# 221 - What Is ICH and Why It Matters

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-01-07
- Length: 14m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-01-07-221-what-is-ich-and-why-it-matters
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/221---What-Is-ICH-and-Why-It-Matters-e3d9uaf

## Summary

Subhi Saadeh, host of Let's Combinate and founder of Let's Combinate BioWorks, explains the International Council for Harmonisation (ICH) and its critical role in drug-device combination products. He details the history of ICH, from its 1990 founding to its 2015 legal entity status, and outlines the five-step guideline development process involving regulators like the FDA, EMA, and PMDA. Saadeh emphasizes how ICH guidelines, particularly the Quality (Q) series such as Q8, Q9, Q10, Q12, and Q13, shape global expectations for lifecycle management, stability, and risk in products like auto-injectors and refilled syringes.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-01-07-221-what-is-ich-and-why-it-matters#t=0) Introduction: Subhi Saadeh and the ICH Series
- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-01-07-221-what-is-ich-and-why-it-matters#t=0) What is ICH? History and Global Scope
- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-01-07-221-what-is-ich-and-why-it-matters#t=0) Evolution of ICH Guidelines: Q1-Q10 and Beyond

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

established companies

## Mentioned

- Let's Combinate BioWorks (other)
- ICH (other)
- FDA (other)
- EMA (other)
- PMDA (other)
- Health Canada (other)
- Swiss Medic (other)
- WHO (other)
- Combination Products Coalition (other)
- ASTM Committee E55 (other)
- AAMI (other)
- Q1 (other)
- Q2 (other)
- Q3 (other)
- Q4 (other)
- Q6 (other)
- Q7 (other)
- Q8 (other)
- Q9 (other)
- Q10 (other)
- Q11 (other)
- Q12 (other)
- Q13 (other)
- Q14 (other)

## Related episodes from other shows

- [#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)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (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)
- [Meet a Guru: Karen Schuyler](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-08-meet-a-guru-karen-schuyler) (Global Medical Device Podcast)
- [#404: MedTech 101: What You Need to Know About the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-05-01-404-medtech-101-what-you-need-to-know-about-the-medical-device-industry) (Global Medical Device Podcast)

## Citing this page

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