On September 8, 2024, the Ministry of Commerce, together with the National Health Commission and the National Medical Products Administration (hereinafter referred to as the "Three Departments"), publicly issued the Notice on Carrying Out Pilot Programs to Expand Opening-Up in the Healthcare Sector (hereinafter referred to as the "Notice")...

近期，部分医药行业动态引发了广泛关注，临床研究合规问题再次成为众多企业重点讨论的话题。

On March 15, the website of the Central People's Government released State Order No. 777 "Decision of the State Council on Amending and Abolishing Certain Administrative Regulations" ("Decision")...

自国务院于2015年发布《关于改革药品医疗器械审评审批制度的意见》（国发〔2015〕44号）并启动药品医疗器械审评审批制度改革工作以来，我国不断߾

2017年5月9日，最高人民法院、最高人民检察院发布《最高人民法院、最高人民检察院关于办理侵犯公民个人信息刑事案件适用法律若干问题的解ດ

In recent years, an increasing number of multinational pharmaceutical and medical device companies have been exploring local manufacturing options in China.

This article will provide a brief overview of the Regulations based upon relevant provisions of the Promotion Law.

近期，医药行业正掀起一股"管线分拆项目"（"Spin off-NewCo"，或称"SON"模式）的热潮。短短两个月，笔者即接手了近十起管线分拆项目。

On June 29, 2022, the National Medical Products Administration ("NMPA") publicly released the "Implementation Plan for Supporting Hong Kong and Macao Drug Marketing Authorization Holders...

On August 31, 2022, the Cyberspace Administration of China (the "CAC") issued the Application Guidelines for Security Assessment of Cross-border Data Transfer (1st Edition)...

2022 年 4 月 2 日，中国证券监督管理委员会...

On September 12, 2022, U.S. President Joe Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable...

Since the General Office of the State Council issued the "Opinions on Promoting the Development of "Internet + Medical Health" on April 25...

On February 17, 2023, the New Filing Rules was released by the China Securities Regulatory Commission ("CSRC"), which will come into force on March 31, 2023.

On March 28, 2023, the Hainan Provincial People's Government officially issued the "Regulations on the Administration of Imported Drugs and Medical Devices Urgently Needed in Clinical Needs...

近日，国家卫生健康委员会（下称"国家卫健委"）、国家中医药局和国家疾控局三部委联合发布了...

在全球化背景之下，中国医药企业正站在创新与合作的新风口，迎接前所未有的发展契机。与此同时，海外投资者与医药企业亦在敏锐捕捉投$

This article provides a brief analysis of the drug regulatory data protection system and its implications for pharmaceutical industry.

2017年2月17日，中国证券监督管理委员会（下称"中国证监会"）发布了《关于修改〈上市公司非公开发行股票实施细则>的决定》，对《上市公司非公&#

In the "Interpretation of China's Annual Drug Evaluation Report (2015-2021) - Review of the Achievements of China's Drug Evaluation and Approval System Reform (Part 1)", we have summarized and refined the key contents...