| Author (Corporate) | European Commission |
|---|---|
| Series Title | COM |
| Series Details | (2017) 626 final (26.10.17) |
| Publication Date | 26/10/2017 |
| Content Type | Policy-making, Report |
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Further information: The report provides an account of the Regulation's achievements, both in public health and economic terms, and an analysis of the extent to which its objectives have been met. The document builds on a 10-year report prepared by the European Medicines Agency (EMA) and its Paediatric Committee, an external study on the Regulation’s impact ordered by the Commission, a public consultation, and discussions with Member States, the European Parliament, patients, companies, interested parties and external partners about their experiences of the Regulation’s impact. Background information: Nowadays there is broad consensus that children deserve access to medicines that have been specifically developed and researched for use in young patients. However, until recently the development and testing of paediatric medicines was far from satisfactory. Many of the products used in children were prescribed and administered based on physicians’ own experience rather than on the results of clinical research. Moreover, medicines were often not available in a pharmaceutical form suitable to children. Paediatricians had to turn to medicines authorised for adults by adapting the dosage and form, for example by crushing adult tablets and using only a portion. This off-label use of adult medicines comes with the risk of inefficacy and/or adverse reactions in children. Side effects that may not affect adults can be important and serious in children. Regulation (EC) No 1901/2006 on medicinal products for paediatric use (the 'Paediatric Regulation') was adopted to address this problem. Legislative intervention was deemed necessary to reverse previous trends. A consultation and discussion process that lasted several years was the basis of the legislation. It was also inspired by developments in the United States, which started legislative approaches to address paediatric product development in the late 1990s. The European Commission published on 26 October 2017 a report to mark the 10th anniversary of the Paediatric Regulation. |
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| Source Link | Link to Main Source http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2017:626:FIN |
| Related Links |
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| Subject Categories | Geography, Health |
| Countries / Regions | Europe |
