The Pharmaceutical Affairs Law (PAL) introduced the so‐called “designated substances” in 2007. According to this regulation, the control of new substances undergoes a three step process. The first two steps are guided by the PAL. The first step encompasses identification of non‐approved or unauthorized pharmaceuticals, whereas the second step classifies them into designated substances, controlling its manufacture, import, sale, storage and display of “Designated Substances”. Since April 2014, the possession, purchase, receive and use of them have also been prohibited. It is important to note that the competent authority can designate substances it based on fewer data than those needed under the narcotics or psychotropics law. Substances that have been identified in other countries can also be controlled before they reach the market in Japan. The third step is regulated under the Narcotics and Psychotropics Control Law with the objective of prohibiting its distribution, possession and use, reclassifying the designated substance into narcotics. For instance, mephedrone was placed under control in 2009 by including it in the PAL, but in 2012 it was added to the list of controlled narcotics of the Narcotics and Psychotropics Control Law. Between September and November 2014, other 22 NPS were added to the list of "designated substances", including ADB-CHMINACA, 5Cl-AB-PINACA, DP-UR-144, etc. By July 2016, there were 2345 "designated substances" in Japan. An example of a designated substance can bee seen here.