文档介绍：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
– A forum focusing on discussing CMC related technical topics
for ICH Quality Guideline advocacy has been established
between RDPAC CMC Focus Group and SFDA quality related
functions.
• QbD forum in Dec2010
• A forum focusing on managing manufacturing changes
for biological products (ICHQ5E) in Dec2011
– SFDA have reps on ICH GCG, and CDE sent expert to ICH Q11
EWG during Step-2 signing
Current Status of CMC Regulato