研究伦理学介绍
研究伦理学介绍
General legal system in China a National level vs. Provincial/ city level Laws vs administrative regulations Administrative rules and documents issued by departments /agencies National People s Congress NPc vs State Council ■Ⅰ ocal people s congress vs. local government
General legal system in China ◼ National level vs. Provincial/city level ◼ Laws vs. administrative regulations ◼ Administrative rules and documents issued by departments/agencies ◼ National People’s Congress (NPC) vs. State Council ◼ Local people’s congress vs. local government
Ministry of Health(MOh) ■MOH a Hospitals and Community Health Care Services a Public Health Services and Center(s) of Diseases Control and prevention
Ministry of Health (MOH) ◼ MOH ◼ Hospitals and Community Health Care Services ◼ Public Health Services and Center(s) of Diseases Control and Prevention
State Drug Administration (SDa) Drugs---Western Drugs and Traditional Chinese Medicines Functional food---Dietary supplements ■ Common foods ■ CoSmetic products Other health products
State Drug Administration (SDA) ◼ Drugs---Western Drugs and Traditional Chinese Medicines ◼ Functional food---Dietary supplements ◼ Common foods ◼ Cosmetic products ◼ Other health products
GCP Issued by SDa (1999) 口药晶临床试验管理规范(GCP 国家药品监督管理局令(第13号 九九九年九月一日发布
GCP Issued by SDA (1999) ◼ 药品临床试验管理规范(GCP) ◼ 国家药品监督管理局令(第13号) 一九九九年九月一日发布