On January 27, the newly revised "Implementation Regulations of the Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Regulations") was officially promulgated and will come into effect on May 15. As the first comprehensive revision of regulations in 23 years, the new "Regulations" signify that China's drug regulatory perspective has expanded from solely focusing on "physical factories" to covering the "full life cycle" of pharmaceuticals. This revision represents a significant breakthrough in regulatory thinking, with core changes concentrated in the following key dimensions:

● Removal of restrictions on "segmented production" models: Allowing Marketing Authorization Holders (MAHs) to delegate different production stages to multiple enterprises, provided that a "unified quality assurance system" is established

● Implementation of a 5-year validity system for API approval certificates: Certificates will not be re-registered if they expire without renewal or fail post-marketing evaluation

● Strengthening MAH accountability: Regulatory focus shifts to MAHs, with stricter assessment requirements for API suppliers

● Emphasis on authenticity of procurement and production records: Requiring "paper traceability" for each batch of APIs to ensure traceability.

It is evident that APIs are no longer merely chemical products but core components closely integrated with formulations. The implementation of the new "Regulations" not only demonstrates the Chinese drug regulatory authorities' firm commitment to upholding the "quality red line" but also highlights the core significance of full life cycle management of pharmaceuticals: every stage from API production to end-use must be strictly controlled. In the face of a new regulatory landscape, pharmaceutical companies urgently need to adjust their supply chain structures by establishing diversified and high-standard raw material supply systems, enhancing compliance management capabilities and risk resistance, to better adapt to the increasingly stringent regulatory trends in drug development.