JRQ regenerative medicine quality standard development

The Japan Regenerative Medicine Quality Standards Council (JRQ) has issued a series of white papers to establish standardized quality management and information transparency within the regenerative medicine and health food sectors.

Initial guidance focused on information disclosure and conformity verification. These papers outlined methods for distinguishing public-facing documents from internal records, maintaining consistent revision histories, and separating application summaries from actual verification records to ensure accountability and traceable links between processing, testing, and storage.

Subsequent guidance expanded into risk management and corrective action protocols. The council provided frameworks for managing deviations, emphasizing the need to separate the identification of impact scope from the suspension of use and fact-finding roles. Additionally, new standards addressed the verification of completed corrective actions, requiring organizations to maintain distinct documentation for deadlines, implementation evidence, and long-term evaluations to prevent recurrence.