By way of derogation from paragraph 1, the Agency shall make public part of the information on paediatric clinical trials entered in the European database in accordance with the provisions of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use

The main provisions of the Paediatric Regulation [(EC) 1901/2006] were applicable from 26 July 2008, to meet three main objectives: 1) to ensure high-quality research into the development of medicines for children; 2) to ensure, over time, that the majority of medicines used by children are specifically authorised for such use with appropriate forms and formulations; and 3) to ensure the availability of high-quality information about medicines used by children.

Whilst the report shows considerable improvements in the developments of medicines for children the Commission will continue to monitor the implementation of the Paediatric Regulation, thereby also addressing some weaknesses or deficits that have been identified so far.

a commitment to EU funding into studies on off-patent medicines for children (the so-called “M.I.C.E. Programme”); the establishment of an expert committee, the Paediatric Committee within the European Medicines Agency (EMEA); measures to increase the robustness of pharmacovigilance for medicines for children; an EU inventory of the therapeutic needs of children to focus research, development and authorisation of medicines; an EU network of investigators and trial centres to conduct the research and development required; a system of free scientific advice for the industry, provided by the EMEA; a publicly available database of ...[+++] paediatric studies.

a commitment to EU funding into studies on off-patent medicines for children (the so-called “M.I.C.E. Programme”); the establishment of an expert committee, the Paediatric Committee within the European Medicines Agency (EMEA); measures to increase the robustness of pharmacovigilance for medicines for children; an EU inventory of the therapeutic needs of children to focus research, development and authorisation of medicines; an EU network of investigators and trial centres to conduct the research and development required; a system of free scientific advice for the industry, provided by the EMEA; a publicly available database of ...[+++] paediatric studies.

a new expert committee, within the European Medicines Agency to assess and agree companies’ testing plans; a requirement at the time of marketing authorisation applications for data on the use of the medicine in children (plus a system of waivers from this requirement for medicines unlikely to benefit children and a system of deferrals to ensure medicines are tested in children only when it is safe to do so and to ensure the requirements do not delay the authorisation of medicines for adults); a reward for studying medicines for children of 6-months extension to the supplementary protection certificate - in effect, six-month patent e ...[+++]xtension; for off-patent medicines, ten-years of data protection for new studies awarded via a Paediatric Use Marketing Authorisation (P.U.M.A); increased safety monitoring for children’s medicines and compulsory submission by industry of existing studies in children; an EU inventory of the therapeutic needs of children and an EU network of investigators and trial centres to conduct the studies required; a system of free scientific advice for the industry, provided by the European Medicines Agency.