Pharmatching GmbH, Freiburg, Germany.
MAbs. 2011 May-Jun;3(3):241-2. doi: 10.4161/mabs.3.3.15474. Epub 2011 May 1.
In principle, there are three defined procedures to obtain approval for a medicinal product in the European Union. As discussed in this overview of the procedures, the decision on which regulatory pathway to use will depend on the nature of the active substance, the target indication(s), the history of product and/or the marketing strategy.
原则上，在欧盟获得药品批准有三种规定程序。正如本文对这些程序的讨论，对采用哪种监管途径的决定将取决于活性物质的性质、目标适应证、产品的既往史和/或营销策略。
