Spring Intro 2023

06/03/2023

Which agencies to target

• Therapeutic Area expertise – Guideline development

• Biotechnology drug manufacture expertise – Particularly important if complex comparability exercise performed • Become more difficult now companies cannot input into rapporteur selection in EU – Important to meet with selected rapporteur/co-rapporteur as soon as assigned – Additional EMA support for small companies (SMEs) – PRIME (Priority Medicines Scheme) may help establish agency interest • Early involvement of Health Technology Agencies (HTAs) – Combined EMA/HTA scientific advice in EU – ILAP and National Institute of Clinical Excellence (NICE) in UK

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Overview

• What is a biotechnology product

• Key regulatory aspects to consider

• Filing Biotechnology Products

• Advanced Therapy Medicinal Products

• Hot Topics and Conclusions

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