China’s Order 818—Regulations on the Administration of Clinical Research and Clinical Translation and Application of Biomedical New Technologies—establishes a new commercialization pathway for cell and gene therapeutics, gene editing, and other advanced therapeutics. More importantly, it signals China’s intent to accelerate local innovation and standardize the drug development environment, thereby becoming a more important player in advanced therapy development and manufacturing.
Order 818 allows therapeutics whose mechanisms of action are at the cellular or molecular level to be clinically translated at 3A hospitals without requiring National Medical Products Administration (NMPA) drug registration. Once translational approval is granted, hospitals may begin charging patients for these treatments. While the move appears to be viewed positively by the biopharma industry, some details are still being ironed out. For example, boundary delineation guidelines still need to be issued to specify which technologies fall under Order 818 and which remain under the NMPA’s purview.
For international firms partnering with Chinese companies to develop advanced therapeutics, the new regulatory pathway triggers a review of existing contracts and milestone clauses. The greatest disruption may be for Chinese companies that are in the midst of investigator-initiated trials for advanced therapies at smaller institutions. This affects contract research and manufacturing organizations, too, who are producing materials for such trials. Therefore, to succeed under this dual-pathway system, multinational corporations must redefine success based on clinical and commercial outcomes rather than solely on regulatory pathways.
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