BEIJING, Nov. 21, 2025– China's National Medical Products Administration (NMPA) has officially released the "Regulations on the Inspection and Export Certification of Drugs by Manufacturers," marking a significant step to standardize and enhance the management of pharmaceutical exports.

The new regulation, effective from January 1, 2026, establishes a comprehensive framework for drug manufacturers. It mandates rigorous internal quality inspections and specific documentation requirements before drugs can be shipped abroad. A central provision is the formalization of the "Export Drug Certificate," which serves as an official government endorsement attesting that the products meet quality standards.

Authorities state that these measures are designed to solidify the responsibility of manufacturers, ensuring that all exported medicines comply with both Chinese regulations and the requirements of the importing countries. This move aims to bolster the international reputation of Chinese pharmaceuticals, facilitate global supply chain integrity, and safeguard public health worldwide. The NMPA emphasizes that this systematic approach underscores China's commitment to its role as a reliable supplier of high-quality medicinal products in the international market.