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Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Japanese pharmaceutical and regulatory environment
Ryoichi Nagata1, Jean-David Rafizadeh-Kabe
1CEO and Chairman, SNBL Ltd, Kagoshima, Japan (Ryoichi Nagata); Medical Advisor, SNBL Ltd, Baltimore, Md, USA (Jean-David Rafizadeh-Kabe).
Abstract:
Drastic regulatory changes in Japan since 1997 have had a considerable impact on the way new medicines are developed. The regulatory authority itself has been transformed. Clinical trials are now performed according to international guidelines. Clinical data generated in one area are acceptable in the rest of the world in some cases through a bridging process that is viewed as only temporary. The future of drug development lies in multinational clinical trials and simultaneous submission to the major regulatory authorities.
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Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

