Thread Content
This post was last edited by If so_LVSjD on 2026-2-4 at 11:52. On January 16, 2026, Li Qiang, Premier of the State Council, issued Order No. 828 of the State Council, announcing the revised Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China (hereinafter referred to as the \"Regulations\"), which came into effect on May 15, 2026. This is the first comprehensive revision in 23 years since the implementation of this regulation, with over 90% of the provisions being amended. The key revisions include improving the drug development and registration system, strengthening production management, standardizing operation and use, as well as enforcing strict safety oversight. Regarding the drug production phase, the Regulations explicitly permit phased outsourcing of production, which is applicable to situations such as innovative drugs with special requirements regarding production processes or facilities and equipment, drugs urgently needed for clinical use, drugs urgently required in case of public health emergencies, or drugs intended for stockpiling. The marketing authorization holder must establish a unified quality assurance system that covers the entire process and all production sites, to ensure that production remains in compliance with legal requirements. This provides a flexible mechanism for the production of drugs involving complex manufacturing processes, while imposing higher compliance standards regarding equipment corrosion resistance, cleaning validation, and prevention of cross-contamination. Equipment compliance challenges in the segmented production model: Traditional drug production typically requires that all manufacturing steps be carried out at a single facility, whereas segmented production allows different stages to be outsourced to specialized companies. This approach is suitable for innovative drugs that require various technologies and special equipment, such as antibody-conjugated drugs and biologics. But this also presents challenges: the equipment must ensure consistency in quality across different stages, prevent the release of harmful ions, and avoid the risk of cross-contamination. Pharmaceutical manufacturing processes often involve highly corrosive substances such as hydrochloric acid, sulfuric acid, chlorides, and organic solvents. Traditional 316L stainless steel is prone to pitting or ion release in such environments, leading to equipment degradation, frequent maintenance needs, and even affecting the purity of drugs and compliance with GMP standards. The new regulations strengthen the responsibilities of holders, with the upgrading of equipment and materials becoming crucial. Advantages of tantalum metal in pharmaceutical equipment: Tantalum (Ta) is a rare metal with a high melting point (2996°C) and excellent corrosion resistance. The dense Ta₂O₅ oxide layer that forms on its surface is nearly inert in most inorganic acids (except hydrofluoric acid), resulting in an extremely low corrosion rate