On March 17, 2018, China’s National People’s Congress (NPC) approved a general plan proposed by China’s State Council to restructure certain Chinese government agencies. This restructuring plan affects a wide range of Chinese...more
Over the past weekend, the Chinese legislature decided on a major restructuring of governmental agencies. The restructuring plan was announced by the State Council on 13 March 2018, and approved by the National People's...more
Historically, the US, and, in particular, the NASDAQ market, has been the predominant place for IPOs of life sciences and healthcare companies. However, 2018 may be the year in which things start to change....more
The new catalogue, which becomes effective on August 1, 2018, is likely to have a significant impact on the registration, manufacturing, operation, and distribution of medical devices in China. ...more
On 12 May 2017, the Chinese Food and Drug Administration (the “CFDA”) issued several draft policies aimed at overhauling of the current regulations governing the Chinese pharma and medical device sector (the “Draft...more
On May 12, Chinese Food and Drug Administration (CFDA) issued Policy Notice No. 55, entitled “Policies Relevant to the Protection of the Rights and Interests of Innovators for the Encouragement of Innovation in Drugs and...more
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
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
The China Food and Drug Administration recently published a draft regulation setting minimum standards for medical device distribution. The regulation sets forth requirements for procurement, delivery acceptance, storage,...more