MHLW adds three substances to designated drugs list effective Nov 6

The Ministry of Health, Labour and Welfare promulgated Ministry of Health, Labour and Welfare Ordinance No. 150 in the Official Gazette dated October 27, 2026, adding three substances to the designated substances based on Article 2, Paragraph 15 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960). As per the supplementary provisions, it will come into effect on November 6, ten days after the date of promulgation, and the number of designated substances will increase from 366 to 369. The promulgation was made by Kenichiro Ueno, Minister of Health, Labour and Welfare.

The target of the amendment is Ministry of Health, Labour and Welfare Ordinance No. 14 of 2007 (Ministerial Ordinance Establishing Designated Substances Prescribed in Article 2, Paragraph 15 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and Medical Uses Prescribed in Article 76-4 of the Same Act). This ordinance defines the list of designated substances and the medical uses prescribed in Article 76-4 of the Act; the current amendment inserts new items into the list and shifts subsequent items downward. The supplementary provisions consist of a single sentence establishing the effective date, and no transitional measures have been provided.

The Three Added Substances and Their Item Positions

The following three substances were marked as “Newly Established” in the amendment table of the Official Gazette, all of which are designated including their salts.

• Item 65: 1-(ethylamino)ethyl-5-nitro-2-(4-propoxybenzyl)benzimidazole and its salts
• Item 99: N-ethyl-5-methoxy-N-methyltryptamine and its salts
• Item 286: 8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-fluorobenzoate and its salts

The chemical structure systems are divided into three types: those with a benzimidazole skeleton, those of the tryptamine series, and an ester with an azabicyclo skeleton. Because the phrase “and its salts” is attached, preparations or reagents distributed in the form of salts of each substance also fall under the same designation.

Existing Items Shift Downward in Three Places

In the amendment table, all existing items following the newly established items are shifted backward.

• Items 65 to 97 before the amendment (33 items) move to Items 66 to 98 after the amendment.
• Items 98 to 283 before the amendment (186 items) move to Items 100 to 285 after the amendment.
• Items 284 to 366 before the amendment (83 items) move to Items 287 to 369 after the amendment.

The end of the list will now consist of items No. 366 through No. 369 (prior to the amendment), and this addition is limited to three items. Because the item numbers themselves will change, businesses that cite these numbers in internal regulations, product labels, or test records will be forced to update their reference numbers.

Ten-Day Notice Period and Impact on Industry Practice

There are only ten days between promulgation and enforcement. Since designated substances are subject to regulation under the same law, businesses and research institutions that handle the relevant substances as raw materials, reagents, or standard samples must complete the cross-referencing of their inventory and reagent lists by November 6. Because the designation includes salts, items stored as salts (not just free bases), mixed preparations, and analytical standards are also subject to inspection.

In the industry, the import and sale of chemicals, contract testing, and reagent management at universities and research institutions will be directly affected. The fact that reference numbers for existing substances will no longer match internal documents due to the shifting of item numbers will also be a practical point of contention. The provisions for medical use, etc., based on Article 76-4 of the same law, do not appear in this amended table, and changes are limited to the list of designated substances.

Source

• Official Gazette, published Tuesday, October 27, 2026, Ministry of Health, Labour and Welfare Ordinance No. 150
• Subject of Amendment: Ministry of Health, Labour and Welfare Ordinance No. 14 of 2007 (Ministerial Ordinance Establishing Designated Substances as Prescribed in Article 2, Paragraph 15 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and Medical Use, etc. as Prescribed in Article 76-4 of the Same Act)
• Legal Basis: Act No. 145 of 1960, Article 2, Paragraph 15, and Article 76-4
• Promulgated: October 27, 2026, Minister of Health, Labour and Welfare, Kenichiro Ueno
• Enforced: The day on which ten days have elapsed from the date of promulgation (November 6)