CRED Getting the CMC Dossier Right 2024

28/08/2024

Role of Pharmacopoeias

• Ensures patients receive high-quality medicines that are safe and effective

• Toolkit for pharmaceutical companies developing, manufacturing and assessing medicines. • Complying with pharmacopeial requirements is a regulatory expectation • Increases probability of regulatory success • Increases Agency confidence in submissions • Reduces Agency questions during review • Reduces likelihood of Agency inspection or enforcement action • Increases development and lifecycle flexibility by harmonizing and globalizing testing requirements

The Organisation for Professionals in Regulatory Affairs

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Harmonisation

• Pharmacopoeial Discussion Group (PDG) formed in 1989 • EDQM | MHLW | USP | WHO (observer, since 2021) | IPC (since 2022) • Harmonised pharmaopoeial texts excipient and general chapters • ICH Q4 EWG established in 2003 to harmonise 11 General Test Chapters discussed during Q6A development • In 2018, PDG took responsibility to maintain current 16 ICH Q4B General Test Annexes • Harmonised texts are interchangeable – avoids redundant testing by companies • Texts cannot be unilaterally amended • Monographs include harmonisation statement • Harmonisation ≠ Harmonisation • Section 2 of each Q4B Annex provided non-harmonised requirements and region-specific information to be provided in the submission

The Organisation for Professionals in Regulatory Affairs

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