EMEA and EU Commission – Topical News Paediatric Regulation: Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies, COM 2008/C 243/011). RAin Dr. Brigitte Friese In the course of implementation of the provisions introduced by the Paediatric Regulation a number of guidelines has to be elaborated by the Commission in cooperation with the competent authorities of the Member States, the EMEA and interested parties to ensure the functioning of the system. On 24 September 2008 the Commission published a “Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies”. The guideline consists of 3 sections: Section 1 contains explanations regarding the completion of the application format. The application format itself will consist of 6 Parts and will be applicable to all kinds of applications in relation to the paediatric investigation plan. Section 2 of the guideline covers guidance on the operation of the check performed by the competent authorities, whether applications for marketing authorisations as well as the studies submitted comply with the provisions of the Paediatric Regulation, respectively, the agreed paediatric investigation plan. Finally, Section 3 offers guidance on the assessment criteria in relation to the classification of studies as ‘significant’, if they started before and were completed after 26 January 2007. |
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pharmind 2008, Nr. 12, Seite 1464
