CRED Getting the CMC Dossier Right 2024

29/08/2024

Common deficiencies

▪ Review of CPS EAG papers: 2012 -2016

▪ Chemistry Pharmacy & Standards Expert Advisory Group

▪ Supports the Commission on Human Medicines (CHM)

▪ Review of all Abridged Applications for period 2012-2016 - all Major Objections [PSRPH]

Five main themes emerge:

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▪ Starting materials used in the synthesis of drug substance

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Impurities

▪

Particle size

▪

Polymorphism/ solvates

▪

GMP/QP declarations

The Organisation for Professionals in Regulatory Affairs

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Common deficiencies

▪ Review of CPS EAG papers: 2020

▪ Review of all initial applications with MOs (n= 105)

DS Major Objections (2020, CPS)

▪

Total DS MOs: 72

▪

Total DP MOs: 261

10 15 20 25 30

▪

Breakdown of all DS MOs

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Top 3 issues:

0 5

▪

Starting materials

▪

Impurities

▪ QP declarations & GMP certificates

The Organisation for Professionals in Regulatory Affairs

20

10