China is to improve quality of pharmaceutical products after a number of deaths from low-grade medicaments.
The new standard, which takes effect Jan. 1, will tighten rules that currently let a producer obtain a license if three defects are found but corrected, the Xinhua News Agency said.
In future, no "severe defects" in the drug manufacturing process will be allowed, said Xinhua.
"The new standards have strengthened supervision over weak links in quality control of drug manufacturers," the director of the State Food and Drug Administration's drug safety supervision department, Bian Zhenjia, was quoted as saying.
The report said submission of false information by pharmaceutical companies was considered a "severe defect" but gave no examples of other defects cited in the standard.
The government launched an overhaul of drug regulation and licensing this year after a string of deaths and injuries blamed on defective or phony drugs.
A former SFDA director was executed in July on charges that he took bribes to approve untested drugs. In February, the government ordered a review of 170,000 drug production licenses granted during his time in office to see that they were properly granted.
The new rules on "good manufacturing practice" also give additional technical specifications, Xinhua said.
"The changes mainly dwell on technological requirements on management which concerns areas including personnel qualifications, production process, quality control and document verification in a bid to ensure drug quality," Bian was quoted as saying.