On 5 November, Xiao Ting, our life sciences and regulatory lawyer based in China, gave a presentation on the recently implemented PRC Regulations for the Administration of Human Genetic Resources (Regulations) to representatives from multinational medical device companies in Beijing.The Regulations are comprehensive administrative regulations governing the collection, storage, use and supply to foreign controlled companies of human genetic resources in China. The Regulations have been brought into the spotlight lately partly because of the enhanced legal liabilities for violations, including permanent injunctions for handling genetic resources materials and genetic resources information.Prior to her legal career, Ting participated in the renowned Structural Genomics program at the Chinese Academy of Sciences and then at the Structural Genomics Consortium established by the University of Toronto and the University of Oxford. Leveraging her background and prior experience advising life sciences clients in this area, Ting shared her views on the developments and impacts of the Regulations. During the seminar, she also addressed questions raised by the various company representatives, especially on different issues relating to the conduct of clinical trials by the pharma and medical device companies in China.
The Regulations on Administration of Human Genetic Resources (the “new Regulations”) entered into force on the 1st July 2019. These new Regulations were announced on 28 May 2019 by the China State Council and create a report-and-registration mechanism for research involving human genetics and human genetic resources.