China is actively reshaping its regulatory landscape to promote local pharmaceutical manufacturing, offering new pathways for foreign companies to produce and commercialize drugs within the country. Recent changes to the Drug Administration Law and the implementation of the Market Authorization Holder (MAH) system are designed to streamline drug approvals, improve market access, and boost foreign investment in the life science sector.
Easing the Transition to Local Production
A key development is the NMPA No. 49 Regulation, issued in April 2023, which provides guidance for the local manufacturing of drugs already approved in China as "imported drugs." This regulation allows foreign pharmaceutical companies to transfer production to domestic Chinese entities, enabling them to leverage local manufacturing capabilities and reduce costs.
The regulation stipulates that the application for drug marketing authorization must be submitted by a "domestic applicant," who will then serve as the MAH and be responsible for the product's safety and quality control throughout its lifecycle. The locally manufactured drug will be approved following the registration path for generic drugs, ensuring consistency with existing standards.
Consistency and Priority Review
The Center of Drug Evaluation (CDE) emphasizes the consistency of the manufacturing process, prescription composition, raw materials control, and packaging materials. Any differences from the original Biologics License Applications (BLAs) or New Drug Applications (NDAs) of the imported counterpart must be supported by supplementary research.
Notably, applications for local manufacturing of originator chemical drugs and biologics are eligible for priority review and approval by the NMPA. This can shorten the review and approval timeline to approximately 130 days, compared to the standard 200 days. CDE published its decision to apply the prioritized review and approval procedure Zevtera (ceftobiprole medocaril sodium) per application of Shenzhen China Resources Gosun Pharmaceutical Co. Ltd. (CR Gosun), making reference to this new regulation as the legal basis, underlines the government’s support to innovative drugs.
Challenges and Considerations
Despite these advancements, challenges remain. Intellectual property (IP) protection during technology transfer is a significant concern for foreign MAHs. Other issues include regulatory compliance during the transfer of market authorization, balancing economic feasibility with quality assurance, and navigating local policies for originator and generic drugs in public procurement.
While the NMPA No. 49 Regulation does not fundamentally alter the existing drug manufacturing framework, it offers a new option for foreign companies to commercialize drugs in China without disrupting the established regulatory regime. However, careful consideration of IP rights, regulatory compliance, and local market dynamics is crucial for successful implementation.
