Spring Intro 2023

03/03/2023

Module 2 - What needs to be submitted? • Information required detailed in ‘Notice to applicants Volume 2b’. – Sufficient information should be included from each section to provide the quality reviewer with an overview of Module 3. • A quality overall summary is always required (separate open and restricted QOS needed if ASMF is used) • OBSERVED DEFICIENCIES – Information in module 2 differs to module 3 (module 3 / ASMF updated, but module 2 still refers to previous version) – No comment on QOS results presented in Module 3 – QOS on restricted part of ASMF not provided (the ASMF Holder)

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What do regulators expect to see in Module 3? • Quality requirements are laid down by Directives and Regulations – These are mandatory legally binding texts • However they are high level and generally non specific, provide a regulatory framework only • More detail is spelled out in non-mandatory guidelines , which provide flexibility, and advise on how and what data to generate Unlike legislation or pharmacopoeial monographs, guidelines are not mandatory, but need to be followed unless justified – Represent an agreed position – For industry give protection - an agreed, but not the sole approach – For Regulators - should not question the agreed approach – Avoid “checklist mentality” – Good science should always prevail!

03/03/2023

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