Drug safety is a critical issue concerning people's livelihoods, directly impacting public health and safety as well as social harmony and stability. “Quality and safety are the lifeline of pharmaceuticals. Pharmaceutical manufacturers and distributors must genuinely prioritize drug quality and safety, earnestly fulfill their primary corporate responsibilities, strengthen management, eliminate any complacency regarding drug quality and safety, resolutely curb the temptation to sacrifice drug quality and safety for improper gains, and achieve coordinated and healthy corporate development.”

To ensure drug production safety, China has implemented numerous measures in recent years. For instance, the country established Good Manufacturing Practice (GMP) standards long ago, releasing a new version in 2010 that aligns with EU standards. These regulations mandate that enterprises meet national requirements across raw materials, personnel, facilities, production processes, packaging/transportation, and quality control. Additionally, the regulations require that data throughout the production process be complete, authentic, and traceable. Beyond this, the China Food and Drug Administration (CFDA) conducts unannounced inspections at any time, further strengthening oversight of the pharmaceutical industry. From a policy perspective, China has established a set of operational standards to help companies standardize production processes, enabling timely identification and improvement of issues during manufacturing.

In recent years, pharmaceutical safety has garnered significant national attention, yet safety incidents still occur periodically, such as the recent vaccine-related events. So how can we better prevent pharmaceutical safety incidents? Leveraging modern technology to implement “smart regulation” projects holds significant importance. MES systems will make pharmaceutical production smarter. Reportedly, MES enables tracking, monitoring, controlling, and managing production processes. By connecting to the field level, operators can gain real-time visibility into production status. To align with the overall smart pharmaceutical planning requirements, all Milang equipment and systems are equipped with data acquisition modules, ensuring seamless data connectivity with upper-level ERP and MES systems in manufacturing plants. This establishes the foundation for achieving intelligent production. Ensuring drug safety requires a combined approach of technological, institutional, and ethical measures. However, the ultimate solution lies in technological solutions, with smart manufacturing playing a crucial role.

Quality and safety are the lifeline of pharmaceuticals, directly impacting public health. Ensuring the safety of pharmaceutical production is paramount. Yet, pharmaceutical manufacturing demands not only more robust regulatory frameworks but also greater adoption of intelligent automation solutions. These technologies empower pharmaceutical companies to achieve transparency, controllability, and intelligence in their production processes. In this new era of pharmaceutical production, only by adhering to ethical standards and leveraging increasingly automated, intelligent, and informatized technologies can pharmaceutical safety issues be fundamentally resolved. China must strengthen awareness of primary responsibility for drug quality, urge production and operation enterprises to fully fulfill their duties, accelerate the formation of a robust regulatory synergy to safeguard drug quality and safety, eliminate risks with utmost effort, ensure the quality and safety of pharmaceuticals citywide, promote the healthy development of the pharmaceutical industry, and protect public health.