China’s NMPA has implemented a new regulatory framework governing the manufacture, inspection and certification of pharmaceuticals intended for export. The Regulations require export manufacturers to maintain comprehensive export drug dossiers, comply with GMP requirements, and ensure that product specifications, labelling and quality standards meet the requirements of the importing jurisdiction.
Regulations also introduce detailed rules for contract manufacturing arrangements and establish updated procedures for obtaining export certificates for pharmaceutical products and APIs. In addition, the framework strengthens risk-based supervision, including inspections of manufacturing, storage and transportation activities, and provides for certificate invalidation and other enforcement measures in cases of non-compliance. The Regulations replace several earlier export-related measures and consolidate China’s approach to supporting pharmaceutical exports while reinforcing regulatory oversight and product quality standards.