从工业界视角看中国CMC法规环境现状.pdfVIP

Current Status of CMC Regulatory Environment in China from Industry Perspectives Min Gui, PhD Global Regulatory Sciences-CMC, China CMC, Operation and Regulatory Strategy Management Bristol-Myers Squibb Presentation at Vogel Pharmaceutical Engineering International Forum 2012 June 28-29, 2012 Shanghai, China Disclaimer This presentation is developed with major contents from RDPAC CMC Position Paper issued by RDPAC CMC Focus Group on December 5, 2011. OUTLINE Current Status of CMC regulatory environment in China − Status of ICH Quality Guidelines in China − Regulatory Pathways for CMC Changes During CTA − Technical Guideline Development in China − NIFDC Sample Testing for Biological CTA − SFDA QbD Status − Post Approval CMC Changes and License Renewals − Multiple drug substance and/or drug product manufacturing sites in one registration application − SFDA “DMF” development − SFDA draft “Provision on Strengthening Management of Excipients for Pharmaceutical Use” − Chinese Pharmacopoeia (ChP) revision − SFDA CTD template for registration submissions Summary 3 Current Status of CMC Regulatory Environment in China Status of ICH Quality Guidelines in China  SFDA has demonstrated significant efforts and interests in understanding ICH guidelines and applied some when believed appropriate – SFDA ICH Study Group formed in 2009 with a Quality Working Group with reps from all SFDA quality related functions and RDPAC reps –