Dealing in the Chinese drug data market has never been easy. Western drug companies that are now doing multi-regional clinical studies that include China, and Western drug companies licensing drugs from Chinese originators, oftentimes need China data to be successful with drug registrations globally. The China Cyberspace Administration issued an updated statement on their Standard Contract for the Cross-border Transfer of Personal Information in February. This contract outlined new regulations on data transfer under the Personal Information Protection Law (PIPL).
Specifically, if a company transfers more than 10,000 subjects’ personal data, it will need to file for regulatory approval. In addition to such situations, the data recipient located overseas needs to sign a contract with the information provider. In addition, this statement says that the information provided does not require a consent form to be signed by individuals whose data is transferred. To help better organize data security, China will establish a National Data Bureau.
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://www.ropesgray.com/en/insights/alerts/2022/07/china-promulgates-new-implementing-rules-to-facilitate-cross-border-transfers-of-data