CRED 8 Presentations

01/07/2024

Example: Starting material

• Generic application for powder and solvent for solution for injection/ infusion; • Proposed starting material of the active substance does not meet the requirements of ICH Q11 • Request for redefinition starting material • Redefinition results in additional intermediate manufacturers: need for updated QP declaration which should be available before the end of EU procedure – Inadequate QP declaration could be a potential ground for refusal of the application!

The Organisation for Professionals in Regulatory Affairs

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Example: active substance specification

• Type II variation application for introduction of manufacturer of the active substance supported by ASMF; • Major Objection (MO): request to include limits for potential genotoxic impurities in the active substance specification; • API manufacter has included these limits as requested; • However: MO not yet resolved - MAH should update his active substance specification in line with the (approved) limits of the active substance manufacturer

The Organisation for Professionals in Regulatory Affairs

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