Transcript Document
1 >70 300 ˜100 2 >2 000 >380 000 3 Paediatric regulation 4 Key objectives of the new EU Paediatric Regulation – To improve the health of the children of Europe by: • increasing high quality research for medicinal products for children • promoting the development and authorisation of such medicines at the EU level • improving the information on medicines designed for children – While avoiding unnecessary studies in children and not delaying the authorisation of medicines for adults 5 EU Paediatric Regulation 3 Pilars • Paediatric Investigation Plan (PIP) • Reward (incentives) for studies conducted • Paediatric Committee (PDCO) at the EMEA 6 PIP Includes timing of planned studies for all the paediatric population subsets applicable to 1. Pharmaceutical development (paediatric forms) 2. Pre-clinical studies (such as juvenile toxicity) 3. Clinical studies in children Subsets of population to be considered (neonates, infants, children, adolescents) 7 EU Paediatric Regulation Key elements • Mandatory paediatric development for new products according to a PIP agreed upon by the PDCO (possible deferrals or waivers) • Mandatory submission of paediatric data when filing new applications unless waiver or deferral approved by the PDCO • New Marketing Authorisation Procedure for off-patent products (PUMA) 8 Incentives Incentives for new medicinal products and line extensions of patented medicinal products: Reward for studies conducted: 6-month extension of the patent or the supplementary protection certificate (SPC) Covers new indications, new pharmaceutical forms and new route of administration For orphan medicines, 2-year additional market exclusivity (10+2) 9 Incentives Incentives for off-patent medicines specifically developed for children New type of Marketing Authorisation (PUMA) Paediatric Use Marketing Authorisation • Covers only the paediatric indication(s) and formulation(s) • Enabling 10-year (8+2) data protection 10 11 PDCO COMPOSITION: 5 CHMP members + 1 members per Member State not yet represented + 6 members from families & HCP associations Each member has an alternate 12 Early 13 PIP applications EMEA received after 12 months of activities (by submission deadline 20.12.2008) PIP applications* 356 corresponding to Number of indications covered in the requests for PIPs or waivers: including full waivers for the paediatric development for the whole indication 596 58 * ‘Application’ covers one or more indication(s) 14 Applications by therapeutic area Oncology Endocrinology, gynecology, metabolism Cardiovascular Neurology 3% 2% Pain 5% 19% Immunology 8% Haematology 5% Vaccines Other 6% 17% Infectious diseases 5% Pneumology/Allergy 5% 3% 2% 2% 5% 13% Uro/Nephrology Psychiatry Ophtalmology Diagnosis Facilitate Research 15 Rapporteur 16 Peer Reviewer 17 www.emea.europa.eu 18 Thank you 19