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Drug Quality & Safety Management

Drug Quality & Safety Management

Senhwa Biosciences has established a stable, safe, and high-quality pharmaceutical production and multinational supply chain. From upstream raw material suppliers and outsourced manufacturing to laboratories, clinical trial centers, and other partners, the company has a comprehensive pharmaceutical traceability system and recall mechanism. This allows complete control over the flow and usage records of medications, ensuring timely supply of high-quality, safe drugs for patients. At the same time, the drugs comply with domestic and international regulations and production audits. The company follows regulatory updates, establishes SOPs according to quality systems, and conducts on-site audits of suppliers to ensure compliance with relevant GXP standards.

2024 Execution Results

Strengthening the R&D Team

This year, two new professionals with expertise in new drug formulations (including complex formulations) and generic drug production and registration have been recruited to strengthen the team.

Ensuring Medication Safety

For clinical medications, each batch has a complete stability plan to ensure the safety and efficacy of the drugs.

Clinical Execution Quality

This year, dedicated personnel were trained to manage Safety Management. In apition, two employees completed the Drug Safety eLearning Program from the Drug Information Association (DIA).

In the clinical trial design, non-clinical data related to pharmacokinetics, pharmacodynamics, and safety are integrated to support risk assessments for human trials, along with a dose escalation plan to ensure the optimal dose.

Responsible Safety Risk Assessment

In accordance with ICH and FDA regulations, the company will prepare a Development Safety Update Report (DSUR) based on the year’s safety data, summarizing the efficacy and safety of each clinical trial. This report integrates the data from completed and ongoing trials and evaluates the efficacy and safety outcomes from the past year. The process involves review by department heads, including regulatory, pharmaceutical, preclinical, clinical, and medical affairs departments, followed by a comprehensive risk-benefit assessment before submission to the FDA.

Research and Development of New Dosage Forms

To thoroughly explore novel drug mechanisms, the company invests in the research and development of dosage forms for clinical trials and future market release. QTPP (Quality Target Product Profile) serves as the basis for product lifecycle planning, adhering to ICH, US FDA, TFDA, and other guidelines.

Preclinical Trials

Since the ultimate goal of the drugs is for human treatment, the team invests manpower and resources in conducting multiple tests, including pharmacokinetics (PK), pharmacodynamics (PD), and drug toxicity tests, ensuring preliminary safety and efficacy data before human clinical trials.

Safety Monitoring & Emergency Plans

For ongoing clinical trials, whether sponsored by Senhwa or Investigator Initiated Trials (IIT), a safety management plan has been established or relevant regulations have been drafted according to the contract. Each trial team provides regular adverse event reports, including a list of serious adverse events, for timely safety and risk-benefit assessments by the Chief Medical Officer (CMO) and Safety Specialists within Senhwa.

According to FDA and TFDA regulations, if a new safety finding presents significant risks to the study participants, researchers and regulatory authorities must be immediately notified, and the Investigator’s Brochure (IB) and/or Study Protocol may need to be updated. This year, no clinical trial drug required expedited safety reporting, nor were there any new safety findings that posed significant risks to participants.