Toward the Establishment of a Supply-Chain System to Secure a Stable Domestic Supply of Antibacterial Drugs
Antibacterial substances (hereafter, antibacterial drugs), especially β-lactam antibacterial drugs including cephem antibiotics*1 focused in this supply securing plan, are not only used for the treatment of infectious diseases, but for the prevention of infection associated with surgical operations. as a recommended drug in clinical guidelines. Meaning, it has extremely high medical need. Nevertheless, almost 100% of its raw materials are dependent on imports from overseas, and has been pointed out as a risk that affects the stable supply of antibacterial drugs to clinical practice in Japan. In fact, a long-term supply shortage happened about cefazolin sodium, which is widely used as a β-lactam antibacterial drug, in 2019 due to manufacturing problems in China, which accounts for the largest proportion of its suppliers. And it occurred that had a serious impact on the medical care service in Japan. Considering these supply chain issues, antibacterial drugs have been designated as "specified important materials" based on the provisions of Article 7 of the Act on Economic Security Promotion Bill, and considerations are underway, led by MHLW, to secure a stable supply of antibacterial drugs for domestic use.
*1 A general term for antibiotics with a β-lactam ring in the molecule, classified into penicillins, cephems, carbapenems, etc.
[Summary of certification of supply securing plan]
Authorized business |
Shionogi Pharma Co., Ltd., Pharmira Co., Ltd. |
Specified Important Materials |
Cefazolin sodium, Cefmetazole sodium |
Initiatives |
Introduce manufacturing equipment for active pharmaceutical ingredients, etc., and develop a stockpiling system |
Certification date |
July 28, 2023 |
References (Only Japanese)
1. Effort Policy for Securing Stable Supply of Antimicrobial Substance Preparations
https://www.mhlw.go.jp/content/001039660.pdf
2. Pharmaceutical Stable Supply Support Project Public Recruitment for Implementing Operators (First Public Recruitment)
https://www.mhlw.go.jp/stf/newpage_12086.html
3. Pharmaceutical Stable Supply Support Project Public Recruitment for Implementing Operators (Second Public Recruitment)
https://www.mhlw.go.jp/stf/newpage_17823.html
4. Pharmaceutical Stable Supply Support Project Public Recruitment for Implementing Operators (Third Public Recruitment)
https://www.mhlw.go.jp/stf/newpage_25875.html
■ About Shionogi Pharma Co., Ltd.
■ About Pharmira Co., Ltd.
For Further Information, Contact:
SHIONOGI Website Inquiry Form : https://www.shionogi.com/global/en/contact.html