Legal & Regulatory > Japan

The key facts about biosimilars and biologics in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 75.   1. Are biosimilar medicines considered the same as generic medicines in your country? A biosimilar medicine is differentiated from a generic medicine in the point that final biosimilar products possibly differ from the original product, depending on the manufacturing process. This…

The key facts about localization in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 75.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? No, there are no rules or regulations requiring and/or encouraging localization in Japan. This means that the decision…

The ins and outs of orphan drugs & rare diseases in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99.   1. What is the definition of Rare Diseases in your country? In Japan, there is no fixed definition for Rare Diseases, although the concept is included in the definition of Orphan Drugs (refer to Q2). It should be noted…

Keen to learn more about cannabinoid drugs, medicinal cannabis and opioid drugs in Japan? Read on! Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? No. In Japan, usage of cannabis (all kinds) is severely restricted by two acts. The first is the Cannabis Control Act, under which “Cannabis” is…

The key facts about regulatory reforms in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? There is no significant reform or change to the healthcare system in Japan. However, there are small changes every year. For example, changes due to technology, telemedicine, apps as…

The legal framework for patents and trademarks in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? The Patent Act stipulates that an invention must be novel, non-obvious and have industrial applicability. The Trademark Act allows any trademark unless the mark is the same or similar…

All legal aspects surrounding product liability in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? Liability under contract and liability under tort law are two basic civil liabilities. The liability under tort law, in principle, requires intention or negligence. However, there is a Product Liability Law, under…

A brief overview of the situation regarding traditional medicines and OTC products in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal, complementary, or alternative medicines and devices are subject to the PMD Act.   2. Can these traditional, herbal, complementary, or…

Marketing, manufacturing, packaging & labeling, advertising in Japanese Pharma – a comprehensive legal overview. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? To obtain marketing authorization for new drugs, biologics and medical devices, submission of application to PMDA is…

The low-down on the situation regarding preclinical & clinical trial requirements in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Under the Pharmaceutical and Medical Device Act (PMD Act), in general, clinical trials for application of marketing authorization approval…

An intro to the legal situation for regulatory, pricing and reimbursement in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)   2. What is the…