Module 3 - Strategic case studies in practice

Borg 2009 During evaluation of 52 MAAs, 1,991 concerns were raused at Day 120 on M3:

• 32 of these were major objections from 13 MAAs DRUG SUBSTANCE MAJOR OBJECTIONS:

• Mostly relating to various aspects of impurities, and specifications

DRUG PRODUCT MAJOR OBJECTIONS:

• Mostly relating to Pharmaceutical Development, control of drug product, and stability