Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

PDCO – one year experience of the paediatric regulation

Dr. Detelina Ivanova (Abschlußjahr: 2009)

Language: English

For already around 2 years we have the chance to observe the impact of the efforts for improving the research and development of the pharmaceutical products for the paediatric population. Thus, on 26th January 2007 the Paediatric Regulation came into force. Subsequently, in June 2007 the Paediatric Committee was set up and since its establishment it contributes enormously to the achievement of the above mentioned goal, especially with regard to the development, authorisation procedure and use of medicinal products in children.
The aim of this Master Thesis is to elaborate upon the reasons behind the PDCOs foundation, analyse the conditions which led to the introduction of the Paediatric Regulation, as well as to reflect upon the activities of the PCDO during its first year.

It is well known that most of the medicinal products used in the paediatric population are not studied in this population but generally mainly in adults. Furthermore, the off-label use of medicinal products used in some subset groups is also wide spread. The consequences of these improper applications are also observed and may vary from ineffective treatment to serious adverse reactions. Therefore, in order to handle these critical issues, the Paediatric Regulation 1901/2006 was introduced in the EU in 2007. The main purpose of this regulation is to promote the development of medicinal products for paediatric use so that the use of off-label and unauthorized medicinal products is no longer required. In addition to this, prospective monitoring of ADR s in children is also supported, in order to obtain an objective picture of the risks and benefits of the paediatric medicines.

The newest created committee in the EMEA the PDCO also has the goal to support this improvement process of the medicinal products for children. To achieve this, the PDCO gives its expert opinion on different issues concerning the development of medicinal products for their use in the paediatric population. By assessing either the content of a PIP for each medicinal product submitted to it or their waivers and deferrals, it is capable of providing a competent opinion to these subjects. Moreover, the compliance of the application for a Marketing Authorisation with the agreed PIP concerned at the request of CHMP, a competent authority or the applicant as well as any generated data concerning the quality, safety or efficacy of a medicinal product should be evaluated by PDCO as well. Another important activity of the PDCO is its participation in the preparation of the guidelines. These guidelines should provide recommendations and directions on the research and development processes of the medicinal products for paediatric population. Additionally, the PDCO gives advices to the companies throughout the whole process so that they could implement these directions. The PDCO is responsible for supporting the EMEA and the Commission concerning the communication requested during carrying out of a research into medicinal products for use in the paediatric population.

To ensure the right cooperation and coordination of its activities, the PDCO holds 3-days meetings on a monthly basis. During its first year the PDCO discussed and provided its opinion on 233 applications, approximately 420 indications.

Pages: 45