Generic Industry’s Perspective on the New GMP Initiative May 21, 2003 Generic Pharmaceutical Association Kenneth Lavin, M.Sc. Director, Regulatory ComplianceTEVA Pharmaceuticals USA
Risk-Based Approach • Definition • Implementation • Benefits • Dialogue • Guidance
Changes to Approved Applications • Interim Specifications • Development Report: • Guidelines • How to be used • No Negative Impact on Review • Goals
Pre-Approval Inspections • No longer universally necessary • Except Novel Compounds & New Technologies • Chemistry Reviewer Inspections • No Delays
Communications • 483 Dispute Resolution • Publish Internal FDA polices and Procedures • Publish Control Documents • Proceduralize Pre-ANDA meetings
Summary – Guidance & Procedures • GPhA welcomes the opportunity to work with FDA, industry and academia on developing the science to create the procedures to allow for a new regulatory framework.