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

Manufacturing and selling pharmaceuticals and medical products in China is subject to numerous laws and regulations. These regulations are designed to ensure the safety and quality of the medicines and devices produced in China, as well as the protection of consumers. In China, the Ministry of Industry and Information Technology is responsible for drafting and implementing regulations related to drug and medical product production. This includes the “Provisions on the Administration of Drug Production” and the “Regulations on the Administration of Medical Device Production”. These documents specify requirements on pharmaceutical production, quality control, drug registration, advertising, and record-keeping, among other aspects. In addition, the China Food and Drug Administration is responsible for ensuring that all drugs and medical products on the Chinese market are safe and effective. They also oversee the approval of drugs and medical products, as well as supervising the marketing and use of these products. Furthermore, the National Medical Products Administration is responsible for setting standards for the quality of drugs and medical products produced in China and for the monitoring of the products throughout their lifecycle. This includes tracking and providing feedback on drug efficacy and safety, as well as overseeing the approval process for drug clinical trials. Overall, regulations related to the manufacture and sale of pharmaceuticals and medical products in China are comprehensive and designed to ensure that products produced in the country are safe and effective for consumers.

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

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