Directive against 医薬品医療機器総合機構
Action summary
- Company
- 医薬品医療機器総合機構Japanese onlyOriginal: 医薬品医療機器総合機構Corporate Number: 3010005007409
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- Directive指示
- Action date
- September 1, 2015
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Although no additional safety measures were taken based on unreported adverse effect information, to prevent recurrence, the Ministry of Health, Labour and Welfare has instructed companies with unreported adverse effect information to report the causes and corrective measures regarding these reporting delays to the Pharmaceuticals and Medical Devices Agency, aiming to ensure proper adverse effect reporting by each company.
Show original Japanese text
未報告の副作用情報に基づく追加の安全対策を講ずるものではありませんでしたが、再発防止のため、厚生労働省は、未報告の副作用情報が見つかった企業に対し、これらの報告遅延に関して、原因及び改善方策を（独）医薬品医療機器総合機構へ報告させ各社における適切な副作用報告の徹底を図ります
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
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Language
日本語版を見る (Japanese)Company info
- English name
- 医薬品医療機器総合機構 Japanese only
- Japanese name
- 医薬品医療機器総合機構
- Corporate Number
- 3010005007409
- Registered address
- 東京都千代田区霞が関３丁目３番２号
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.