Non-biological complex drugs (NBCDs) such as nanomedicines have not been recognized as a separate category of pharmaceuticals, so no formal route or method for regulatory approval has been defined. This can lead to great difficulties in copying NBCD products as generic drugs after the market exclusivity of the original product expires. Therefore, in order to more efficiently identify the development trends of subsequent NBCD products, we compared the regulatory guidelines for NBCD in effect in the European Union and the United States, and 21 out of 24 products recognized as NBCD by GAO, NBCD Working Group, and NIH. We selected and investigated the approval process for each nanoparticle. Accordingly, the EU\'s centralized procedures (CP) and non-centralized procedures were confirmed through research. In this case, when following a non-centralized procedure, the generic application procedure according to Article 10(1) of Directive 2001/83/EC was mainly used in relation to the legal basis. However, it has recently been confirmed that the frequency of approval of hybrid routes under Article 10(3) is increasing. US: Federal Food, Drug, and Cosmetic Act; A generic product of NBCD is approved under section 505(j) of the FD&C Act (21 U.S.C. 355(j)). As the details required by each regulatory authority in terms of non-clinical and clinical aspects and approval path may be different, the overall guidelines and guidelines for each product have been organized.