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China rejects 11 drug applications over inadequate trial data

China rejects 11 drug applications over inadequate trial data

China has signalled a tougher stance on drug quality in the country’s sprawling pharmaceuticals industry by rejecting applications for 11 medicines with inadequate or suspect clinical data.

The China Food and Drug Administration (CFDA) said in statement posted on its website on Nov. 11 that the move affected eight Chinese companies making generic drugs for heart problems, schizophrenia, pain, infections and other diseases.

The crackdown follows a call in July for manufacturers to carry out their own internal investigations into trial data, which had already led to a number of voluntary recalls.

The CFDA then carried out a series of on-site inspections between Oct. 26 and Oct. 31 and discovered that clinical trial data in applications from eight companies for 11 drug products were incorrect or incomplete.

“We have decided to withhold approval from these applications,” the regulator said.

The quality of medicines produced in China is a growing focus both for Beijing, which is pushing an ambitious programme of healthcare reform, and for foreign countries that rely on China and India for pharmaceutical ingredients and finished drugs.

India’s long-established generic drugs industry has run into a series of high-profile quality problems with the U.S. Food and Drug Administration in recent years.

“The CFDA seems very, very determined on this quality issue and that could change the Chinese pharmaceutical industry in a big way,” said one senior executive with a multinational drugmaker.

Deutsche Bank analyst Jack Hu said that the CFDA’s action was a short-term setback for the Chinese industry but should be of long-term benefit to companies with high quality standards, such as Sino Biopharmaceutical, Shanghai Fosun and 3SBio.

The eight companies to have drugs rejected were named by the CFDA as Hainan Pharmaceutical, Zhejiang Huahai Pharmaceutical , Hebei Pharmaceutical, Qingdao Bai Yang Pharmaceutical, Zhejiang Angli Kang Pharmaceutical, Hainan Kang Chi Pharmaceutical, Guangdong Pharmaceutical and Shandong Da Yinhai.

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    Source: Reuters

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