Risks from regulatory changes and obtaining approval for regenerative-inducing medicines
First written in FY2020. 2 of 5 entries say "Restated". Latest entry: FY2025.
StemRIM moved to the "Worse" side of this theme in 2025, 1 year before the typical company in this theme (2026).
The whole theme swung hardest in 2022: 3 of 16 companies on the "Worse" side.
3 other companies' latest entry also says "Worsened".
- FY2025WorsenedAnnual report
「In addition, an amendment to the Act on the Assurance of Safety of Regenerative Medicine that came into effect in May 2025 has further tightened approval reviews for regenerative medicine and gene therapy. This has raised concerns about issues such as longer development periods and higher costs, and may further increase the barriers to commercialization.」
The amendment to the law took effect in May 2025, and concerns about longer development periods and higher costs resulting from stricter approval reviews have become more concrete. - FY2025-H1WorsenedAnnual report
「In addition, the Act on the Assurance of Safety of Regenerative Medicine was amended in 2024, bringing medical technologies using in vivo gene therapy and genome-editing technologies newly within the scope of the law. This is expected to promote the safety of advanced medical technologies.」
The amendment to the Act on the Assurance of Safety of Regenerative Medicine brought in vivo gene therapy and genome-editing technologies newly within the scope of the law. It has also been explained that greater emphasis is being placed on stricter approval reviews for regenerative medicine and gene therapy, as well as on the quality of evidence and the appropriateness of clinical trial designs. - FY2024RestatedAnnual report
「We cannot rule out risks such as previously permitted raw materials suddenly becoming completely unusable due to the enactment or amendment of laws, guidelines or other regulations, as well as the risk that regulatory approval may not be granted on the terms anticipated by the Company or that obtaining regulatory approval may take longer than expected.」
The risks related to regulations and the regulatory framework for pharmaceuticals, including restrictions on raw-material use, discrepancies between anticipated and approved terms, and prolonged approval processes, have been reconfirmed. - FY2022RestatedAnnual report
「We cannot rule out risks such as previously permitted raw materials suddenly becoming completely unusable due to the enactment or amendment of laws, guidelines or other regulations, as well as the risk that regulatory approval may not be granted on the terms anticipated by the Company or that obtaining regulatory approval may take longer than expected.」
The risks of restrictions on raw-material use resulting from regulatory amendments, discrepancies between anticipated and approved terms, and prolonged approval processes have been reconfirmed. - FY2020First statedAnnual report
「We cannot rule out risks such as previously permitted raw materials suddenly becoming completely unusable due to the enactment or amendment of laws, guidelines or other regulations, as well as the risk that regulatory approval may not be granted on the terms anticipated by the Company or that obtaining regulatory approval may take longer than expected.」
New risks related to regulations and the regulatory framework for pharmaceuticals have been disclosed, including restrictions on the use of raw materials, discrepancies between anticipated and approved terms, and prolonged approval processes.