On 12 December 2006, EC Regulation 1901//2006 on medicinal products for paediatric use (the “Regulation”) was adopted. The Regulation came into force on 26 January 2007.
It is the objective of the Regulation is to establish a legislative framework that encourages the increased research and development of medicines for the treatment of children, greater availability of medicines specifically licensed for use in children and improved quality and availability of information regarding the use of medicines in children, including clinical trials data. These goals are intended to be achieved without subjecting children to unnecessary clinical trials or delaying the regulatory approval of medicines for use in adults.
The key aspects of the Regulation are:
(i) amended requirements for marketing authorisation application for new products to include paediatric data as required by a previously agreed Paediatric Investigation Plan (“PIP”);
(ii) a 6 month extension of the Supplementary Protection Certificate if information arising from the completed PIP is incorporated into the Summary of Product Characteristics;
(iii)for orphan medicinal products, an additional 2 years of market exclusivity to the existing 10 years awarded under the EU Orphan Drug Regulations if information arising from the completed PIP is incorporated into the Summary of Product Characteristics;
(iv)the establishment of a new kind of marketing authorisation, the Paediatric Use Marketing Authorisation (“PUMA”) allowing 10 years of data exclusivity to stimulate the development of offpatent products for use in the paediatric population; and
(v) the establishment of a new body, the Paediatric Committee, sited at the European Medicines Agency.