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Review: Progress of Acceptance Work of Generic Drug Consistency Evaluation in 2017 Erxiao
January 05, 2018
Varieties to be completed the generic drug consistency evaluation be the end of 2018...
CFDA accepts Eisai's NDA for cancer drug biospectrumasia
November 01, 2017
Eisai submitted applications for an additional indication for lenvatinib for the treatment of HCC in Japan (June 2017), the United States and Europe (July 2017).
The first recombinant Ebola virus vaccine was approved by CFDA en-cphi.cn
October 20, 2017
October 19, 2017, the State Food and Drug Administration approved the "recombinant Ebola virus vaccine (adenovirus vector)" new drug registration application.
CFDA approves Gilead’s Sovaldi for chronic hepatitis C treatment pharmaceufical-technology
September 27, 2017
The China Food and Drug Administration (CFDA) has approved Gilead Sciences’ Sovaldi (sofosbuvir at 400mg) for the treatment of patients with chronic hepatitis C virus (HCV) infection.
When Will Chinese “Rituxan” be Marketed in Compete with More Than a Dozen Applying for anti-CD20 en-cphi.cn
July 14, 2017
CFDA released the 2016 Annual Report of Release of Biological Products written by the National Institutes for Food and Drug Control of China on July 4, which has made statistics of biological products included in release management.
Embarrassing Two Different Worlds in Consistency Evaluation: Some about to Win, in the Wrong Track en-cphi.cn
July 07, 2017
With a half of 2017 past, it is only about one and a half year from the time limit for the consistency evaluation of the 289 generic drug varieties in 2018.
What revolutionary changes the new draft for comment of CFDA on clinical trials will bring? en-cphi.cn
June 02, 2017
CFDA issued the Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Reforming the Administration of Clinical Trials (Draft for Comment) at midnight of May 11 to solicit comments from the society.
TaiGen Biotechnology announces the submission of NDA for Taigexyn to the CFDA biospectrumasia
June 02, 2017
Taigexyn is a novel broad spectrum antibiotic with excellent efficacy against drug-resistant bacteria available in both oral and intravenous formulations. The oral formulation is already approved for marketing and launched in Taiwan, China and mainland Ch
Athenex and Its Partner, Guangzhou Xiangxue Pharmaceutical, Announced Chinese FDA IND Approval to Be en-cphi.cn
May 25, 2017
Athenex, Inc., Buffalo, NY announced Guangzhou Xiangxue Pharmaceutical Co. Ltd., (Xiangxue) has received the Chinese FDA Investigational New Drug (IND) approval to begin clinical trials for...
CFDA consecutively issued new policies to lift controls over medical device and clinical trials en-cphi.cn
May 18, 2017
China Food and Drug Administration (CFDA) consecutively issued four reform policies (drafts for comment) on May 11 to solicit public opinions from the society.

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