Development of the Regulatory Framework for Regenerative Medicine and Progress Toward Commercialization
First written in FY2017-Q1. 16 of 31 entries say "Restated". Latest entry: FY2027-H1.
0 other companies' latest entry also says "Restated".
- FY2027-H1RestatedAnnual report
「In Japan's regenerative medicine industry, commercialization of regenerative medicine products is advancing under the Act on the Safety of Regenerative Medicine and the revised Pharmaceutical and Medical Devices Act. In the United States, expedited approvals are also being pursued under the RMAT program based on the 21st Century Cures Act. Thus, regulatory development and commercialization of regenerative medicine are advancing in both Japan and the United States.」
The view of the business environment that regulatory development and commercialization of regenerative medicine are advancing in Japan and the United States was reaffirmed. - FY2026AdvancedAnnual report
「By the end of January 2026, 23 products had received marketing approval as regenerative medicine products, and a further 2 products received such approval in February 2026.」
The number of approved regenerative medicine products in Japan reached 23 by the end of January 2026, with a further 2 products approved in February 2026. - 2026-03-17AdvancedRevision of earnings forecasts
「By the end of January 2026, 23 products had obtained manufacturing and marketing approval as regenerative medical products, followed by 2 additional products in February 2026.」
The company reported 23 approved regenerative medical products by the end of January 2026 and 2 additional products approved in February 2026. - FY2026-H1AdvancedAnnual report
「In Japan's regenerative medicine industry, as industrial promotion of regenerative medicine advanced under the Act on the Safety of Regenerative Medicine and the revised Pharmaceutical and Medical Devices Act, 21 products had received marketing approval as regenerative medicine products by the end of July 2025. In the United States, the RMAT (Regenerative Medicine Advanced Therapy) designation program was established under the 21st Century Cures Act, passed in December 2016, to enable expedited approval of regenerative medicine products intended to treat serious diseases. In 2021, 3 RMAT-designated products, including the first RMAT-designated product to receive BLA (Biologics License Application) approval, received BLA approval, and in 2025, 1 RMAT-designated product received BLA approval.」
New progress in commercialization was reported: 21 products had received approval in Japan by the end of July 2025, while 1 RMAT-designated product received BLA approval in the United States in 2025. - FY2025AdvancedAnnual report
「In Japan's regenerative medicine industry, as industrial promotion of regenerative medicine advanced under the Act on the Safety of Regenerative Medicine and the revised Pharmaceutical and Medical Devices Act, 21 products had received marketing approval as regenerative medicine products by the end of January 2025.」
The number of regenerative medicine products receiving marketing approval in Japan increased from 20 by the end of July 2024 to 21 by the end of January 2025. - FY2025-H1AdvancedAnnual report
「In Japan's regenerative medicine industry, as industrial promotion of regenerative medicine advanced under the Act on the Safety of Regenerative Medicine and the revised Pharmaceutical and Medical Devices Act, which took effect in November 2014, 20 products had received marketing approval as regenerative medicine products by the end of July 2024. In the United States, the RMAT (Regenerative Medicine Advanced Therapy) designation program was established under the 21st Century Cures Act, passed in December 2016, to enable expedited approval of regenerative medicine products intended to treat serious diseases. In 2021, 3 RMAT-designated products, including the first RMAT-designated product to receive BLA (Biologics License Application) approval, received BLA approval, and in 2024, 3 RMAT-designated products received BLA approval.」
The number of approved products in Japan stood at 20 by the end of July 2024, while the number of RMAT-designated products receiving BLA approval in the United States in 2024 was updated from the previously reported 2 to 3. - FY2025-Q1AdvancedAnnual report
「In Japan's regenerative medicine industry, as industrial promotion of regenerative medicine advanced under the Act on the Safety of Regenerative Medicine and the revised Pharmaceutical Affairs Law, which took effect in November 2014, 20 products had received marketing approval as regenerative medicine products by the end of April 2024. In the United States, the RMAT (Regenerative Medicine Advanced Therapy) designation program was established under the 21st Century Cures Act, passed in December 2016, to enable expedited approval of regenerative medicine products intended to treat serious diseases. In 2021, 3 RMAT-designated products, including the first RMAT-designated product to receive BLA (Biologics License Application) approval, received BLA approval, and in 2024, 2 RMAT-designated products received BLA approval. Thus, the commercialization of regenerative medicine continues to make steady progress in Japan and the United States.」
New milestones were reported: 20 products had received approval in Japan by the end of April 2024, while 2 RMAT-designated products received BLA approval in the United States in 2024. - FY2024AdvancedAnnual report
「In 2023, 4 RMAT-designated products received BLA approval and 17 products were newly granted RMAT designation. Thus, 2023 saw continued progress toward the commercialization of regenerative medicine in Japan and the United States.」
As 2023 results, 20 products had been approved as regenerative medicine products in Japan by the end of 2023, while in the United States, 4 RMAT-designated products received BLA approval and 17 products were newly granted RMAT designation. - FY2024-Q3AdvancedAnnual report
「In 2023, as of the end of October, 3 products in Japan had received marketing approval as regenerative medicine products, while 2 RMAT-designated products in the United States had received BLA approval, and the commercialization of regenerative medicine continued to make steady progress.」
New milestones were reported: 3 products had received approval in Japan as of the end of October 2023, while 2 RMAT-designated products had received BLA approval in the United States. - FY2024-Q2AdvancedAnnual report
「In 2023, as of the end of July, 3 products in Japan had already received marketing approval as regenerative medicine products, and the commercialization of regenerative medicine continued to make steady progress.」
The number of regenerative medicine products receiving marketing approval in Japan increased from 2 as of the end of April 2023 to 3 as of the end of July 2023. - FY2024-Q1AdvancedAnnual report
「In Japan's regenerative medicine industry, as industrial promotion of regenerative medicine advanced under the Act on the Safety of Regenerative Medicine and the revised Pharmaceutical Affairs Law, which took effect in November 2014, 17 products had received marketing approval as regenerative medicine products by the end of 2022.」
A new milestone of 17 products receiving marketing approval as regenerative medicine products in Japan by the end of 2022 was reported. It was also explained that 2 products in Japan had received approval as of the end of April 2023. - FY2023AdvancedAnnual report
「Although no RMAT-designated products received BLA approval in 2022, 14 products were newly granted RMAT designation. Thus, 2022 saw continued progress toward the commercialization of regenerative medicine in Japan and the United States.」
It was explained that 14 products were newly granted RMAT designation in the United States in 2022 and that 3 products were approved as regenerative medicine products in Japan in the same year, updating the facts concerning progress in the regulatory framework and commercialization. - FY2023-Q3AdvancedAnnual report
「In 2022, as of the end of October, 3 products in Japan had already received marketing approval as regenerative medicine products, and the commercialization of regenerative medicine continued to make steady progress.」
The number of regenerative medicine products approved in Japan increased from 2 at the end of July to 3 at the end of October. - FY2023-Q2RestatedAnnual report
「In 2022, as of the end of July, 2 products in Japan had already received marketing approval as regenerative medicine products, and the commercialization of regenerative medicine continued to make steady progress.」
As of the end of July 2022, 2 products had received approval in Japan, reaffirming the view of the business environment that the commercialization of regenerative medicine continues to advance. - FY2023-Q1AdvancedAnnual report
「In Japan’s regenerative medicine industry, the industry has been promoted under the Act on Securing Safety of Regenerative Medicine and the amended Pharmaceutical and Medical Devices Act, which took effect in November 2014. In 2021, a record-high 5 products obtained marketing authorization as regenerative medical products. In the United States, the RMAT designation system was established under the 21st Century Cures Act, passed in December 2016, enabling accelerated approval of regenerative medicine products intended to treat serious diseases. In 2021, 3 products with RMAT designation obtained BLA approval, including the first BLA approval for an RMAT-designated product. In 2022, commercialization of regenerative medicine continued to progress steadily, with 2 products having already obtained marketing authorization as regenerative medical products in Japan as of the end of April.」
In Japan, a record 5 products were approved in 2021, with a further 2 products approved by the end of April 2022. In the United States, 3 RMAT-designated products received BLA approval in 2021, demonstrating further progress in the commercialization of regenerative medicine. - FY2022-Q2RestatedAnnual report
「In Japan’s regenerative medicine industry, the industry has been promoted under the Act on Securing Safety of Regenerative Medicine and the amended Pharmaceutical and Medical Devices Act, which took effect in November 2014. In September 2015, conditional and time-limited marketing authorization for a domestic regenerative medical product was granted for the first time under the new early approval system, and the commercialization of regenerative medical products has been becoming a reality.」
The business environment assessment that regenerative medical products are moving toward commercialization as a result of Japan’s regenerative medicine-related legislation and conditional and time-limited marketing authorization has been reconfirmed. - FY2021-Q3RestatedAnnual report
「In Japan’s regenerative medicine industry, the industry has been promoted under the Act on Securing Safety of Regenerative Medicine and the amended Pharmaceutical and Medical Devices Act, which took effect in November 2014. In September 2015, conditional and time-limited marketing authorization for a domestic regenerative medical product was granted for the first time under the new early approval system, and the commercialization of regenerative medical products has been becoming a reality. In the United States, the 21st Century Cures Act was passed in December 2016.」
The business environment assessment that commercialization of regenerative medicine products is advancing against the backdrop of Japan’s early approval system and the US 21st Century Cures Act and RMAT system has been reiterated. - FY2021-Q1RestatedAnnual report
「In Japan’s regenerative medicine industry, the industry has been promoted under the Act on Securing Safety of Regenerative Medicine and the amended Pharmaceutical and Medical Devices Act, which took effect in November 2014. In September 2015, conditional and time-limited marketing authorization for a domestic regenerative medical product was granted for the first time under the new early approval system, and the commercialization of regenerative medical products has been becoming a reality. In the United States, the 21st Century Cures Act was passed in December 2016.」
The business environment assessment that commercialization of regenerative medicine products is advancing against the backdrop of Japan’s early approval system and the US 21st Century Cures Act and RMAT system has been reconfirmed. - FY2020RestatedAnnual report
「In Japan, the industry has been promoted under the Act on Securing Safety of Regenerative Medicine and the amended Pharmaceutical and Medical Devices Act, which took effect in November 2014. In September 2015, conditional and time-limited marketing authorization for a domestic regenerative medical product was granted for the first time under the new early approval system, and the commercialization of regenerative medical products has been becoming a reality.」
The business environment assessment that commercialization of regenerative medicine products is advancing against the backdrop of Japan’s early approval system and the US 21st Century Cures Act and RMAT system has been reconfirmed. - FY2020-Q3RestatedAnnual report
「In Japan’s regenerative medicine industry, the industry has been promoted under the Act on Securing Safety of Regenerative Medicine and the amended Pharmaceutical and Medical Devices Act, which took effect in November 2014. In September 2015, conditional and time-limited marketing authorization for a domestic regenerative medical product was granted for the first time under the new early approval system, and the commercialization of regenerative medical products has been becoming a reality. In the United States, the 21st Century Cures Act was passed in December 2016.」
The business environment assessment that commercialization and accelerated approvals for regenerative medicine products are advancing against the backdrop of Japan’s early approval system and the US 21st Century Cures Act and RMAT system has been reconfirmed. - FY2020-Q1RestatedAnnual report
「In Japan’s regenerative medicine industry, the industry has been promoted under the Act on Securing Safety of Regenerative Medicine and the amended Pharmaceutical and Medical Devices Act, which took effect in November 2014. In September 2015, conditional and time-limited marketing authorization for a domestic regenerative medical product was granted for the first time under the new early approval system, and the commercialization of regenerative medical products has been becoming a reality. In the United States, the 21st Century Cures Act was passed in December 2016. Under the new legislative framework, regenerative medicine was identified as a new category of advanced therapy, the Regenerative Medicine Advanced Therapy (RMAT) designation, and it is expected that approval systems for regenerative medicine-related products will be developed and the approval of new drugs will be accelerated.」
The business environment assessment that commercialization and accelerated approvals for regenerative medicine products are advancing against the backdrop of Japan’s early approval system and the US 21st Century Cures Act and RMAT system has been reconfirmed. - FY2019RestatedAnnual report
「In Japan’s regenerative medicine industry, the industry has been promoted under the Act on Securing Safety of Regenerative Medicine and the amended Pharmaceutical and Medical Devices Act, which took effect in November 2014. In September 2015, conditional and time-limited marketing authorization for a domestic regenerative medical product was granted for the first time under the new early approval system, and the commercialization of regenerative medical products has been becoming a reality. In the United States, the 21st Century Cures Act was also passed in December 2016.」
The business environment assessment that commercialization and accelerated approvals for regenerative medicine products are advancing against the backdrop of Japan’s early approval system and the US 21st Century Cures Act and RMAT system has been reconfirmed. - FY2019-Q3RestatedAnnual report
「In Japan’s regenerative medicine industry, the industry has been promoted under the Act on Securing Safety of Regenerative Medicine and the amended Pharmaceutical and Medical Devices Act, which took effect in November 2014. In September 2015, conditional and time-limited marketing authorization for a domestic regenerative medical product was granted for the first time under the new early approval system, and the commercialization of regenerative medical products has been becoming a reality. In the United States, the 21st Century Cures Act was passed in December 2016. Under the new legislative framework, regenerative medicine was identified as a new category of advanced therapy, the Regenerative Medicine Advanced Therapy (RMAT) designation, and it is expected that approval systems for regenerative medicine-related products will be developed and the approval of new drugs will be accelerated.」
The business environment assessment that commercialization and accelerated approvals for regenerative medicine products are advancing against the backdrop of Japan’s regenerative medicine-related legislation and early approval system, and the US 21st Century Cures Act and RMAT designation, has been reconfirmed. - FY2019-Q2RestatedAnnual report
「In Japan’s regenerative medicine industry, the industry has been promoted under the Act on Securing Safety of Regenerative Medicine and the amended Pharmaceutical and Medical Devices Act, which took effect in November 2014. In September 2015, conditional and time-limited marketing authorization for a domestic regenerative medical product was granted for the first time under the new early approval system, and the commercialization of regenerative medical products has been becoming a reality. In the United States, the 21st Century Cures Act was passed in December 2016. Under the new legislative framework, regenerative medicine was identified as a new category of advanced therapy, the Regenerative Medicine Advanced Therapy (RMAT) designation, and it is expected that approval systems for regenerative medicine-related products will be developed and the approval of new drugs will be accelerated.」
The business environment assessment that commercialization and accelerated approvals for regenerative medicine products are advancing against the backdrop of Japan’s regenerative medicine-related legislation and early approval system, and the US 21st Century Cures Act and RMAT designation, has been reconfirmed. - FY2018-Q3RestatedAnnual report
「In the United States, the 21st Century Cures Act was passed in December 2016. Under the new legislative framework, regenerative medicine was identified as a new category of advanced therapy, the Regenerative Medicine Advanced Therapy (RMAT) designation, and it is expected that approval systems for regenerative medicine-related products will be developed and the approval of new drugs will be accelerated.」
In addition to Japan’s regulatory developments, the outlook for regenerative medicine to be categorized under the RMAT designation pursuant to the US 21st Century Cures Act and for approvals to be accelerated has been reconfirmed. - FY2018-Q2AdvancedAnnual report
「In the United States, the 21st Century Cures Act was passed in December 2016. Under the new legislative framework, regenerative medicine was identified as a new category of advanced therapy, and it is expected that approval systems for regenerative medicine-related products will be developed and the approval of new drugs will be accelerated.」
In addition to Japan’s regulatory developments, the explanation now includes the passage of the 21st Century Cures Act in the United States and the expected development and acceleration of approval systems for regenerative medicine-related products. - FY2018-Q1RestatedAnnual report
「Against the backdrop of regenerative medicine-related legislation and conditional and time-limited marketing authorization, the commercialization of regenerative medical products is becoming a reality.」
The business environment assessment that regenerative medical products are moving toward commercialization against the backdrop of regenerative medicine-related legislation and conditional and time-limited marketing authorization has been reconfirmed. - FY2017RestatedAnnual report
「Against the backdrop of regenerative medicine-related legislation and conditional and time-limited marketing authorization, the commercialization of regenerative medical products is becoming a reality.」
The business environment assessment that commercialization is advancing against the backdrop of regenerative medicine-related legislation and conditional and time-limited marketing authorization has been reconfirmed. - FY2017-Q3RestatedAnnual report
「Against the backdrop of regenerative medicine-related legislation and conditional and time-limited marketing authorization, the commercialization of regenerative medical products is becoming a reality.」
The business environment assessment that regenerative medical products are moving toward commercialization against the backdrop of regenerative medicine-related legislation and conditional and time-limited marketing authorization has been reconfirmed. - FY2017-Q2RestatedAnnual report
「In the regenerative medicine industry, Japan’s regenerative medicine industry has been promoted under the Act on Securing Safety of Regenerative Medicine and the amended Pharmaceutical and Medical Devices Act, which took effect in November 2014. In September 2015, conditional and time-limited marketing authorization for a domestic regenerative medical product was granted for the first time under the new early approval system, and the commercialization of regenerative medical products has been becoming a reality.」
The business environment assessment that regenerative medical products are moving toward commercialization as a result of regenerative medicine-related legislation and conditional and time-limited marketing authorization has been reiterated. - FY2017-Q1First statedAnnual report
「As Japan’s regenerative medicine industry has been promoted under the Act on Securing Safety of Regenerative Medicine and the amended Pharmaceutical and Medical Devices Act, which took effect in November 2014, the commercialization of regenerative medical products has been becoming a reality. In September 2015, for the first time, conditional and time-limited marketing authorization under the new early approval system was granted to 2 regenerative medical products in Japan.」
The company describes the enactment of regenerative medicine-related legislation and the conditional and time-limited marketing authorization of 2 products as part of the business environment surrounding its development activities.