A Balance Scorecard of the European Paediatric Regulation
DOI:
https://doi.org/10.37285/ijpsn.2014.7.3.4Abstract
Due to the high complexity of testing drugs in children, the of discussion and debate. Some industry experts are of the cost of testing a drug in minors may well exceed the view that the regulation has been a trigger in the area of potential return on investment and, therefore, render it research on pediatric medications while others feel that it is economically unattractive to label drugs for pediatric use. a burden that has been unnecessarily imposed on the As a result, there has been a dearth of drugs for use in manufacturers, hampering the developmental process of children, and in many instances, pediatricians initially had medicines for adults. Through this article, the authors no therapeutic options apart from using drugs off-license havetried to summarize regulation’s main proposals, throw or off-label in European Union (EU). With the advent of light on the respective issues faced by industry, the “Pediatric Regulation” of EU, things have changed. benefits reaped by the pediatric population and pharma- However, over the years, this regulationhas become a topic
Pharmaceutical industry as a whole since its implementation.
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Keywords:
Clinical Trial Directive, Deferral, European Union, Pediatric Investigation plan, Regulation, Waivers.
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References
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