Risks from pharmaceutical regulations and revocation of licenses and approvals
First written in FY2016. 2 of 4 entries say "Restated". Latest entry: FY2025.
Daito Pharmaceutical moved to the "Worse" side of this theme in 2025, 3 years after the typical company in this theme (2022).
The whole theme swung hardest in 2021: 2 of 14 companies on the "Worse" side.
1 other company's latest entry also says "Worsened".
- FY2025WorsenedAnnual report
「Ensuring quality and safety and strengthening the stable supply structure following partial amendments to the Pharmaceuticals and Medical Devices Act, including the establishment of a fund to strengthen the manufacturing base for generic drugs」
In addition to the existing risks of revocation of licenses and approvals and tighter regulation, the text identifies new compliance requirements associated with amendments to the Pharmaceuticals and Medical Devices Act and the strengthening of quality, safety, and the stable supply structure as challenges. - FY2018RestatedAnnual report
「The Group endeavors to satisfy the various conditions required to obtain these licenses and approvals and to comply with relevant laws and regulations, and as of the present time no grounds for revocation of these licenses and approvals have arisen. However, if these licenses and approvals are revoked due to violations of laws and regulations or other reasons, this could materially affect the Group's business activities.」
The text continues to describe the possibility of revocation of licenses and approvals and explains that no grounds for revocation had arisen as of the filing date. - FY2017RestatedAnnual report
「The Group endeavors to satisfy the various conditions required to obtain these licenses and approvals and to comply with relevant laws and regulations, and as of the present time no grounds for revocation of these licenses and approvals have arisen. However, if these licenses and approvals are revoked due to violations of laws and regulations or other reasons, this could materially affect the Group's business activities.」
While describing the possibility of revocation of licenses and approvals, the text explains that no grounds for revocation had arisen as of the filing date. - FY2016First statedAnnual report
「If these licenses and approvals are revoked due to violations of laws and regulations or other reasons, this could materially affect the Group's business activities.」
The text also cites business constraints resulting from tighter regulations, including the Pharmaceutical Affairs Law and GMP-related laws and regulations, as well as new regulations.