Module 9 2021
22/03/2021
Regulatory review - ISI
Immunogenicity related data: presented in multiple parts of the CTD (e.g., manufacturing, non-clinical, clinical). From a reviewer’s perspective: often difficult to understand the rationale of the immunogenicity studies and to find the relevant data unnecessary questions by the assessors (delays and impact on the outcome of the review)
Introduction of an Integrated Summary of Immunogenicity (ISI)
• 1.8.2 Risk management plan • 2.7.2.4 Special studies
• 2.7.3 Summary of clinical efficacy • 2.7.4 Summary of clinical safety • 5.3.1.4 Reports of bioanalytical and analytical methods for human studies • 5.3.3 & 5.3.5 Clinical study reports (incl. raw ADA data from ADA testing) • 5.3.5.3 Integrated summary of immunogenicity
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Guidelines European Medicines Agency (EMA)
• Guideline on Immunogenicity Assessment of Therapeutic Proteins EMEA/CHMP/BMWP/14327/2006 Rev.1 Final document released 2017
• Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use.
EMA/CHMP/BMWP/86289/2010 Final document released 2012
• Guideline on similar biological medicinal products containing biotechnology- derived proteins as active substance: non-clinical and clinical issues. EMEA/CHMP/BMWP/42832/2005 Rev1 Final document released 2015
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