Paediatric Medicines Legislation
The European Commission adopted a proposal in September 2004 for a Regulation on medicines for paediatric use. An overview and explanation of the proposal has also been published.
The proposed Regulation aims to establish a legislative framework that will fulfil the following main objectives:
- increased availability of medicines specifically adapted and licensed for use in the paediatric population
- increased information available to the patient/carer and prescriber about the use of medicines in children, including clinical trial data
- an increase in high quality research into medicines for children
- These will be achieved through a system of requirements and incentives.
The elements of the proposed Regulation include:
- the establishment of a new body, the Paediatric Committee, sited at the European Medicines Agency (EMEA)
for new products
- a requirement for paediatric data based on a paediatric investigation plan (PIP)
- a six-month extension of the supplementary protection certificate (SPC) if information arising from a completed PIP is incorporated into the Summary of Product Characteristics (SmPC)
for orphan medicinal products
- a two-year extension of market exclusivity if information arising from a completed PIP is incorporated into the Summary of Product Characteristics
for off-patent products
- a new category of marketing authorisation called the paediatric use marketing authorisation which will be associated with a ten-year period of data and market exprotection
- a European database of paediatric clinical trials
- a requirement to submit data from paediatric clinical trials to the regulatory authorities
- Co-ordination of a European Paediatric Clinical Trials Network.
Work on the draft texts started in October 2005 in the Council Working Group. It is likely that the Regulation will be finalised in 2006.
