Regulatory Toxicology in the European Union
CHAPTER 2: Regulation of Medicinal Products for Human Use in the European Union
Published:21 Feb 2018
Special Collection: 2018 ebook collectionSeries: Issues in Toxicology
H. E. Stemplewski, in Regulatory Toxicology in the European Union, ed. T. Marrs and K. Woodward, The Royal Society of Chemistry, 2018, pp. 22-71.
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There is a considerable body of legislation governing the regulation of human medicinal products in the European Union. This legislation has evolved over the last fifty years, and it continues to evolve. The legislation is supported where necessary by scientific guidelines, including guidelines concerning safety aspects of medicines. The evaluation of human medicines is conducted through expert committees and subsidiary groups which cover all aspects of quality, safety and efficacy. This chapter discusses the evaluation of human medicinal products and the processes that lead to them gaining access to the commercial market, as well as the processes in place to ensure that marketed products continue to be monitored once in use.