China raises threshold for drug certification

BEIJING—In the wake of several drug production scandals the Chinese government has tightened up application procedures for firms seeking to manufacture drugs.
The threshold to qualify for a Good Manufacturing Practice (GMP) certification has been raised and will come into effect on January 1 next year.
“The new standards are stricter in granting GMP certificates to drug manufacturers,” said Bian Zhenjia, director with the drug safety supervision department under the State Food and Drug Administration (SFDA), China’s drug watchdog. Before revision, if less than three “severe defects” as defined in the standards were discovered in the entire drug making process, the manufacturers could still get a certificate if they corrected the problem within a prescribed time limit.The new standards, however, allow no “severe defects” according to Bian.
“The new standards have strengthened supervision over weak links in quality control of drug manufacturers,” Bian said.
The revised standards comprise 259 articles, an increase of 34 articles from the current standards which were put into effect in 1999.
And the “key” articles have been augmented from previous 56 to 92, according to Bian.
“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 explained.
The new standards also stipulate that companies falsifying application documents shall be regarded as having a “severe defect,” meaning they will fail the GMP certification.—Xinhua