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PAEDIATRIC REGULATION

PAEDIATRIC REGULATION. PaEDIATRIC REGULATION EC 1901/2006. November the 14th. WINTERGERST Delphine. Summary. Introduction The European Paediatric Regulation Paediatric Committee Paediatric Investigation Plan Marketing authorisation R ewards, incentives and penalties Conclusion.

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PAEDIATRIC REGULATION

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  1. PAEDIATRIC REGULATION PaEDIATRIC REGULATION EC 1901/2006 November the 14th WINTERGERST Delphine

  2. Summary • Introduction • The European Paediatric Regulation • Paediatric Committee • Paediatric Investigation Plan • Marketing authorisation • Rewards, incentives and penalties • Conclusion

  3. Introduction • Paediatric population : “part of the population aged between birth and 18 years” • Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006. Title 1, Chapter 1, Article 2. • 20% of the European population are children ⇒ 100 millions of people Source: Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006.European Commission. Progress report on the paediatric regulation EC n°1901/2006. 2013.

  4. The European Paediatric Regulation • Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006 Source: Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006.

  5. Structure of regulation (EC) no 1901/2006 Title I: Introductory provisions Title II: Marketing authorisation requirements Title III: Marketing authorisation procedures Title IV: Post-authorisation requirements Title V: Rewards and incentives Title VI: Communication and coordination Title VII: General and final provisions Source: Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006.

  6. Paediatric Committee • By 26 July 2007 ⇒ Creation of a Paediatric Committee within the European Medicines Agency • ➡ Assessment and advice about medicinal products for paediatric use • Composition of the Paediatric Committee:Article 4 • Organisation of the Paediatric Committee: Article 5 • Tasks of the Paediatric Committee:Article 6 • Creation of a symbol (Article 6 & 32) • Collect available data on all existing uses of medicinal products in the paediatric population (Article 6 & 42) • Establish the inventory of therapeutic needs (Article 6 & 43) • Develop a European network of existing national and European networks, investigators and centres with specific expertise in the performance of studies in the paediatric population (Article 6 & 44) Source: Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006.

  7. Paediatric Investigation Plan (PIP) • « a research and development programme aimed at ensuring that the necessary data are generated determining the conditions in which a medicinal product may be authorised to treat the paediatric population » Article 2 • Products which don’t need any PIP: • Ineffective or unsafe drugs • Drugs occurs only in adult population • Not a significant therapeutic benefit over existing treatment. Article 11 • ➡ Justification needed • Specification of the timing and the measures proposed to assess the quality, safety and efficacyof the medicinal product in paediatric population for : • Products which apply for a marketing authorisation. Article 7 • Products which apply for a supplementary protection certificate. Article 8 • Paediatric Products which apply for a marketing authorisation. Article 30 Source : European Commission. Progress report on the paediatric regulation EC n°1901/2006. 2013 Source: Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006.

  8. Time table for PIP 10 days Final decision by the Agency Source: Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006.

  9. Marketing authorisation • After the marketing authorisation and thanks to the PIP: • Applications for a marketing authorisation that includes a paediatric indication • Applications to include a paediatric indication in an existing marketing authorisation • Applications for a paediatric use marketing authorisation • Article 34 Source: Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006.

  10. Rewards, incentives and penalties • Rewards • Six-month extension on the supplementary protection certificate granted only if the product is authorised in all Member States OR • One-year extension of the period of marketing protection for the medicinal product concerned • Article 36 • Concerning the orphan medicinal products, the ten-year period of protection granted in the marketing authorisation is extended to twelve years. • Article 37 • Funds for research into medicinal products for the paediatric population is provided for in the Committee budget • Article 40 Penalties Each Member State determine the penalties to be applied for infringement of the provisions of this Regulation ➡ Penalties effective, proportionate and dissuasive. Article 48 Source: Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006.

  11. To Conclude Creation of a regulation for medicinal products for paediatric population ➡ Regulation (EC) no 1901/2006 Improve research and number of medicinal products for paediatric population Facilitate medicinal products for paediatric population development Ensure Safety, Efficacy and Quality of products for paediatric population Source : European Commission. Progress report on the paediatric regulation EC n°1901/2006. 2013

  12. Thank you Any question ?

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