How Japan Regulates Novel Psychoactive Substances

Last edited: 2026-07-24

Sun Pin / Attorney-at-law, former pharmacist

Tomorrow, the Legislative Yuan will review the Executive Yuan's draft amendment for partial articles of the Narcotics Hazard Prevention Act. To address the continuous emergence of novel psychoactive substances (NPS), the Executive Yuan's draft expands the definition of narcotics. It relaxes the original statutory requirements that a substance must possess "addictiveness, abuse potential, and social harm" to having "the potential for" addictiveness, abuse potential, and social harm. Furthermore, to enable the rapid, blanket listing of substances on a large scale, the definition of narcotics is expanded to encompass novel substances with "similar chemical structures." The Executive Yuan cited the Japanese legal system as the reference for this legislative proposal. But is that really the case?

Japan's regulation of novel psychoactive substances is divided into three tiers. Tier 1: When a substance is discovered and it is uncertain whether it will stimulate, depress, or hallucinate the central nervous system, Japan regulates it under the provisions for "unapproved pharmaceuticals" in its Pharmaceutical Affairs Act. This is equivalent to the regulation of "fake drugs" or "prohibited drugs" under our Pharmaceutical Affairs Act.

Tier 2: When a substance is highly likely to stimulate, depress, or hallucinate the central nervous system, and its use on humans may pose a hazard to public health and hygiene, Japan regulates it under the provisions for "designated substances" in its Pharmaceutical Affairs Act. The designated substance system also incorporates "comprehensive designation," which allows substances with the same core chemical structure to be listed simultaneously in one go.

Tier 3: When the harmfulness of a substance has been confirmed by scientific research and is determined to be very high, Japan lists these substances individually under its "Four Narcotics Laws" (the Narcotics and Psychotropics Control Act, the Opium Act, the Cannabis Control Act, and the Stimulants Control Act). This is equivalent to listing substances as narcotics under Taiwan's Narcotics Hazard Prevention Act.

As shown above, Japan's regulation of novel psychoactive substances progressively elevates the regulatory tier based on the level of harm and the degree to which scientific research has confirmed that harm. The higher the tier, the heavier the penalties. Only substances proven by scientific research to be definitively and highly harmful are treated as narcotics and placed in the final tier, subject to severe criminal punishment.

In contrast, the Executive Yuan's draft amendment claims to reference Japan's designated substance system, yet completely lacks a tiered regulatory framework akin to Japan's legal system, opting instead for a sweeping relaxation of the definition of narcotics. Whether a substance is known to be harmful, potentially harmful, or even has completely unclear effects, they are all lumped together indiscriminately into the Narcotics Hazard Prevention Act. The author suggests that if there is a genuine intention to reference the Japanese legal system in regulating novel psychoactive substances, the Executive Yuan and the Legislative Yuan should further examine the regulatory framework and underlying legislative logic of Japanese law. Only then can the legislative amendments be comprehensive and avoid future complications.

※ This article was published in the Apple Daily on May 8, 2018

This article is an AI-generated translation of the original Chinese text. In the event of any discrepancy, the Chinese version shall prevail.

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