Effective on September 29, 2025, Chinese Regulatory Authorities allow the import of commercial-scale batches of drugs that are already marketed abroad and produced prior to receiving approval in China, provided they meet pre-approval requirements and successfully pass GMP inspections.
The regulation applies to six categories of drugs, including innovative therapies and treatments for rare diseases, and extends to post-marketing changes. Risk management responsibilities are shared between foreign marketing authorization holders (MAHs) and domestic responsible parties, while streamlined authentication procedures are introduced to facilitate compliance.