China toughens drug quality standards, rejects 13 applications
BEIJING – China’s food and drug regulator said late on Monday it had rejected applications for 13 new drugs, citing false or incomplete trial data, as the government toughens enforcement of quality standards.
The China Food and Drug Administration (CFDA) last month also rejected applications by eight Chinese companies for inadequate trial data related to generic drugs for heart problems, schizophrenia, pain, infections and other diseases.
The quality of locally made drugs is a priority for the government, which is pushing an ambitious program of healthcare reforms to reduce reliance on both generic and more innovative imported drugs.
The regulator’s crackdown comes after it called on manufacturers to carry out their own internal investigations into trial data in July, a move expected to raise the quality of local drugs over the long-run, creating a challenge for global pharmaceutical firms.
The top 10 Chinese drugmakers have seen sales grow around 12 percent this year, according to data from IMS Consulting, twice the rate of multinationals, which suffered a setback from a bribery scandal at GlaxoSmithKline two years ago. –Reuters