OH-EBASHI and HANLING CHINA LEGAL NEWSLETTER 2022 July Issueを発行いたしました。

****************************************************************************************************

1.　Legal Compliance of Workplace Surveillance in China -From a Personal Information Protection Perspective （翰凌律师事务所 パートナー 孫 宇川）
A few months ago, a piece of rather interesting news in China raised debates about to what extent an employer can impose surveillance upon its employees in workplaces. The news reported that one major e-commerce company in China has internally announced sanctions upon some of its employees on the ground of excessive access to workirrelevant mobile applications during work hours. The company was able to collect various data such like the length of access or quantity of data that has been exchanged by each particular employee's use of his or her mobile phones to access certain applications (Tik Tok or online shopping applications) via the company's internal wireless network. Those who support such an action argues that workplace surveillance is necessary to maintain the employment disciplines as well as the security. While others think such a surveillance scheme is only an undue intrusion to employees' privacy. ...(続きはPDFをご覧ください。）

2.　China's Life Sciences and Healthcare-No.2 －The Good Vigilance Practice rule in China (弁護士法人大江橋法律事務所 パートナー 高槻 史・翰凌律师事务所 パートナー 孫 宇川　共著）
I. China GVP
This article will introduce the drug vigilance activities required by the new Good Vigilance Practice ("GVP"), enacted on May 7, 2021, and come into effect on December 1, 2021. The GVP will be applied to MAHs and NDA applicants conducting clinical trials.
Before the adoption of the GVP, the Administration Measures on Reporting and Monitoring of Drug Failure Reactions (Ministry of Health Order No. 81, effective as of July 1, 2011) and the Public Notice of the State Pharmaceutical Administration on Report of Adverse Drug Reactions (the "No. 66 Notice") issued in 2018 constituted the basic legal framework of monitoring and reporting of adverse drug reactions in China. According to the NMPA's explanation, NMPA will amend the Administration Measures on Reporting and Monitoring of Drug Failure Reactions (Ministry of Health Order No. 81) and apply it to the drug vigilance activities conducted by medical institutions and drug sales companies (wholesale and retail). .....( 続きはPDFをご覧ください。）