Hardware Podcasts

239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes

Let's Combinate · 27 May 2026 · 10m

What this episode covers

Subhi Saadeh, founder of Let’s Combinate, explains ICH Q12, a guideline for managing post-approval changes in pharmaceutical products. He details the distinction between legally binding 'Established Conditions' (ECs) and non-binding 'supporting information', and outlines the three reporting categories for changes. Saadeh also describes the role of Post-Approval Change Management Protocols (PACMPs) and the Product Lifecycle Management (PLCM) document in creating a predictable regulatory framework.

Most relevant to

large enterprises

Topics

Mentioned

Also
ICH Q12, FDA

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