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Aaron Gu is an associate in the firm’s Shanghai office. Mr. Gu advises multinational and Chinese companies on a range of corporate, regulatory and compliance issues, particularly those in the health care and life science industries, as well as cross-border transactions, including mergers and acquisitions, foreign direct investments and outbound investments.
- Advising a leading biotech company on its transactional and regulatory matters in China, Taiwan and Korea, including clinical trial agreements, service agreements with medical consultants, CROs and SMOs, informed consent form, clinical trial insurance, financing and mortgage agreements, etc.
- Advised a leading medical device company on its ex-China CFDA GMP inspection, meetings with meetings with government authorities, and post-inspection revisions to standard operating procedures regarding the post-market surveillance.
- Assisted business associations with commenting on draft regulations to the China Food and Drug Administration and other government authorities in China.
- Advised a leading multinational pharmaceutical company on the regulatory due diligence of its acquisitions of various pharmaceutical companies in China.
- Advised a leading multinational information technology company on its smart health initiatives in China.
- Advised a leading multinational pharmaceutical company to conduct a regulatory assessment of its patient support program.
- Advised a leading multinational pharmaceutical company on the regulatory requirement for its veterinary R&D in China.
- Advised a leading Nordic aluminum and hydropower company in the sale of its Chinese silicon subsidiaries for US$2 billion.
- Advised a leading aluminum extrusions company, in connection with a US$99 million investment, on its acquisition of a Chinese aluminum profile manufacturer.
- Advised a leading aluminum extrusions company on the establishment and operation of its joint venture of RMB630 million with a Chinese state-owned aluminum company.
- Advised Swedish Government in connection with the operation and de-registration of Swedish Pavilion of Shanghai Expo 2010.
Pro Bono
- Assisting Stanford Law School China Guiding Cases Project on subsequent development of Guiding Cases issued by China's Supreme People's Court.
- Assisted International Center for Civil Society Law on the development of charity law in China.
- Assisted a youth venture from an Ashoka program in setting up its own nonprofit entity in the US.
Memberships and Affiliations
- New York State Bar Association
- NYU Alumni Club in Shanghai, Committee Member
- Stanford Law School China Guiding Cases Project, Editor
- International Center for Civil Society Law, Fellow
February 4, 2021
By: Aaron Gu On December 30, 2020, the State Administration for Market Regulation (“SAMR”) issued a three-year action plan for improving the quality and safety of dairy products in China (the “Plan”), reflecting China’s commitment to continue strengthening the regulatory and legal standards for dairy products, The Plan sets forth eight quantitative goals for the ...
January 25, 2021
By: Muyun Hu On December 25, 2020, the Institute of Food Science and Technology (“IFST”) issued China’s first plant-based meat standard T/CIFST 001-2020 (the “Standard”). The Standard will take effect on June 25, 2021. The Standard is a group standard issued by a government sponsored industry association and adopted by its members.[1] Group standards can ...
December 9, 2020, Covington Alert
On October 17, 2020, the Standing Committee of National People's Congress (“NPCSC”), China’s top legislative body, adopted a Biosecurity Law (“Law”), which will go into effect on April 15, 2021. The Law reflects a growing area of regulation of drugs and medical devices in China that is separate from the regulations to ensure safety, effectiveness, and quality ...
April 29, 2020, Covington Alert
On March 30, 2020, the State Administration of Market Regulation of China, the parent agency of the National Medical Products Administration (NMPA), released a revised Drug Registration Regulation (Revised DRR).
April 6, 2020, Covington Alert
This alert provides an update on the regulatory measures regarding medical-use and industrial-use personal protective equipment (PPE) from China to combat COVID-19, including a brief summary of measures the U.S. Food and Drug Administration (U.S. FDA) is taking to facilitate import of PPE from China into the United States. The regulatory guidance from both ...
September 9, 2019, Covington Alert
On August 26, 2019, China’s Standing Committee of National People's Congress (“NPC) adopted a significant revision of the Drug Administration Law (“DAL”). The newly adopted DAL (“Revised DAL”) will go into effect on December 1, 2019. The Revised DAL is the first overhaul of the DAL since 2001.
June 18, 2019, Covington Alert
On June 10, 2019, the State Council (China’s chief executive agency) promulgated the long-awaited Regulation on the Administration of Human Genetic Resources (the “Regulation”), which will become effective on July 1, 2019. The Regulation supersedes the currently effective regulations and guidance on human genetic resources (“HGR”).
March 4, 2019, Covington Alert
On December 29, 2018, the State Council (China’s chief executive agency) opened a new pathway for drugs to come into China through a special zone in southern China. It suspended certain central regulations in the Bo Ao Lecheng International Medical Tourism Pilot Zone in Hainan Province (“Pilot Zone”) and permitted local authorities to make marketing decisions ...
May 23, 2017, Covington Alert
On May 11 and 12, 2017, the China Food and Drug Administration (“CFDA”) published drafts of four proposed policies in the form of circulars (or notices) for public comment. These “Proposed Policies” include significant reforms in the areas of the new drug and device approval process (“Circular 52”), clinical trial regulation (“Circular 53”), life-cycle ...
April 7, 2017, Covington Alert
On March 17, 2017, the China Food and Drug Administration (“CFDA”) released a notice to seek public comments on four proposed adjustments to China’s drug registration requirements (“Proposed Adjustments”) that will remove some barriers to applications for clinical trials and drug registrations of imported drugs (drugs that are manufactured outside of China). The ...
Doing Business in China?
Covington helps clients validate or recalibrate their existing strategies for doing business in and with China.