry perspective. Recommendations for further international collaboration are also suggested to make global paediatric development plans.
Highlights
A large proportion of medicines used in children are prescribed outside the terms of the drug license i.e. off-label, which can place children at a direct risk of under- or overdosing and a delayed risk of long-term adverse effects
If the Pharmaceutical Companies submitted studies responding to the Paediatric Written Request (PWR), six additional months of marketing exclusivity were received
The timelines of obligation for Pharmaceutical Companies are that: 18 months from entry into force (July 2008), applications for new marketing authorisation applications should contain results of studies conducted in compliance with agreed Paediatric Investigation Plan (PIP) unless waiver or deferral; 24 months from entry into force (January 2009), application for new indications, new routes of administration or new pharmaceutical forms should contain results of studies in compliance with agreed PIP unless waiver or deferral
Summary
A large proportion of medicines used in children are prescribed outside the terms of the drug license i.e. off-label, which can place children at a direct risk of under- or overdosing and a delayed risk of long-term adverse effects. The first critical paediatric legislative initiative in the US is the Food and Drug Administration Modernization Act that in 1997 provided an incentive for Pharmaceutical Companies to study products for which there would be a health benefit in the paediatric population. The timelines of obligation for Pharmaceutical Companies are that: 18 months from entry into force (July 2008), applications for new marketing authorisation applications (new products) should contain results of studies conducted in compliance with agreed Paediatric Investigation Plan (PIP) unless waiver or deferral; 24 months from entry into force (January 2009), application for new indications, new routes of administration or new pharmaceutical forms should contain results of studies in compliance with agreed PIP unless waiver or deferral The aim of this new regulation is to improve the health of the children of Europe, by:. - Paediatric data is mandatory for all regulatory submissions for new products and for products still on patent in case of line extension (unless waivers or deferrals) according to a PIP agreed upon by the PDCO
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