What laws and regulations apply to the manufacture and sale of pharmaceuticals and medical products in China?

China has implemented a number of laws and regulations related to the manufacture and sale of pharmaceuticals and medical products. The Guidelines on Supervision and Administration of Medical Products are the main regulations governing the operations of pharmaceutical and medical product manufacturers, suppliers, distributors, and other entities in China. These guidelines are designed to ensure that the quality and safety of the drugs and medical products manufactured and sold in China are maintained to international standards. The State Food and Drug Administration (SFDA) is responsible for implementing the Guidelines. Manufacturers, suppliers, distributors, and other entities involved in the manufacture and sale of pharmaceuticals and medical products in China must comply with the standards set out in the Guidelines and adhere to the SFDA’s regulatory requirements. All manufacturers, suppliers, and distributors of medical products must obtain an SFDA Pharmaceutical Manufacturing License before they can manufacture or sell medical products in China. The SFDA conducts regular inspections of manufacturers, suppliers, and distributors to ensure that they comply with the Guidelines. Manufacturers and distributors of pharmaceuticals and medical products must also register each drug with the SFDA before it can be sold in the country. Manufacturers and distributors of medical products must also bear the responsibility for ensuring that their drugs and medical products are safe and effective.

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What laws and regulations apply to the manufacture and sale of pharmaceuticals and medical products in China?

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