European pediatric regulation

Taking into account the lack of adapted children medicine in Europe, the European parliament has put in place a new regulation concerning the development of medicines for children — Regulation (EC) No 1901/2006 as amended (the 'Paediatric Regulation'). This regulation came into force in the European Union on 26 January 2007. This new regulation allows easier clinical trials and forces the pharmaceutical companies to test future medicines in such population when appropriate. http://www.emea.europa.eu/htms/human/paediatrics/introduction.htm

This regulation is aimed at the following:

• Provide incentive to companies performing clinical trials in children

• Ensure that future medicines used in children have passed clinical testing

• That they are authorized for this specific therapeutic need

• Ameliorate the development of medicines in children by increasing their development 

• Avoid unnecessary clinical trials

With this new regulation come several necessary steps to market a pediatric drug and new entities and opportunities:

PIP

PIP stands for Pediatric Investigation Plan. It is a report that should be submitted in order to ensure that a clinical trial performed in children will meet the required criteria. It contains measures proposed to demonstrate quality, safety and efficacy, aiming at guaranteeing the necessary data for those who require pediatric treatment. During the plan, the sponsor will have to show that there is a potential therapeutic benefit to children. Although this seems evident, it is contrasted by another recurrent idea which consists in not delaying the authorization of medicines for adults with pediatric clinical trials.

Pediatric Committee

The new regulation has established a new scientific committee in the EMEA, the Pediatric Committee (PDCO). It has several important responsibilities among which are the quality assessments of Pediatric Investigation Plans for individual medicinal products. It therefore produces opinions on them. The PDCO will also give an opinion on Pediatric Use Marketing Authorizations (see 1.1.2.4), or on the safety, quality and efficacy of a medicinal product intended for pediatric use.

Rewards and incentives

Funding for research into the pediatric use of off patent medicines or active substances is provided through the Community research programs. The European Medicines Agency has been developing a list of off-patent molecules that need to be adapted to suit children needs. This list is updated every year (http://www.emea.europa.eu/htms/human/paediatrics/prioritylist.htm).

PUMA

The EMEA also created the Pediatric Use Market Authorization (PUMA) which provides a European exclusivity on the data gathered to develop a pediatric formulation of an existing off patent adult drug. It is meant to stimulate the development of off patent medicines.

The EMEA is developing a European Network for Pediatric Clinical Trials in order to facilitate the conducting of trials in this population. This network will assemble existing national and European networks, investigators and centers with specific expertise in this field.