Getting drug and patient data transferred from China to the West is not an easy process. Data transfer requires approval from China’s Ministry of Science and Technology (MOST). Drug companies need pre-approval or record filing with the Human Genetic Resources (HGR) Administration of China. China considers this part of its national security.
Late last year, China issued a new regulation making it even more difficult to export data abroad – “New Measures for the Security Assessment of Outbound Data Transfers”. Pharma companies need to determine if these new measures will affect them and if so, comply by February 28, 2023. The Cyberspace Administration of China, under these new measures, will check if specific situations occur. These situations refer to the outbound transfer of important data, personal information, etc. by data/information handlers and others. While personal data export is covered somewhat by HGR regulations, important data is not. This adds a new category of data that drug companies must consider when trying to export China data overseas. Please keep in mind that requirements for data export also include specific details on quantitative amounts to be exported.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://goodlifesci.sidley.com/2023/01/24/it-is-now-more-difficult-for-international-pharma-to-transfer-data-out-of-china/#:~:text=China’s%20new%20Measures%20for%20the,assessment%20if%20they%20need%20it.