Regulatory Challenges

REGULATORY CMC CHALENGES

  • Lack of global harmonization
  • Increased compliance standards from health authorities
  • Changes triggered by enhancement of science, medicine and technology
  • Encourages risk-based approaches but yet conservative
  • Encourages implementation of modern science and technology
  • Heightened focus on geriatrics and pediatrics
  • Increasing regulations
  • Concerns about issues such as adulteration and counterfeits

Current Hot Topics in The CMC World

  • Starting Materials
  • Potential Genotoxic impurities
  • Discriminative Dissolution method and Bioequivalence
  • Drug-Device combination products
  • Establishing Biosimilarity
  • Breakthrough designated products
  • Post-approval Comparability
  • Quality by Design
  • Defining Critical Process Parameters
  • Comparability protocols for cell-line change Design Space and Control Strategy