Module 9 2021

16/03/2021

Practical Considerations (cont.)

• Beyond ICH countries managing post-approval changes gets considerably more complex and costly • Many companies tailor the Module 3 to local markets, redact Module 3 and/or clearly define which details will be maintained • Without that consideration even simple post-approval changes can take 3-5 years to secure global approval • ICH Q12 is seeking to solve some of this but the benefits of this will take time to be evident both within and outside of ICH countries

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Conclusions

• Getting Module 3 correct is important ● Includes location and level of detail

• The data presented in Module 3 must allow the regulators to assess alongside nonclinical and clinical data that the product proposed is suitable for the stage of clinical study (CTAs) or for commercial approval (MAA/NDA/BLA etc) • Inadequate or insufficient CMC information may lead to non- approval • Conversely too much CMC detail may lead to additional questions or significant lifecycle burden

The Organisation for Professionals in Regulatory Affairs

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