On March 14, 2025, Han Kun lawyer Aaron Gu was invited to be appointed as a member of the Digital & Intelligent Medical Ethics Review Panel under the Shanghai Ethics Committee for Clinical Research. Recently, the Review Panel held its first working meeting. Mr. Gu was invited to attend as a member and delivered a thematic presentation on "Overview of Ethics Review Systems and Key Issues in Medical Data Application".
The Shanghai Ethics Committee for Clinical Research was established in December 2017 and is affiliated with the Shanghai Clinical Research Center. It was jointly established by the Shanghai Municipal Health Commission and the People's Government of Xuhui District. Its primary functions include conducting ethics reviews, coordinating and providing guidance on ethics, offering ethics training and consultation, and engaging in academic research and exchange. Currently, the Shanghai Ethics Committee is composed of committee members, independent consultants, and the Secretariat. The members and consultants are senior experts in disciplines such as medicine, pharmacology, bioethics, statistics, and law and social representatives.
To promote the orderly, compliant circulation and utilization of health data in the city, relevant Shanghai departments guided the establishment of the Shanghai Health Digital & Intelligent Innovation Laboratory. Relying on the Regional Ethics Committee, they formed the Digital & Intelligent Medical Ethics Review Panel to specifically undertake ethical review work for the development and utilization of health data in Shanghai. This Review Panel consists of multiple academicians, experts from diverse professional fields, and responsible personnel from medical institutions and related organizations, ensuring the scientific rigor and professionalism of the ethics review work.
Mr. Gu focuses on corporate, regulatory compliance and transactional services for the life sciences, biopharmaceutical, medical, and healthcare industries, including biosecurity and human genetic resource issues, clinical trial matters, product marketing authorizations, GxP compliance, drug licensing and collaboration (license-in/out), as well as regulatory issues involved in venture capital and private equity investments, mergers and acquisitions, and foreign and outbound investments in the life sciences industries. Mr. Gu also provides advocacy advice for draft laws and regulations released by the NMPA and other Chinese governmental authorities. Specifically, Mr. Gu's practice covers a full range of products including drugs (biologics and chemical drugs), medical devices, IVDs, cosmetics, general foods, special foods (health foods, foods for special medical purposes, and infant formulas), animal drugs, and animal foods. Mr. Gu has been interviewed multiple times by media such as 36Kr, Caixin, Yicai, E Drug Manager, Discover Magazine, International Pharmaceutical News, Het Financieele Dagblad (The Financial Daily, a major Dutch media outlet ), Jiemian, the Economic Observer, Shenlan Outlook, and Thomson Reuters.
