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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-05-27
- Length: 10m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-05-27-239-ich-q12-whats-binding-established-conditions-and-post-approval-changes
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/239---ICH-Q12-Whats-Binding--Established-Conditions-and-Post-Approval-Changes-e3jt5h6

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-05-27-239-ich-q12-whats-binding-established-conditions-and-post-approval-changes#t=0) Introduction to ICH Q12 and Post-Approval Change

## Topics

- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

large enterprises

## Mentioned

- ICH Q12 (other)
- FDA (other)

## Related episodes from other shows

- [#389: Pre-determined Change Control Plans](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-31-389-pre-determined-change-control-plans) (Global Medical Device Podcast)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [CDRH Proposed Guidance for FY 2023](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-22-cdrh-proposed-guidance-for-fy-2023) (Global Medical Device Podcast)
- [#445: ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech) (Global Medical Device Podcast)

## Citing this page

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