Risk of Changes in Laws and Regulations, Regulatory Approvals, and Drug Prices
First written in FY2017. 3 of 4 entries say "Restated". Latest entry: FY2023.
The whole theme swung hardest in 2018: 20 of 65 companies on the "Worse" side.
47 other companies' latest entry also says "Restated".
- FY2023RestatedAnnual report
「The Group cannot rule out risks such as raw materials whose use has previously been permitted suddenly becoming completely unusable as a result of additions to or revisions of laws, guidelines and other requirements, or regulatory approval not being granted on the terms anticipated by the Group, or taking longer than anticipated to obtain regulatory approval.」
Risks relating to laws and regulations, raw materials, and the terms and timing of regulatory approval continue to be disclosed. - FY2020RestatedAnnual report
「The Group cannot rule out risks such as raw materials whose use has previously been permitted suddenly becoming completely unusable as a result of additions to or revisions of laws, guidelines and other requirements, or regulatory approval not being granted on the terms anticipated by the Group, or taking longer than anticipated to obtain regulatory approval.」
The risk that laws and regulations, the terms or timing of regulatory approval, and drug prices or reimbursement prices may differ from expectations has been reaffirmed. - FY2019RestatedAnnual report
「The Group cannot rule out risks such as raw materials whose use has previously been permitted suddenly becoming completely unusable as a result of additions to or revisions of laws, guidelines and other requirements, or regulatory approval not being granted on the terms anticipated by the Group, or taking longer than anticipated to obtain regulatory approval. In addition, amid global efforts to contain healthcare costs, drug prices and reimbursement prices could be lower than the product value anticipated by the Company.」
Risks relating to laws and regulations, the terms and timing of regulatory approval, and drug prices and reimbursement prices continue to be disclosed as potentially differing from expectations. - FY2017First statedAnnual report
「The Group cannot rule out risks such as raw materials whose use has previously been permitted suddenly becoming completely unusable as a result of additions to or revisions of laws, guidelines and other requirements, or regulatory approval not being granted on the terms anticipated by the Group, or taking longer than anticipated to obtain regulatory approval. In addition, amid global efforts to contain healthcare costs, drug prices and reimbursement prices could be lower than the product value anticipated by the Company.」
The risks identified include changes to laws, regulations and guidelines, the possibility that the terms or timing of regulatory approval may differ from expectations, and the possibility that drug prices or reimbursement prices may differ from expectations.