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Global health authorities review and approval trends for CMC post approval changes 2018-2024

Karim Kacimi1, Sunny Kamlesh Dave2, Scott Roberts3

  • 1Global Regulatory Policy & Intelligence, Novo Nordisk A/S, Søborg, Denmark. KRQI@novonordisk.com kacimikarim2490@gmail.com.

PDA Journal of Pharmaceutical Science and Technology
|April 29, 2026
PubMed

Keywords:
CMC post-approval changes (PAC)ChemistryReview timeglobal health authoritiesmanufacturing and controls (CMC)national regulatory authority (NRA)regulatory review trends

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