CRED Getting the CMC Dossier Right 2024

28/08/2024

European Legislation and Guidelines

• Directive 2001/83/EC, as amended • 3AQ11a Specifications and Control Tests on the Finished Product

• EMA/CHMP/CVMP/QWP/336031/2017 Reflection paper on the dissolution specifications for generic solid oral immediate release products with systemic action • EMA/CHMP/CVMP/QWP/199250/2009 corr Guideline on setting specifications for related impurities in antiobiotics • EMA/CHMP/QWP/428693/2013 Guideline on quality of oral modified release products • EMA/CHMP/QWP/608924/2014 Guideline on quality of transdermal patches • EMA/CHMP/QWP/545525/2017 Rev. 2 Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials • EMEA/CHMP/QWP/306970/2007 Guideline on radiopharmaceuticals • CHMP/QWP/708282/2018 Draft guideline on quality and equivalence of topical products • CPMP/QWP/1719/00 Rev 1 Guideline of medicinal gases

The Organisation for Professionals in Regulatory Affairs

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ICH Universal Tests / Criteria – Small Molecule

• Description • A qualitative description of the dosage form should be provided (e.g., size, shape, and color). • Identification • Establish identity of drug substance – specific vs. two non-specific, orthogonal methods • Counterion, colourants, antimicrobials, preservatives, antioxidants • Assay • Specific, stability indicating method to determine strength (content) • Impurities • Organic and inorganic degradation impurities • Residual solvents • Elemental impurities • Genotoxic impurities • Nitrosamines, etc

The Organisation for Professionals in Regulatory Affairs

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