上海CMC培训 Overview of Regulatory Framework and CMC Requirements in the US.pptVIP

PoskaCMCOverview 062810 Overview of Regulatory Framework and CMC Requirements in the US richard.poska@ Global Pharmaceutical Regulatory Affairs Presentation Goals Explore the role of science in FDA and ICH policy Review FDA regulatory CMC submission requirements and expectations Outline FDA submission review process and outcomes Summarize science/risk based approached to CMC submissions Impact of collaborative partnerships: Industry, academia, and FDA The one who moves a mountain begins by carrying small stones. US Drug Regulation Milestones 1820 United States Pharmacopeia established 1906 Food Drugs Act Interstate Commerce, Adulterated, Misbranded Drugs 1937 Sulfanilamide/Diethylene Glycol 1938 FDC Act (FDCA) passed Safety data Factory Inspections 1962 Thalidomide Kefauver-Harris amendments-efficacy Framework for US Pharmaceutical Regulation US Manufacturing Changes – 25 Years ago The Value of Guidances CMC Requirements -Post Approval Categories for reporting change is gauged on potential for adverse effects: Major (Prior Approval) Substantial potential Moderate (CBE) Moderate potential Minor (AR) Minimal potential US Manufacturing Changes - Today Desired State General Characteristics of “Traditional” Guidances Prescriptive (expectations and requirements defined) Allows defined flexibility Helps both regulators and industry focus on details Contributes to uniform interpretation and level “playing field” for all Guidances that are “prescriptive” Scale-Up and Post Approval Changes (SUPAC) Immediate Release Tablets Equipment Addenda Non-prescriptive Guidance Changes to an Approved NDA/ANDA Container Closure Systems Biopharmaceutics Classification System (Stratified Sampling and BU Draft) Comparability Protocols What role does/should science play? Impact of Knowledge Process Understanding The driver for new standards of pharmaceutical manufacture quality and regulation. Assessing the Product Does data support “fitness for use?” A. Pr