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>70. 300. ˜100. >2 000. >380 000. Paediatric regulation. 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

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>70

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  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 Regulation3 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 subsetsapplicable to • Pharmaceutical development (paediatric forms) • Pre-clinical studies (such as juvenile toxicity) • Clinical studies in children Subsets of population to be considered (neonates, infants, children, adolescents)

  7. EU Paediatric RegulationKey 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. PDCO COMPOSITION: 5 CHMP members + 1 members per Member State not yet represented + 6 members from families & HCP associations Each member has an alternate

  11. Early

  12. 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: 596 including full waivers for the paediatric development for the whole indication 58 * ‘Application’ covers one or more indication(s)

  13. Facilitate Research

  14. Rapporteur

  15. Peer Reviewer

  16. www.emea.europa.eu

  17. Thank you

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