INSTITUTION PROFILE / CELL CULTURE TECHNOLOGY
International Council for Harmonisation (ICH)
Not law, yet its common rules become every major regulator's review standard
ICH is an international association that brings together medicines regulators, led by those of the U.S., Europe and Japan, and pharmaceutical industry bodies. Its secretariat is in Switzerland. Its job is to write internationally shared guidelines on how the quality, safety and efficacy of medicines should be demonstrated. For biologics made in cell culture, the benchmarks for viral safety (Q5A) and for control of the cell lines used in production (Q5D) are ICH guidelines. But ICH itself neither approves nor inspects anything, and its guidelines have no legal force of their own. They take effect when each regulator brings them into its own rules. This profile looks at one question only: how much influence ICH has over cell culture technology.
- ICH in 30 seconds
- What kind of body it is: the four types of influence
- What it does in cell culture technology
- How far its influence reaches (powers and geography)
- Companies and organisations involved
- Outlook
- Glossary, references and claim-to-source audit
1. ICH in 30 seconds
ICH guidelines are not laws in themselves, but documents recommended for adoption by regulators in each region. The cover of each guideline states that at Step 4 of the process the final draft "is recommended for adoption to the regulatory bodies of ICH regions" Sourced. At the same time, ICH's annual report states that "ICH Regulatory Members commit to implementing all ICH Guidelines" Sourced. So influence does not flow straight from "ICH decides" to "companies comply". It works in two stages: agreement at ICH, then adoption by each regulator into its own rules, then compliance by companies. Because the U.S., the EU, Japan, China and others all adopt them, the guidelines end up as the review standard in the world's major markets.
2. What kind of body it is: the four types of influence
Unlike the companies in this series, the institutions that appear in cell culture coverage make neither cells nor medicines. What separates them is the route by which they influence the industry, and that gives four types.
3. What it does in cell culture technology
ICH guidelines fall into four groups: Quality (Q), Safety (S), Efficacy (E) and Multidisciplinary (M). The ones that bear most directly on cell culture technology are the Quality (Q) guidelines. All of them exist to align, internationally, what data a company must present for regulators to be satisfied about quality.
| Guideline | What it covers | Stage and date | Relevance to cell culture technology |
|---|---|---|---|
| Q5A(R2) | Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin | Step 4: 1 November 2023 | Covers cytokines and antibodies made in cell culture, and viral vectors such as AAV. Cell therapies are out of scope, though the guideline says its principles may be applied where relevant, for example to starting and raw materials |
| Q5D | Origin and characterisation of the cell substrates (cell lines) used in production, and how cell banks are prepared | Step 4: July 1997 | The standard for controlling the starting point of cell culture, such as the master cell bank |
| Q5E (plus an ATMP annex) | How to show that products made before and after a manufacturing process change are comparable | Main guideline: November 2004. An annex for ATMPs was adopted as a new topic in May 2025 and is being drafted | The question comes up every time culture media or culture equipment is changed. The annex adds thinking specific to cell and gene therapies |
| Q8(R2) to Q11 | Pharmaceutical development (Q8), quality risk management (Q9), pharmaceutical quality system (Q10), and development and manufacture of drug substances (Q11) | Q9(R1): 18 January 2023. Q11: 1 May 2012 | The foundation of QbD (building quality in from the design stage). Q10 and Q11 also cover biologics |
| Q12 | A framework for managing post-approval changes to manufacturing (CMC changes) in a predictable way | Step 4: 20 November 2019 | Of the 19 regulatory members, only four (the U.S., Japan, China and Nigeria) have implemented it. The EU's implementation is in progress |
| Q13 | Continuous manufacturing (feeding in materials and removing product continuously) | Step 4: 16 November 2022 | Covers chemical drugs and therapeutic proteins. Its principles may also apply to other biologics |
| Q14 | Principles of analytical procedure development | Step 4: 1 November 2023 | Design and control of the analytical methods used to measure culture processes and products |
| Q3E (draft) | Assessment and control of substances that leach out of manufacturing equipment and containers (extractables and leachables) | Step 2 (draft for consultation): 1 August 2025 | Cell and gene therapy products are in scope. Calls for risk assessment of single-use manufacturing components |
Separately from the quality guidelines, in May 2023 ICH set up the Cell and Gene Therapy Discussion Group (CGTDG). Made up of experts drawn from regulators, pharmaceutical industry organisations and Standing Observers, it issued recommendations on future ATMP-related guidelines in November 2025 Sourced. The Q5E annex in the table above grew out of these recommendations.
The draft Q3E calls for a quality risk assessment of single-use and multi-use manufacturing components and systems, primary packaging and delivery device components, and for the results of extractables and leachables studies to be included in the application Sourced. The applicant is the drug company, but the underlying data come from material information on culture bags and tubing. Once the guideline is final and regulators adopt it, the amount and format of data expected from component makers are likely to converge. Our explainers on single-use systems and on QbD and CMC help show how these pieces connect.
4. How far its influence reaches (powers and geography)
| Aspect | What ICH has | What it does not have |
|---|---|---|
| Powers | Drafting and adopting guidelines. Publishing each regulator's implementation status (updated twice a year). Setting the conditions of membership (the Q1 series on stability testing, Q7 on GMP for active pharmaceutical ingredients and E6 on clinical trials must be implemented on joining) | Powers of approval, inspection or sanction. Any power to make companies follow the guidelines directly |
| Geography | 19 regulatory members (including the U.S., the EU, Japan, China, South Korea, Canada, Switzerland, the UK and Brazil). In Switzerland, guidelines apply automatically once they reach Step 4 | Any power to make regulators implement on the same timetable. Any effect in countries that are not members |
| Industry involvement | Industry bodies are members too (the founding industry members are EFPIA in Europe, the Japan Pharmaceutical Manufacturers Association (JPMA) and PhRMA in the U.S.) | Membership for individual companies (only industry bodies can join) |
| Scale | 25 members and 43 observers (June 2026). A 2026 budget of about CHF 18.5 million, most of it for MedDRA | The number of secretariat staff is not stated in the sources used for this article |
Of the 2026 budget total of CHF 18.497 million, CHF 13.765 million is for costs related to MedDRA, the medical terminology for regulatory activities, which pays for itself through subscription fees Sourced. The cost of ICH's own activities, including guideline development, comes to CHF 6.233 million when secretariat administration, meetings, programmes, global cooperation and working group support are added together Our calculation. ICH's influence comes not from the size of its budget but from member regulators turning its guidelines into their own rules.
5. Companies and organisations involved
Organisations in ICH, and where they touch this series
| Organisation | Position in ICH | Relevance to cell culture technology |
|---|---|---|
| FDA / EC, Europe / MHLW and PMDA | Founding regulatory members | Covered in this series' institution profiles (FDA, EMA, MHLW and PMDA). They bring ICH guidelines into their national or regional review standards |
| USP, PIC/S and EDQM | Observers (international organisations regulated or affected by ICH guidelines) | USP has its own institution profile in this series. PIC/S supports implementation of the ICH quality guidelines by training inspectors, and ICH contributed CHF 150,000 to it in 2025 |
| EFPIA, JPMA, PhRMA, BIO and others | Industry members (EFPIA, JPMA and PhRMA are founding members) | Drug and biotech companies take part in writing guidelines through their industry bodies |
| FUJIFILM Wako Pure Chemical | Not an ICH participant (a user of the guidelines) | Says on its website that it makes compounds for cell culture used in manufacturing regenerative medicine products in compliance with ICH Q7 (GMP for active pharmaceutical ingredients) (see our FUJIFILM Wako Pure Chemical profile) |
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| How to demonstrate comparability after a change to an ATMP manufacturing process is expected to become a shared international rule around 2028 | The Q5E Annex concept paper (endorsed 2 June 2026) plans publication of the draft (Step 2) in August 2027 and final adoption (Step 4) in January to February 2028 | Not yet confirmed |
| Once the extractables and leachables guideline (Q3E) is final, the data expected from suppliers of single-use components will become more uniform | The Q3E draft was published on 1 August 2025 and work continues after public consultation. The draft covers cell and gene therapy products and single-use manufacturing components | Inference |
| In cell and gene therapy, more new guideline topics will follow the Q5E annex | In November 2025 the CGTDG issued recommendations on future ATMP-related guidelines, setting out priority areas | Inference |
7. Glossary
- Steps 1 to 5
- The stages of ICH guideline development. A draft is published for consultation at Step 2, the final version is adopted at Step 4, and regulators implement it at Step 5.
- Regulatory member / observer
- Members are the regulators and industry bodies with a vote. Observers are regulators and international organisations that take part in discussions.
- Cell substrate
- A cell line used to produce a biologic. Q5D sets out how its origin, characteristics and cell banks are controlled.
- Comparability
- Showing that a change to the manufacturing process has had no adverse effect on quality, safety or efficacy.
- Extractables and leachables
- Substances that can be drawn out of manufacturing components or containers under test conditions (extractables), and those that actually migrate into the product (leachables).
- MedDRA
- A medical terminology for regulatory use developed by ICH. It is used worldwide, for example in reporting adverse reactions, and is funded by subscription fees.
8. References
- ICH Members & Observers: 3 founding regulatory members, 3 founding industry members, 2 standing regulatory members, 14 regulatory members and 3 industry members, and the list of observers. https://www.ich.org/page/members-observers
- ICH History: launch in Brussels in April 1990, and incorporation as an association under Swiss law on 23 October 2015. https://www.ich.org/page/history
- ICH Secretariat: the secretariat is in Geneva, Switzerland. https://www.ich.org/page/secretariat
- ICH Press Release: ICH Assembly Meeting, Rio de Janeiro, June 2026 (25 members and 43 observers). https://www.ich.org/pressrelease/press-release-ich-assembly-meeting-rio-de-janeiro-june-2026
- ICH 2025 Annual Report: regulatory members' commitment to implement all guidelines, the Tier 1 to 3 classification, the implementation database updated twice a year, the CHF 150,000 contribution to PIC/S and its training, adoption of the Q5E Annex as a new topic, and publication of the Q3E draft. https://admin.ich.org/sites/default/files/inline-files/2025_Annual_Report_of_the_ICH_Association_0.pdf
- ICH 2026 ICH & MedDRA Combined Budget (approved November 2025; in thousands of CHF). https://admin.ich.org/sites/default/files/inline-files/2026%20ICH%20%26%20MedDRA%20Combined%20Budget.pdf
- ICH Quality Guidelines: stage and date of each guideline, and implementation status by regulator (updated 23 September 2026). https://www.ich.org/page/quality-guidelines
- ICH Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (adopted 1 November 2023): recommendation for adoption at Step 4, scope, and the exclusion of cell therapies. https://database.ich.org/sites/default/files/ICH_Q5A%28R2%29_Guideline_2023_1101.pdf
- ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products (adopted 16 November 2022): scope. https://database.ich.org/sites/default/files/ICH_Q13_Step4_Guideline_2022_1116.pdf
- ICH Q3E Guideline for Extractables and Leachables (Step 2 draft, 1 August 2025): scope, and risk assessment of single-use components. https://database.ich.org/sites/default/files/ICH_Q3E_EWG_Step2_DraftGuideline_2025_0704.pdf
- ICH Final Concept Paper "Q5E Annex: Comparability of ATMPs Subject to Changes in Their Manufacturing Process" (endorsed 2 June 2026): work plan. https://database.ich.org/sites/default/files/ICH_Q5E_Annex_Final_Concept_Paper_2026_0720.pdf
- ICH Reflection Papers: the Cell and Gene Therapy Discussion Group (CGTDG), set up in May 2023, finalised its recommendations in November 2025. https://www.ich.org/page/reflection-papers
- ICH News item "Recommendations for Future Guidelines Related to Advanced Therapy Medicinal Products": the CGTDG is made up of experts from regulators, pharmaceutical industry organisations and Standing Observers. https://www.ich.org/news/recommendations-future-guidelines-related-advanced-therapy-medicinal-products
- FUJIFILM Wako Pure Chemical Product page, "GMP-compliant compounds for cell culture" (in Japanese): control in compliance with ICH Q7 (GMP for active pharmaceutical ingredients), and raw materials for commercial production of regenerative medicine products. https://labchem-wako.fujifilm.com/jp/category/03427.html
9. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Composition of members and observers; founding regulatory members (EC, Europe; FDA; MHLW/PMDA) and industry members (EFPIA, JPMA, PhRMA); USP, PIC/S and EDQM as observers | Sourced | Reference 1 https://www.ich.org/page/members-observers |
| Launched in 1990; became an association under Swiss law on 23 October 2015 | Sourced | Reference 2 https://www.ich.org/page/history |
| The secretariat is in Geneva, Switzerland | Sourced | Reference 3 https://www.ich.org/page/secretariat |
| 25 members and 43 observers (June 2026) | Sourced | Reference 4 https://www.ich.org/pressrelease/press-release-ich-assembly-meeting-rio-de-janeiro-june-2026 |
| Regulatory members commit to implementing all guidelines; guidelines required on joining (Q1 series, Q7, E6); implementation status updated twice a year; the contribution to PIC/S; adoption of the Q5E Annex (May 2025) | Sourced | Reference 5 https://admin.ich.org/sites/default/files/inline-files/2025_Annual_Report_of_the_ICH_Association_0.pdf |
| 2026 budget total of CHF 18.497 million, ICH membership fees of CHF 2.355 million, MedDRA-related costs of CHF 13.765 million | Sourced | Reference 6 https://admin.ich.org/sites/default/files/inline-files/2026%20ICH%20%26%20MedDRA%20Combined%20Budget.pdf |
| Stage and date of each guideline, implementation dates and status of Q5A(R2) by regulator, implementation status of Q12, automatic application in Switzerland | Sourced | Reference 7 https://www.ich.org/page/quality-guidelines |
| Recommendation for adoption by regulators in each region at Step 4; scope of Q5A(R2) (cytokines, antibodies, viral vectors; cell therapies excluded) | Sourced | Reference 8 https://database.ich.org/sites/default/files/ICH_Q5A%28R2%29_Guideline_2023_1101.pdf |
| Scope of Q13 (chemical drugs and therapeutic proteins) | Sourced | Reference 9 https://database.ich.org/sites/default/files/ICH_Q13_Step4_Guideline_2022_1116.pdf |
| Publication date of the Q3E draft, its scope including cell and gene therapy products, and risk assessment of single-use components | Sourced | Reference 10 https://database.ich.org/sites/default/files/ICH_Q3E_EWG_Step2_DraftGuideline_2025_0704.pdf |
| Work plan for the Q5E Annex (Step 2 in August 2027, Step 4 planned for January to February 2028) | Not yet confirmed | Reference 11 https://database.ich.org/sites/default/files/ICH_Q5E_Annex_Final_Concept_Paper_2026_0720.pdf |
| CGTDG set up (May 2023) and recommendations finalised (November 2025) | Sourced | Reference 12 https://www.ich.org/page/reflection-papers |
| Make-up of the CGTDG (experts from regulators, pharmaceutical industry organisations and Standing Observers) | Sourced | Reference 13 https://www.ich.org/news/recommendations-future-guidelines-related-advanced-therapy-medicinal-products |
| FUJIFILM Wako Pure Chemical's compounds for cell culture comply with ICH Q7 | Sourced | Reference 14 https://labchem-wako.fujifilm.com/jp/category/03427.html |
| Breakdown of members (19 regulators, 6 industry bodies), the counts of 12 regulators implementing Q5A(R2) and 4 implementing Q12, ICH's own costs of CHF 6.233 million, and the four types of institution | Our calculation | Our own tally and classification from references 1, 6 and 7 |
| Number of secretariat staff | Not yet confirmed | Not stated in references 1 to 7; this article does not estimate it |
| The Q3E and CGTDG points in the outlook (section 6), and the reading that Q3E will make the data expected from component makers more uniform | Inference | This article's reading of references 10 and 12 |
Last updated 24 September 2026 / Troy Technical
All figures come from the ICH website, guideline texts, budget, annual report and the websites of the companies concerned. Items marked "Inference" are this article's reading of the primary information, not statements by ICH.