Development of Paediatric Medicinal Products from a Regulatory Point of View – our tutorial at the DIA EuroMeeting in Copenhagen

On March 26, 2012 at the DIA EuroMeeting in Copenhagen, Dr. Dobmeyer explains what must be taken into account in the development of paediatric medicinal products from a regulatory point of view – a subject which the European Medicines Agency, EMA, has also included in its road map for 2015. In the EMA's view, there are still insufficient treatment possibilities in this area, or none at all.

The Paediatric Investigation Plan (PIP)
The paediatric investigation plan or the application for a waiver or deferral are decisive factors for the successful development of medicinal products. According to Articles 7 and 8 of the Regulation (EC) No. 1901/2006 on medicinal products for paediatric use, pharmaceutical companies must submit either an investigation plan or a decision on waiver of deferral by the Paediatric Committee (PDCO) of the EMA with the marketing authorisation documents. These rules apply both for medicinal products which are to be newly authorised in the EU (Art. 7) and for the submission of an application for authorisation of new indications, new pharmaceutical forms and new routes of administration for certain already authorised medicinal products (Art. 8).

Early planning – the way to successful authorisation
The PIP contains a research and development programme with regard to attaining a paediatric indication of the medicinal product in question. In order to ensure the trouble-free development of the medicinal product, the creation of a PIP or the application for waiver or deferral should therefore be scheduled at an early stage.