China Strengthening the Efforts to Approve Imported New Drugs
DATE: 2015-01-05

According to the U.S. media, foreign pharmaceutical enterprises in China said that they worried that the latest administrative provisions might have their plan postponed up to 2 years to introduce the latest drugs to China. At least 34 applications from foreign enterprises have been or will be postponed after Chinese regulatory agency claimed to increase one approval procedure.

Bayer estimated that China would approve it to launch one kind of new drug to the market in October 2013, but now this German pharmaceutical enterprise said that the final approval time of China was still undetermined, which may be postponed to the end of 2015 or the beginning of 2016. RDPAC said that it was previously 2 years before China approved new drugs developed via international testing, and now the required time might be twice than before.

China has not publicly explained the reasons for this adjustment, however, according to Lu Xianping, president of Shenzhen Chipscreen Biosciences Ltd., some diseases had possibly different effects on patients in East Asia, therefore, the stricter supervision on the international drug testing might bring benefits.

Originally they (foreign pharmaceutical enterprises) first need to be approved to conduct international clinical test. Then they should submit data for approval and could start to sell pharmaceutical products in China after passing the approval. But according to RDPAC, the second step is now divided into two: they shall first submit data for clinical test approval, and then apply for final approval of sales.