CRED Getting the CMC Dossier Right 2024

29/08/2024

New Chemical Entities vs Established Drug Substances

Paracetamol

Established DS

● Quality standards may be established /may be pharmacopoeial – CEP? – ASMF? – already used in another procedure? ● Intrinsic stability of molecule known

patiromer sorbitex calcium

⚫ NCE

● (often) scientific advice sought

● Considerable literature references may exist

● History of development data – Much data available ● (often) simplified supply chain

● The above may allow somewhat reduced data set for small-molecule APIs – e.g. submission with less detailed impurity discussion, polymorph confirmation rather than polymorphism screening

● Detailed understanding

The Organisation for Professionals in Regulatory Affairs

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New Chemical Entities vs Established Drug Substances

⚫ BUT:

● International quality standards for established APIs becoming similar to NCEs!

● ICH and other emerging standards for NCEs now imposed on established substances via pharmacopoeia and/or supplementary local guidelines – EU, USA, WHO, ASEAN ............. – especially purity – including heavy metals (ICH Q3D on elemental impurities), residual solvents, to some degree genotoxic risk material

The Organisation for Professionals in Regulatory Affairs

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