European Medicines Agency - Human Medicines - Medicines for children - Priority list of off-patent medicines

Medicines for children
Paediatric-related information
Priority list of off-patent medicines
Thanks to the Paediatric Regulation, funding of studies into off-patent medicinal products (i.e. those not covered by a patent or supplementary protection certificate) is available. This funding, provided through the EU Framework Programmes, should cover the development of off-patent medicinal products with a view to the submission of an application for a paediatric-use marketing authorisation.

In order to ensure that funds are directed into research of medicinal products with the highest need in the paediatric population, the PDCO adopted the following priority list of off-patent products for which studies are required as a basis for the 5th call of the FP7 programme in 2010:

•Priority list for studies into off-patent paediatric medicinal products 2010
(EMA/387600/2010)
The following priority list is the basis for the 6th call of the FP7 programme in 2011.

•Priority list for studies into off-patent paediatric medicinal products 2011
(EMA/387600/2010)
It is open for public consultation until 5 July 2010. Please send comments using this template to paediatrics@ema.europa.eu

Applicants are encouraged to submit a PIP before applying for funding, in order to receive the Paediatric Committee’s (PDCO) opinion on the development plan. Further information regarding the PIP can be obtained:

•as a first step from the website of the European Medicines Agency (EMA), see: Medicines for Children
•through a pre-submission teleconference with the EMA, see: Paediatric investigation plans - Procedural Advice - Question 24
It should be noted that the PIP is a 120-day procedure with a clock-stop phase, during which the applicant can amend the PIP according to the requests and proposals of the PDCO. Therefore an early application is advisable.

For further information on how to apply to the calls of the 7th Framework Programme for off-patent medicines developed for children, please refer to:

■FP7 Cooperation Work Programme: Health (on the Cordis website).
A workshop on the funding through FP7 of studies into off-patent medicines developed for children was hosted at the EMA on 6 June 2007. Further information can be found under 'Workshops'.

open here please:
European Medicines Agency - Human Medicines - Medicines for children - Priority list of off-patent medicines