CRED Getting the CMC Dossier Right 2024

28/08/2024

The Need to Harmonise

• Prior to 1990s, proliferation in national laws and guidelines as a result of various safety incidents

• Increasing globalisation, yet drug regulatory technical requirements were diverging globally

• Costly duplication of tests to differing standards

Lengthy approval delays

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• Budgetary restrictions on rising healthcare costs

• Ethical considerations of animal drug testing and duplicated human clinical data

• Access to medicines for patients in more geographies

The Organisation for Professionals in Regulatory Affairs

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ICH and development of CTD

• European Union progress towards a single market in 1980s showed harmonisation was possible • Trilateral harmonisation discussions launched 1990 – US, Japan & Europe – birth of International Conference on Harmonisation (ICH) • Industry representatives are equal partners with Regulatory Agencies • Topics for harmonisation divided into Quality (Q), Safety (S), Efficacy (E) & Multidisciplinary (M) • ICH M4 - the Common Technical Dossier - agreed Nov 2000, implemented simultaneously July 2003

The Organisation for Professionals in Regulatory Affairs

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