The International Council for Harmonisation (ICH) M4Q(R2) Expert Working Group has developed a mock example to illustrate the potential structure and presentation of information in the revised Modules 2.3 and 3 of the Common Technical Document \u2013 Quality.<\/p>\n
Sakura Bloom R2 serves as a draft illustrative example for a small-molecule product. This mock-up demonstrates how the concepts and organisation proposed in the draft M4Q(R2) Guideline may be applied in practice, supporting a clearer understanding of the intended dossier format and content.<\/p>\n
The mock example is provided for educational and illustrative purposes only. It does not represent an actual regulatory submission and may not fully align with all ICH Quality guidelines or region-specific requirements. Its purpose is solely to facilitate understanding of the draft M4Q(R2) concepts.<\/p>\n
The Common Technical Document (CTD) is a globally harmonised format developed by ICH for submitting quality, safety and efficacy information to regulatory authorities when applying for the approval of pharmaceutical products.<\/p>\n
The draft ICH M4Q(R2) Guideline defines how pharmaceutical companies organise and present quality information in regulatory submissions. It focuses on Module 2.3 (Quality Overall Summary) and Module 3 (Quality) of the CTD.<\/p>\n
The draft ICH M4Q(R2) Guideline is open for public consultation. Stakeholders are invited to review the draft guideline and provide feedback specifically on the M4Q(R2) guideline itself, rather than on the mock example.<\/p>\n
>> Find the Sakura Bloom R2 mock example here<\/strong><\/a><\/p>\n