Shofu (7979) · RiskRestated
Continuation of Licenses and Registration under the Pharmaceuticals and Medical Devices Act
First written in FY2016. 1 of 2 entries say "Restated". Latest entry: FY2018.
2entries
3years
0from disclosures
How it moved
Same theme, other companies
Medical Device Regulatory and Licensing ComplianceA theme 16 companies write about · 16 as a headwind · 0 as a tailwind
The whole theme swung hardest in 2018: 1 of 7 companies on the "Worse" side.
7 other companies' latest entry also says "Restated".
Ridges = years it wrote progress, valleys = years it wrote worse. Most hopeful companies at the back. Drag to turn, scroll to zoom, right-drag to pan. On a phone, two fingers turn and pinch to zoom; one finger scrolls the page.
Showing 14 of the 16 companies compared. The sentences above are computed from all 16.Full recordFilings, disclosures and news, newest first
- FY2018RestatedAnnual report
「The validity periods of the relevant licenses and registration are 5 years for the manufacturing and marketing license, 6 years for the marketing license and 5 years for the manufacturing registration. Although these licenses could be revoked if the statutory requirements are no longer satisfied, no factor currently exists that would impede their continuation.」
The Company has reiterated the risk of revocation of the licenses and registration and their validity periods of 5 years for manufacturing and marketing, 6 years for marketing and 5 years for manufacturing. It states that no factor currently exists that would impede their continuation. - FY2016First statedAnnual report
「If these licenses or other approvals were revoked for any reason, this could adversely affect the continuation of the Group's business.」
Maintaining the 5-year manufacturing and marketing license, 6-year marketing license and 5-year manufacturing registration, as well as satisfying statutory requirements, are identified as important issues for business continuity.