{"slug":"cn","tag":"cn","variants":["cn"],"description":"No description yet","count":4,"kinds":{"term":4},"related":[{"slug":"law","tag":"law","shared":4}],"records":[{"id":"china-drug-administration-law","kind":"term","name":"China Drug Administration Law (2019) and expedited pathways","route":"/terms/china-drug-administration-law/","tldr":"China rewrote its drug law in 2019 and its registration rules in 2020, writing in priority review, conditional approval, breakthrough designation and acceptance of foreign trial data, which turned the world's slowest big regulator into one that approves cancer drugs within months of the FDA."},{"id":"pipl","kind":"term","name":"PIPL (China Personal Information Protection Law 2021)","route":"/terms/pipl/","tldr":"China's 2021 privacy law, in force since November 2021, treats medical and health data as sensitive information requiring separate consent, and together with the Data Security Law restricts sending patient data out of China, which shapes every international cancer trial run there."},{"id":"china-hgr-rules","kind":"term","name":"China Human Genetic Resources rules (2019, 2023)","route":"/terms/china-hgr-rules/","tldr":"Chinese rules that treat blood, tissue and genetic data from Chinese people as a national resource: foreign organisations cannot collect them, international collaborations need approval or filing, and exporting samples or sequence data needs a permit, which affects every global cancer trial with Chinese sites."},{"id":"china-vbp-nrdl","kind":"term","name":"China National Reimbursement Drug List negotiation and volume-based procurement","route":"/terms/china-vbp-nrdl/","tldr":"China's two price levers: an annual negotiation, since 2017, in which a new cancer drug wins national reimbursement only by cutting its price, often by half or more, and tenders since 2018 in which generic makers bid for guaranteed hospital volumes, collapsing prices of off-patent drugs."}]}