Governance
Quality, Ethics & Governance
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Quality, Ethics & Governance
We maintain the quality, research ethics, data integrity and governance systems that underpin research, drug discovery and clinical practice.
This page sets out our approach and our arrangements for quality management, research ethics and data management, our Certified Special Committee for Regenerative Medicine, and compliance.
Contents
01
Quality management
03
Certified Special Committee for Regenerative Medicine
02
Research ethics and data integrity
04
Compliance
Contents
01
Quality management
02
Research ethics and data integrity
03
Certified Special Committee for Regenerative Medicine
04
Compliance
Quality Management
We maintain quality management systems for research and manufacturing, and set the control parameters, testing, records and procedures required for the characteristics of each product or technology and the stage it has reached. Operations follow applicable laws, guidelines and standards, together with our internal procedures, so as to support the reliability of both quality and data.
How we approach control
For each new drug candidate we set the quality attributes and control parameters required by its characteristics, its stage of development and the purpose of the study, and we record the scientific basis for those choices and how they were reached. Alongside the assessment of individual elements, we take account of the properties of the whole as a complex system of multiple components and interactions, and place weight on reproducibility, traceability and data integrity.
Standard held
ISO/IEC 17025:2017
Accreditation body
Perry Johnson Laboratory Accreditation, Inc.（PJLA）
Accreditation no.
129309
Scope
Chemical Testing
Period of validity
7 May 2025 – 31 August 2027
Facility
Advalife Science Shin-Yokohama Facility
01
Research Ethics & Data Integrity
Research is carried out in accordance with the laws, ethical guidelines and research protocols that apply to it, and only after the necessary ethical review and other procedures have been completed.
Medical and research data are managed with regard to the purpose of use, access rights, storage and disclosure, with weight placed on the protection of personal information and on data integrity. In evaluating and publishing research results we distinguish between findings and their limits, and avoid arbitrary interpretation or over-generalisation. The handling of personal information is set out in our Privacy Policy.
When publishing research results we distinguish established fact from scientific interpretation and from hypothesis, and state the limits and uncertainties of the findings. For candidates that have not been approved as pharmaceutical products, and in accordance with applicable law, we do not publish material that claims efficacy or effect, or that is intended to encourage purchase or use.
Certified Committee
The Advalife Science Certified Special Committee for Regenerative Medicine is certified by the Minister of Health, Labour and Welfare under the Act on the Safety of Regenerative Medicine. It reviews regenerative medicine provision plans and related matters fairly and rigorously, from medical, scientific, legal and bioethical perspectives.
Name
Advalife Science Certified Special Committee for Regenerative Medicine
Category
Certified Special Committee for Regenerative Medicine
Certification no.
NA8230001
Committee website
Compliance
Research, drug discovery, manufacturing, clinical work and communication are all conducted in accordance with the laws, guidelines and internal rules that apply to the organisation and to each function within the group.
01
The PMD Act
Under the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (the PMD Act), communication about unapproved pharmaceutical products is handled so that it does not constitute advertising claiming efficacy or effect, or material intended to encourage purchase or use.
02
Medical Care Act and medical advertising guidelines
Advertising and websites for the healthcare institutions we operate are managed by each institution in accordance with the Medical Care Act, the medical advertising guidelines and other applicable rules.
03
Personal information and data management
Personal information and research and medical information are managed at every stage — collection, use, storage and disclosure — in accordance with the Act on the Protection of Personal Information, other applicable laws and our internal rules.
04
Conflicts of interest and independence
In joint research, business partnerships, donations and funds and other external relationships, conflicts of interest are managed appropriately, with weight placed on the independence and transparency of research, clinical judgement and committee review.
QUALITY & GOVERNANCE
Enquiries about quality, ethics and governance
We welcome enquiries about quality management, research ethics, the committee and compliance.