Generic Industry’s Perspective on the New GMP

InitiativeMay 21, 2003

Generic Pharmaceutical Association

Kenneth Lavin, M.Sc. Director, Regulatory Compliance

TEVA 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.