Drug safety is a central pillar of the company’s commitment to public health and is integrated throughout the entire pharmaceutical lifecycle from research and development to post-marketing surveillance.
The safety assurance process begins with preclinical studies, where toxicity and pharmacological effects are evaluated in animal models, followed by a structured sequence of clinical trials designed to assess efficacy and safety in both healthy volunteers and patients.
Following regulatory approval, pharmacovigilance systems are employed to continuously monitor and manage any adverse events associated with the marketed drug. Adherence to international regulatory frameworks, including those established by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), ensures that drug development and manufacturing comply with rigorous safety, quality, and environmental standards.
The implementation of Good Manufacturing Practices (GMP) under Quality Management Systems ensures precision in production, cleanliness of facilities, and the integrity of raw materials. Stability testing further supports drug safety by determining appropriate storage conditions and shelf life.
Complementing these practices are comprehensive training programs, meticulous documentation, and systematic reviews of both clinical and non-clinical data. The company also leverages artificial intelligence to enhance safety signal detection and predict potential risks.
In the event of safety concerns, prompt corrective actions such as product recalls, updates to labeling, or issuing new safety warnings are initiated.
Collectively, these measures underscore the company’s proactive and science-based approach to safeguarding public health, maintaining regulatory compliance, and fostering long-term trust among healthcare providers and patients.
Drug Safety is the official journal of the International Society of Pharmacovigilance.
To get more than just information:
Show more »