Module 9 2024

03/09/2024

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 often 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 • Also seeing increasing efforts in reliance between global regulators which is largely focussed on initial MAAs and GMP elements at the moment but will hopefully evolve over time

The Organisation for Professionals in Regulatory Affairs

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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 and this is an increasing reason for licence rejections in global regulators who publish this data (e.g. US FDA) • 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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