China Passes Comprehensive New Drug Administrative Law

China has passed a broad Amendment to its Drug Administrative Law, codifying the far-reaching changes to the country's drug approval/administration rules made over the last four years while also significantly increasing punishments for infractions. The new regulations affect almost every part of the biopharma industry. For example, the very successful Marketing Administration Holder rules, which allow a company to outsource manufacturing of its products, will be expanded to all of China from the test provinces. In addition, new regulations to protect China's population from counterfeit or substandard vaccines will carry financial punishments of 10 to 50 times their value, much higher than previous punitive fines. More details....

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