Drug Quality Management
2023 Important Performance
- The manufacturing site passed the API GMP and finished product GMP and GDP inspections by the Taiwan Food and Drug Administration.
- Oneness Biotech passed the Medical Devices Quality Management Systems (QMS) from the Ministry of Health and Welfare.
- No major violation of laws or regulations regarding of medicinal products.
- No product quality-related events that are required to be reported.
| Quality Policy: Continuous Quality Improvement for Excellence |
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| Objectives of Quality Management |
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Pharmacovigilance
Oneness Biotech has created a “Pharmacovigilance System” according to the Pharmaceutical Affairs Act, the Regulations for the Management of Drug Safety Surveillance, the Regulations for Reporting Serious Adverse Drug Reactions, the Guidelines for Filling Out Forms for Reporting Serious Adverse Drug Reactions, the ICH Guideline E2C (R2) on Periodic Benefit-Risk Evaluation Report (PBRER), and so on. The company established the Post-Marketing Drug Quality Monitoring System, which, due to organizational restructuring in September 2023, is now led and coordinated by the Regulatory Affairs Team under the President’s Office. The Quality Assurance Center, the R&D, sales, clinical, and IT departments collaborate to ensure that the system is in normal operation and that all the necessary documents are prepared, archived, and reported as required. During the reporting period of 2022-2023, no serious adverse drug reactions were reported.
Oneness Biotech collects cases of adverse drug reactions through the monitoring system, has created and maintains a report database, and keeps monitoring the safety of the approved drugs, in order to protect patients’ safety and take on responsibilities for its products and to patients using the products.
Procedure for Post-Marketing Drug Quality Monitoring Reports
Ethical Marketing
Sales activities of medicinal drugs in line with WHO Ethical criteria for medicinal drug promotion
Oneness Biotech has formulated the “Codes of Ethical Conduct” and “Marketing and Sales Code of Conduct”. It is required that marketing and sales personnel must comply with relevant laws and regulations and the recognized ethical standards of the pharmaceutical industry. Marketing documents must be internal reviewed to ensure the content is consistent with the indications and in compliance with regulatory requirements. The Company regularly (quarterly/yearly) organizes education and training to educate relevant personnel to sell medicines properly; and shares share medical information with medical service providers and patients in an open, transparent, and timely manner to avoid information asymmetry. In 2023, there were three customer complaints related to drug sales, of which one was identified as unfounded, and the other two were packaging damage. None of these cases affected the safety and efficacy of the products.
Ethics Audit
Oneness Biotech set up an Audit Office under the Board of Directors as an independent audit unit. The Company conducts Ethics Audit in accordance with the “Marketing and Sales Code of Conduct” and “Codes of Ethical Conduct”, and the internal audit unit regularly reports the inspection results to the Audit Committee and the Board of Directors. Major violation cases should be reported immediately to the members of the Audit Committee and transparently disclosed in the ESG report. There was no violation noted in 2023.
※The above content is taken from the ESG Report
