China bioequivalence guidelines

center for drug evaluation (cde) china
cde china regulatory
china center for drug evaluation website
china gcp guidelines 2020
china drug registration regulation 2020
china cde guidelines
conducting clinical trials in chinapharmaceutical regulations in china

Main topic of this collection is Bioavailability / (in-vivo-) Bioequivalence, although GCP / GLP , dissolution/ BCS , pharmacokinetics, bioanalytics and -In 2013, CFDA issued guidelines that required generics to achieve bioequivalence to brand-name drugs in a drive to improve China's pharmaceutical industry. The content of studies should comply with the Guideline of Good Clinical Practices. However, the application of protocol for conducting bioavailability and China FDA has said that generic drugs need to show bioequivalence to the related branded products, adding that the current use of locally made generics will no Summary of China's clinical research requirements and relevant sources related to Phase I through Phase IV clinical trials and bioequivalence studies.