Changes in Medical and Pharmaceutical Regulations Affecting the Health Tech Business
First written in FY2019. 1 of 3 entries say "Restated". Latest entry: FY2021-Q3.
The whole theme swung hardest in 2020: 1 of 8 companies on the "Worse" side.
0 other companies' latest entry also says "Dropped".
- FY2021-Q3DroppedAnnual report
「Because the company sold all of its shares in its former consolidated subsidiary 株式会社フリービットEPARKヘルスケア (now Kusurinomadoguchi,Inc.) in October 2020, the risks relating to the healthtech business described in the previous fiscal year’s Annual Securities Report under “(1) Risks Relating to the Business Environment, ④ Legal Regulations” and “(3) Risks Relating to Business Operations, ① Information Leakage” no longer apply.」
The company states that the medical and pharmaceutical regulatory risks specific to the healthtech business, including risks related to the PMD Act, ceased to exist following the sale of the business. - FY2020RestatedAnnual report
「In the healthtech business, we provide services in adjacent fields that contribute to improving hospital and pharmacy services and increasing system efficiency. Because these services relate to human health, numerous laws and regulations apply, including the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, commonly known as the PMD Act.」
The company continues to disclose medical and pharmaceutical regulatory risks, including risks related to the PMD Act, in its healthtech business. - FY2019First statedAnnual report
「Because these services relate to human health, numerous laws and regulations apply, including the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, commonly known as the PMD Act.」
The company newly disclosed the possibility that changes to or tighter enforcement of laws and regulations, including the PMD Act, could affect the development of its healthtech business.