Japan: A Life Sciences Overview
The legal regime regulating the life sciences sector in Japan consists of a wide range of rules and regulations stipulated in statutes enacted by the Diet, guidance published by relevant regulatory authorities, and industry rules established by industry organisations. These rules and regulations undergo constant review and updating; thus, accurate comprehension of the legal and regulatory landscape in Japan requires a correct understanding of the most current discussions and developments concerning the rules and regulations affecting the Japanese life sciences industry. We set out below some of the key recent developments.
Major Revision of Pharmaceuticals and Medical Devices Act
On 14 May 2025, the revised Pharmaceuticals and Medical Devices Act (PMD Act) was enacted. This is the first major revision in six years, and it aims to ensure and promote access to pharmaceuticals and other medicinal products from various perspectives. For example, from the standpoint of ensuring quality and safety, a new measure has been introduced that allows the regulatory authority to change the relevant officers responsible for the business relating to pharmaceutical regulations in question (eg, representative directors). While this measure was not adopted in the 2019 revision, it has now been implemented based on the regulatory concern that top management have often been involved in recent non-compliance cases. In response to the recent issues of unstable supply of pharmaceuticals, particularly generic drugs, marketing authorisation holders will be required to establish systems for stable supply management. This includes appointing a statutory manager responsible for stable supply and preparing relevant standard operating procedures (SOPs).
To address the problem of delays in introductions of novel products into Japan, the conditional approval system has been partially revised. Various pharmaceutical sales regulations have also been revised, such as lifting the ban on outsourcing certain pharmacy operations and expanding methods for remote sales of over-the-counter (OTC) drugs. The revised Act will come into effect in stages within three years.
Medical DX and the Promotion of Self-Medication Under Policy 2025
On 13 June 2025, the Japanese Cabinet approved the Basic Policy on Economic and Fiscal Management and Reform 2025 (“Policy 2025”). Policy 2025 outlines a shift from providing medical services through traditional paper-based health insurance cards to providing them primarily through the My Number Card (“My Number ID”), a digital ID accessible to all Japanese citizens by December 2025. Using the My Number ID to provide medical services will enable the development of a national medical information platform and promote the sharing of electronic medical records. By the end of March 2026, the government will outline the details of the standard electronic medical record system.
In Japan, nearly all prescription drugs are covered by public health insurance, and patients pay only a small amount for medications. To reduce the financial burden on health insurance, Policy 2025 recommends expanding coverage for OTC drugs by switching more prescription drugs and diagnostics to OTC status. The policy also encourages self-care and self-medication through the use of OTC drugs, for which patients will pay. According to a Nikkei newspaper analysis, around 5% of all prescription drugs in Japan are OTC drugs that are prescribed and reimbursed by public health insurance.
Patentability of Compositions Which Anticipate Medical Procedures Both Before and After Manufacture
On 19 March 2025, the Grand Panel of the Intellectual Property High Court rendered their judgment in a patent infringement case. The court reversed a Tokyo District Court’s judgment and found that the defendant had infringed the plaintiff’s patent. This case was subject to the third-party opinion solicitation system (the Japanese version of amicus curiae brief).
Although the Patent Act of Japan has no specific provision that explicitly denies patentability for medical procedures, in court precedents and actual Japanese patent examinations, it is generally interpreted that a method of surgery, therapy, or diagnosis of humans conducted by a doctor (so-called medical activity) does not fall under “an industrially applicable invention” (Article 29(1) of the Patent Act) and is therefore not patentable.
This judgment affirms that “product inventions” requiring medical procedures before and after manufacturing can be qualified as “industrially applicable inventions” under the Patent Act.
The judgment also clarifies that compositions intended primarily for aesthetic purposes do not qualify as “substances used for diagnosis, therapy, treatment or prevention of human diseases” under Article 69(3) of the Patent Act, which provides for an exemption that limits effects of patent rights.
Cannabis Control Act Amendment: Component-Based Control, Use Offence and Rebuilt Licensing
Japan’s 2025 amendment pivots cannabis regulation from a parts-based approach to a component-focused model centred on delta-9-THC. The design’s core is a two-tier framework: residual THC thresholds are specified by Cabinet Order; products exceeding those limits are treated as “narcotics” under the Narcotics and Psychotropics Control Act and face full narcotics controls, while products at or below the limits are excluded from narcotics regulation. The approach enables compliant low-THC products to circulate, yet preserves stringent measures for high-THC items and improves regulatory clarity for market participants. This shift aligns Japan with potency-based regimes seen elsewhere.
Concurrently, the amendment establishes a standalone use offence. Cannabis is positioned as a narcotic for enforcement purposes, and unauthorised administration, including self-use, is prohibited. Penalties are harmonised with analogous narcotics offences, with the use offence generally capped at imprisonment of up to seven years. By addressing use itself, authorities gain tools to respond to cases where proving possession is evidentially difficult.
Finally, the statute is retitled the Act on Regulation of the Cultivation of Cannabis Plants and rebuilt around lawful supply. The licensing regime is stratified by purpose and risk across cultivation, processing, and research, with tailored competent authorities, validity periods, and technical safeguards for three pillars: industrial use, medical raw material supply, and research cultivation.
Guidelines Concerning Non-Clinical Direct-to-Consumer (DTC) Testing Services
In March 2025, the Ministry of Health, Labour and Welfare (MHLW) and Ministry of Economy, Trade and Industry (METI) published their revised guidelines on new business activities related to extending healthy life expectancy, which contain important updates to clarify the regulations concerning non-clinical DTC testing services. Japan does not currently have specific laws regulating such services, and as the use of these testing services (eg, genetic testing, blood testing and urinalysis) expands, there are increased regulatory concerns around the quality and credibility of these services.
Clarifying the legal regulations regarding non-clinical DTC testing services was raised as one of the policy recommendations listed in the White Paper on Strengthening Japan’s Healthcare Startup Ecosystem published by MHLW’s Project Team on Healthcare Startup Acceleration in June 2024. Based on these initiatives, MHLW and METI jointly published the revised guidelines, which contain detailed guidance on permissible and non-permissible testing services. For example, the revised guidelines provide that there is a risk of violation of the Medical Practitioners’ Act (which requires a physician licence in order to provide medical services) in the case where the test result provided to the consumer lacks publicly known scientific evidence. It is expected that the updated guidance will contribute to the sound growth and development of the testing business.