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Pediatric drugs, the EU regulation

The final agreement on the regulation on medicines for pediatric use has finally been reached by the European Union, Commission and Council and will be formalized in the coming days. Currently, more than 50% of medicines used by children have not been tested and authorized for this specific use. Following a proposal presented by the European Commission in September 2004 - explains a note - the regulation agreed today will improve the health of children on the Old Continent by increasing the availability of fully tested, authorized medicines specifically intended for pediatric use. Thanks to a series of prescriptions, prizes and support measures, the regulation will boost high-level activities in the field of research, development and authorization of medicines for pediatric use. The measures of crucial importance are

1. Requirements: when applying for marketing authorization for a medicinal product for pediatric use, data on the use of that medicinal product in children should be provided from an agreed pediatric investigation programme; a system of waivers for prescriptions for medicines unlikely to benefit children; a system of postponement of the time limits established by the prescriptions aimed at ensuring that the trials of medicines on children only take place when it can be carried out safely, while at the same time preventing the authorization of medicines for use in adult patients from being delayed by the prescriptions themselves.

2. Awards: an incentive to comply, in the form of a six-monthly extension of the Supplementary Certificate of Protection (for all practical purposes equivalent to a six-monthly patent extension); for orphan medicinal products, an incentive to comply with prescriptions in the form of two additional years of market exclusivity, to be added to the ten granted under the EU regulation on orphan medicinal products; a new type of marketing authorisation, the Pediatric Use Marketing Authorization (Aicup), which grants ten-year protection to innovation data (new studies) concerning products whose patent has expired.

3. Support measures: an EU commitment to finance studies on medicines for children whose patent has expired (the so-called Mice programme); the establishment of a committee of experts, the Pediatric Committee, within the European Medicines Evaluation Agency (EMEA); measures aimed at strengthening the pharmacovigilance of medicines for pediatric use; a European inventory of therapeutic needs of children, intended to correctly focus the research, development and authorization of related medicines; a European network of researchers and testing centers to carry out the necessary research and development activities; a free scientific advice system for operators in the sector, provided by the EMEA; a publicly accessible database on pediatric studies. The second reading of the European Parliament tightened up certain provisions of the regulation, relating inter alia to the safety of medicinal products, transparency and the conditions to which the granting of prizes is subject, and in particular introduced a transitional period for the deadline within which to submit a request for an extension of the supplementary protection certificate.


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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco