Regulation

Japan's three newly designated drug substances take effect on 6 November

The October ordinance adds N-Desethyl Protonitazene, 5-MeO-MET and 2-F-tropacaine, including their salts, to Japan's controlled designated-drug list.

Japan's Ministry of Health, Labour and Welfare promulgated Ministerial Ordinance No. 150 of 2026 on 27 October; it took effect on 6 November 2026. It adds three substances commonly identified as N-Desethyl Protonitazene, 5-MeO-MET and 2-F-tropacaine, together with their salts, to the designated-drug list under the Pharmaceuticals and Medical Devices Act. The ministry's implementation notice also covers materials containing any of them, with an exception for plants that naturally contain the substance.

Illustration for Japan's three newly designated drug substances take effect on 6 November

After the effective date, manufacture, import, sale, possession and use for purposes other than specified medical or related purposes are prohibited. The ministry's annex and notice provide the formal chemical names and scope. This amendment adds controlled substances; it does not prescribe a new analytical method, quantification limit or screening threshold. The published materials state no transition period for the additions.

Forensic and toxicology laboratories should reconcile their target lists, identification libraries and reference-material scope against the formal names and salts in the implementation notice. The legal handling of reference materials and samples for a particular laboratory purpose needs to be checked separately.