Industry Coverage Pharmaceuticals, Medical Care, Health Care and Biotechnology

At TMI, we provide corporations and start-ups expanding globally in the life sciences and medicine fields with comprehensive and practical legal advice on establishing business, licensing, public offerings, mergers and acquisitions (M&A) and litigation.

As for pharmaceutical and healthcare products, in addition to patent and trademark- related services, we provide legal advice on the applicable laws and regulations such as the Pharmaceutical Affairs Act and the Anti-monopoly Law.  These laws and regulations are related to the development, production, sales, distribution, promotion, advertising and pricing of pharmaceutical products, medical devices, quasi-drugs, cosmetics, health foods, foods specified as for health use and so on.

As for medical care, we provide practical advice based on the Medical Practitioners Act, Medical Service Act and other related laws for leading-edge technology such as regenerative medicine, remote medical care and medical-related information services and so on.

As for biotechnology, we provide practical advice based on the relevant laws and regulations including various guidelines related to research and development on leading-edge technology such as stem cell and biotechnology-based medicine, biosimilars and so on.

For pharmaceuticals, medical care, health care and biotechnology-related issues,  professionals well-versed in areas such as intellectual property, bio business, pharmaceuticals, M&A, finance, the Anti-monopoly Law, insurance, risk management and other related fields are here to provide you with advice.   We also have knowledgeable professionals who have math and science backgrounds including chemistry, pharmaceutical sciences, biotechnology, nanotechnology and other sciences.  Finally, attorneys with medical licenses can provide you with advice on legal issues related to pharmaceuticals and medical services.

We would like to utilize our vast knowledge and experience to be proactively involved in the fields of regenerative medicine, biotechnology and nanotechnology, which are leading the industry into the 21st century. 

Attorneys in this Practice Area

Related Articles and Publications

2020/06/19ARTICLE “Japan – Health and Pharma Overview”
2019/12/01ARTICLE “Pharma & Medical Device Regulation 2020(Japan)”
2019/03/10ARTICLE “Safety Management and Troubleshooting in Aesthetic Medicine ‘The Act on Specified Commercial Transactions and Aesthetic Medicine’”
2017/06/13ARTICLE “Utilization of Medical Big Data Based on the Amended Personal Information Protection Act in Japan”
2015/06/19ARTICLE “[Serial Article] Forefront of the Healthcare Business – Issue 4: Laws and Regulations Relating to Nursing-Care Robots”

Related Seminars and Lectures

2020/02/07MONTHLY TMI Associates’ 139th monthly seminar: “2019 Amendment to the PMD Act and the Regulations on Pharmaceutical Advertisements – In View of the Introduction of the Surcharge System”
2020/01/31EXTERNAL “Legal Affairs in the Utilization of Healthcare Data – Comprehensive Explanation of Legal Regulations and Guidelines, such as the Act on the Protection of Personal Information and Information Security, and Specific Examples of Utilization”
2019/10/28EXTERNAL “Legal Issues in the Utilization of Medical Big Data in the Insurance, Healthcare, and Genome Fields”
2019/09/05EXTERNAL “No. 4014: Legal Affairs Regarding the Utilization of Medical Big Data – Including Notable Points for Global Expansion”
2019/05/28EXTERNAL “Notable Points from the Legal Perspective Regarding the Protection and Utilization of Healthcare Data and Pitfalls during Further Global Development in View of Intellectual Property Rights and the Act on the Protection of Personal Information”