EU-regulation on medicinal products for children¹

• Procedural Guidance concerning submission of information about medicinal products as requested by the Paediatric Regulation
• Advice on the submission of information about use of authorised medicinal products in children as required by Articles 45 and 46 of the Paediatric Medicines Regulation (EC) no. 1901/2006
• Presentation of documentary evidence pursuant to Article 7 of the European Paediatric Medicines Regulation (EC) no. 1901/2006, mandatory from 26 July 2008

• Article 45 and 46 Regulation (EG) No. 1901/2006 - Variations based on the assessment of paediatric clinical trials with authorised medicinal products

The new regulation is directly binding in all EU Member States and has a tremendous effect on the development and marketing authorisation for medicinal products. It has been demonstrated that more than 50% of the medicines used to treat children in Europe have not been tested in the paediatric population and are not authorised for use in children. The overall objective is to improve children’s health in Europe by increasing the research, development and authorisation of medicines for the paediatric population without delaying the authorisation of new medicinal products for adults.

In order to achieve this, applicants will be obliged to submit an agreed paediatric investigation plan (PIP) describing the development of the medicinal product for the treatment in children together with the application from 26 July 2008. Generics, medicinal products claiming well established use, homeopathic and traditional herbal medicinal products and bio-similar medicinal products are excluded from this legal requirement. The paediatric investigation plan (PIP) has to been agreed upon by the Paediatric Committee (PDCO), the scientific committee established by the European Medicines Agency (EMEA) and is integral component of the application dossier for each new medicinal product independent of the marketing authorisation procedure (centralised, national) In well defined cases a waiver or a deferral from the obligation to submit a PIP can be requested by the applicant from PDCO.

Therefore an application submitted, without a PIP, waiver or deferral agreed by the PDCO, has to be rejected by the competent authorities as being incomplete (compliance check).

As a compensation for the new requirements set out the pharmaceutical companies will receive rewards and incentives like the extension of existing or the granting of new protection periods.

According to the regulation the PDCO was established by the EMEA on 26 July 2007. The EMEA fulfils the secretariat functions for the PDCO.

Paediatric Committee (PDCO) activities of the EMA

The PDCO replaces the Paediatric Working Party (PEG), a group of experts established by the EMEA in September 2001 , which dealt with the formulation of guidance documents and recommendations in the context of the development of medicinal products for the paediatric population..

According to the 14th amendment of the Arzneimittelgesetz (AMG) a Committee for medicinal products for children and adolescents has been established in Germany. The committee will be involved in each marketing authorisation application where a treatment of the paediatric population is requested.
The constituent meeting of the committee took place on 14. December 2006.

¹ Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004