While the world is preoccupied with the COVID-19 pandemic, The Japanese government continued an action plan covering all sectors of the country. With the aim of enhancing Japan's readiness to adopt "regenerative medicine" technologies, It is the science of activating the body's self-repair mechanisms for the treatment of diseases whose treatment was not possible by traditional medical means. In order to enable the mechanisms of application and development of this field, Japan has adopted a three-pronged approach, Starting with the governing laws, Then support manufacturing, and enhance readiness.
Regenerative medicine is a branch of research that specializes in translating tissue engineering and molecular biology to alter and regenerate human cells, tissues and organs to treat them from disease or injury. Like any innovative sector, it needs supportive and regulatory policies to achieve optimal outcomes in the context of patient needs and organizational and societal determinants. In a country with a history of medical innovation like Japan, Stem cell therapy has been receiving government support since the turn of the millennium. Beginning with funding medical research and issuing regulatory guidelines for clinical trials, Japanese scientists from Kyoto University were even awarded the Nobel Prize for discovering a new type of stem cell.
In order to take advantage of this technology of Japanese origin and establish an industry qualified for global competition, The Government of Japan has adopted the so-called "Regenerative Medicine Preparedness" plan. Based on the idea that the development of new cell- and gene-based therapies is important to initiate regular and expanded use of regenerative medicine as a viable option, But such a goal requires intensive government efforts to raise institutional capacity and provide the necessary infrastructure, organization and training. Especially after the demands of Japanese scientists to reconsider the regulatory framework to enable it to absorb new technological means in treatment.
To this end, With the active contribution of the Japanese Society of Regenerative Medicine, The Japanese government has begun work to establish a skills-based economic and regulatory environment for the deployment of regenerative medicine on a comprehensive national level. This means a whole system in which government, industry and academia collaborate. The beginning was in 2014, When two laws regulating regenerative medicine were issued, The first of these was the law on medicines, medical devices and other therapeutic products, It is the most traditional law between them, Whereas, it is an update of the previous Pharmacy Law, It contains explicit provisions on the licensing and market access of regenerative medicine products developed by manufacturers, Then it is required to prove the safety and effectiveness of the products within a maximum period of 7 years, To be extended or revoked. The second law is the Regenerative Medicine Safety Act. This differs in that it is a parallel organization of research and clinical uses of regenerative medicine in hospitals in contrast to the research of companies regulated by the first law. In 2020, Japan's Ministry of Health, Labor and Welfare has approved several regenerative treatments and drugs targeting diseases such as retinitis pigmentosa. spinal muscular atrophy, corneal epithelial stem cell deficiency, Which was the first eye condition to be licensed to be treated with regenerative medicine.
Following the legal amendments, Efforts were directed towards increasing industrialization, It focused on standardizing quality standards and reducing the cost of manufacturing regenerative medicine in all its forms, Granting membership of the Japan Industry Association to logistics service providers, insurance companies, therapeutics developers and start-ups within the field, Then it turned to the development of human capital, By launching training and qualification programs, preparing curricula for those concerned with regenerative medicine, and granting certificates to cell transplant specialists.
At the community level, Japan has launched various activities to bring academia and industry closer together. With the participation of patient organizations, In addition to holding awareness lectures. To further enhance readiness, The Japan Industry Association, sponsored by the Japan National Medical Research Funding Agency (AMED), has established a national consortium to support clinical research, regenerative therapy, education and regulatory consulting, and developed a national registry to be a database of all that has been produced by clinical research and post-marketing monitoring studies.
Although there is a special regulation that allows regenerative medicine treatments to be provided to some patients for profit before obtaining final approval, This point was not a difficult challenge, The application of this "conditional consent" is possible after the completion of the second phase of clinical trials, After ensuring accurate predictions of safety and efficacy rates based on available trial data.
On the other hand, The Japanese government has faced warnings that major pharmaceutical makers will stay away from the Japanese market if wrong policies are applied regarding drug pricing regulations. But it continues to adjust drug pricing as it seeks to cut healthcare spending. It plans to meet this challenge by strengthening its position as a destination for multinational pharmaceutical companies developing regenerative medicine therapeutics. and support more research and development in this field.
The desired effect of the Regenerative Medicine Safety Act was to control cell- and tissue-based products, At the same time, it has been reflected in supporting innovation in clinical research as a means of developing new treatments in Japan, This is within an organized framework. On the executive side, The development of mass industrial production capacity was essential to the delivery and widespread delivery of regenerative medicine treatments, The great momentum of manufacturing has also contributed to making the most of locally sourced technology and developing a sector with global qualifications, In addition to establishing regenerative medicine as a cross-sectoral field by offering membership of the Japan Industry Association. In turn, The National Register is a rich reference with evidence and studies related to the safety and effectiveness of regenerative medicine treatments.
Experience also shows that some initiatives are applicable in other countries, Others remain possible only within the current reality of Japan's society and health system.