The General Office of the State Council recently issued “Opinions on Comprehensively Deepening Pharmaceutical and Medical Device Regulatory Reform to Promote High-Quality Development of the Pharmaceutical Industry”. Optimize import approval for pharmaceuticals and medical devices. Streamline the review and approval of traditional oral proprietary Chinese medicines already marketed in Hong Kong and Macau. Optimize the management of imported medicinal herbs and expand the import of high-quality herbal medicine resources from abroad. Drugs that have already been marketed abroad are allowed to import and sell pre-approved commercial-scale batch products that meet the requirements after obtaining China's drug approval certificate. Optimize the review and approval process for transferring overseas pharmaceuticals and medical devices that have already been marketed domestically to domestic production, and support foreign-invested enterprises to introduce original pharmaceuticals and high-end medical equipment into domestic production.
国办:境外已上市药品在取得我国药品批准证明文件后 对符合要求的获批前商业规模批次产品允许进口销售
State Office: Drugs already marketed abroad are allowed to import and sell pre-approved commercial-scale batch products that meet the requirements after obtaining China's drug approval certificate
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