Writing in Pharma Times Peter Mansell reports that, in its first year of operation, the European Medicines Agency’s Paediatric Committee (PDCO) received 233 applications (covering 420 indications), adopting 70 positive opinions on paediatric investigation plans (PIPs) and waivers from these requirements, but only one negative one. 61% of these decisions were for as-yet unlicensed products.Under Regulation 1901/2006 companies seeking approval for a new medicinal product, a new indication, route of administration or pharmaceutical form of an existing patent-protected drug must submit a PIP which spells out how they they propose to develop the drug for the various subsets of the paediatric population. If the proposal is approved, the drug's supplementary protection certificate will secure a six-month extension.
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