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Alert: China Issues New Policy for Drug and Medical Device Approvals

On October 8, 2017, the General Office of the CPC Central Committee and the General Office of China's State Council jointly issued Opinions of the State Council on Promulgating the Reform of Review and Approval System for...more

Alert: China’s Government Issues Foreign Investment Industry Guidance Catalogue (2017 Version)

On June 28, 2017, the National Development and Reform Commission (NDRC) and the Ministry of Commerce (MOFCOM) of the People's Republic of China (PRC) jointly issued the Foreign Investment Industry Guidance Catalogue (2017...more

7/28/2017  /  China , Foreign Investment , MOFCOM , NDRC , PRC

Alert: US Issues Temporary License for Exports to Chinese Telecom Company ZTE

Today, March 24, 2016, the US Commerce Department's Bureau of Industry and Security ("BIS") issued a final rule revising the Export Administration Regulations ("EAR") and creating a temporary general license lifting certain...more

Alert: US Restricts Exports and Reexports to Chinese Telecom Company ZTE

The US Commerce Department's Bureau of Industry and Security ("BIS") has issued a final rule amending the Export Administration Regulations ("EAR") and imposing trade restrictions against Zhongxing Telecommunications...more

Alert: China Food and Drug Administration Offers Guidance on Clinical Trial Exemptions for Medical Devices

The "Administrative Measures for the Registration of Medical Device" (Registration Measures) was issued by the China Food and Drug Administration (CFDA) and became effective on October 1, 2014. According to the Registration...more

Alert: China Piloting Drug Marketing Authorization Holder System

The Chinese central government has taken several important steps in reforming the drug approval system in China, which could have far-reaching implications for pharmaceutical companies in China as well as foreign companies...more

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