Module 9 2021

19/03/2021

The Principle of Comparability • Compare ‘before and after’ the change • Comparable = ‘highly similar’, not identical • Should be phase appropriate – ‘Suitable for use’ • Expectation is no adverse impact on Safety & Efficacy despite differences • Hierarchical approach to comparability assessment • Quality data  Nonclinical data  Clinical data • The point at which comparability is declared depends on robustness of data at each stage • Case-by-case • Potentially limited in our knowledge in advance whether a minor or major change has ‘foreseeable consequences ’

The Organisation for Professionals in Regulatory Affairs

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EU Guidance is in Line with ICH Q5E Principles

• Guideline on Comparability of Medicinal Products Containing Biotechnology- Derived Proteins as Active Substance: • Quality Issues (CPMP/BWP/3207/00/Rev 1) • Revised December 2003 • Non-clinical and Clinical Issues (CPMP/3097/02) • Operational June 2004 • Follows the same general principle • Hierarchical approach to comparability assessment

The Organisation for Professionals in Regulatory Affairs

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