INSTITUTION PROFILE / CELL CULTURE TECHNOLOGY
European Medicines Agency (EMA)
The assessor whose verdict shapes approval across the whole EU
EMA is an agency of the European Union. It makes neither cells nor medicines. Its job is to carry out the scientific assessment of medicines to be sold across the EU and recommend whether they should be authorised. Advanced therapy medicinal products (ATMPs), the umbrella term for cell therapies, gene therapies and tissue-engineered products, must go through EMA. But the final decision to allow a product on the market is taken by the European Commission, and manufacturing sites are inspected by the authorities of the member states. This profile looks at how much influence EMA has over cell culture technology, and at how the work is split between EMA, the Commission and the member states.
- EMA 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. EMA in 30 seconds
EMA is a body that assesses and recommends, not one that grants authorisations. EMA itself explains that it has no authority to permit marketing in the member states, and that the European Commission takes a legally binding decision based on EMA's recommendation. That decision is valid in all EU member states and in Iceland, Liechtenstein and Norway Sourced. For ATMPs such as cell therapies, and for medicines made by biotechnology processes such as recombinant DNA technology, this centralised procedure is compulsory Sourced. So any company that wants to sell a cell culture-derived product in the EU, wherever it is based, has to go through EMA's assessment.
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
Within EMA, cell therapies are the specialist territory of the Committee for Advanced Therapies (CAT), set up under the ATMP Regulation (Regulation (EC) No 1394/2007). For each ATMP application, the CAT prepares a draft opinion, and the Committee for Medicinal Products for Human Use (CHMP) then adopts the final opinion Sourced.
| Function | What it involves | Who does it | Relevance to cell culture technology |
|---|---|---|---|
| Centralised assessment of ATMPs | Evaluates marketing authorisation applications for gene therapies, somatic cell therapies and tissue-engineered products. Applications received: 1 in 2022, 4 in 2023, 7 in 2024 and 3 in 2025 | CAT drafts, CHMP gives the opinion, the European Commission decides | CAR-T cells and products made from cultured cells or tissues can win EU authorisation only by this route |
| Centralised assessment of biologics | Medicines made by biotechnology processes such as recombinant DNA technology must also use the centralised procedure | CHMP gives the opinion, the European Commission decides | Also covers antibody drugs and other products made in cell culture |
| ATMP classification | Advises on whether a product in development counts as an ATMP. Classification requests: 51 in 2022, 28 in 2025 | CAT | Settles early in development which rules will apply |
| Certification for SMEs | Certifies quality and non-clinical data for small and medium-sized enterprises developing ATMPs | CAT | Lets smaller companies with limited money and staff have their quality data evaluated before they apply for authorisation |
| GMP (manufacturing control) | GMP guidelines specific to ATMPs were published by the European Commission on 22 November 2017 and apply from 22 May 2018. Inspections are carried out by the national authorities of the member states; EMA coordinates inspections for centrally authorised products | European Commission, national authorities and EMA | Plants outside the EU are generally inspected by the authority of the member state where the EU importer is based (unless a mutual recognition agreement applies) |
| Adoption of ICH guidelines | ICH quality guidelines are adopted as EU scientific guidelines. Q5A(R2), on viral safety of products derived from cell substrates, was implemented on 14 June 2024 | The EU's seat at ICH is "EC, Europe" | Internationally agreed thinking on quality becomes an EU assessment standard |
In a warning issued on 13 March 2025, EMA explained that there are only three legal ways to get an ATMP to patients in the EU: central marketing authorisation through EMA, an authorised clinical trial, and use in a hospital under a special national authorisation (the hospital exemption) Sourced. The hospital exemption is granted country by country, so it lies outside EMA's authority. For a supplier of culture media or equipment, the practical difference is this: customers making commercial products for the whole EU work to EMA's standards, while customers making products in hospitals work to national standards. See also our explainers on GMP and on autologous and allogeneic cell therapies.
4. How far its influence reaches (powers and geography)
| Aspect | What EMA has | What it does not have |
|---|---|---|
| Powers | Scientific assessment of applications and recommendations, advice on ATMP classification, certification of SME data, and coordination of inspections for centrally authorised products | The decision to authorise marketing (the European Commission). The inspections themselves (national authorities). Hospital exemption authorisations (national authorities) |
| Geography | All EU member states plus three EEA countries. Plants making products imported into the EU are subject to inspection even if they are outside the EU (in China, for example) | Any power to decide what may be sold outside the EU and EEA |
| International influence | As "EC, Europe", a founding regulatory member of ICH, the EU brings ICH guidelines into its own guidance | Any power to bind other regulators' approval decisions |
| Scale | 975 staff (end of 2025) and a budget of €600.23 million (2025, covering all activities including veterinary medicines) | Staff and budget devoted to ATMP assessment alone are not given in published sources |
The figure of 975 is our own sum of the headcounts in the annual activity report's staffing tables as of 31 December 2025 (701 temporary agents, 222 contract agents and 52 seconded national experts) Our calculation. Much of the assessment work is done not by EMA staff but by committee members and experts provided by the national authorities, so 975 is not the number of people across the EU involved in assessing ATMPs. ATMP applications are few, just a handful a year (three in 2025), so each one carries a lot of weight Sourced.
5. Companies and organisations involved
In its disclosure, WuXi Biologics (Example 2) describes this as an "EU EMA GMP inspection", but under EU arrangements the inspection itself is carried out by a member state's authority, with EMA coordinating Sourced. The company also discloses that 23 of the 49 regulatory inspections it has undergone since 2017 were by the EMA and FDA, which shows EU regulation reaching all the way into contract manufacturing in China (see our WuXi Biologics and AGC Biologics profiles).
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| The overhaul of EU pharmaceutical law will change the ATMP Regulation and the make-up of EMA's scientific committees. Whether the CAT survives in its current form has not been decided | The European Parliament and the Council reached a political agreement on 11 December 2025. Entry into force is expected during 2026, with a transition period running to 2028, and the package includes targeted amendments to the ATMP Regulation. EMA has begun early engagement with its committees on future ways of working in line with the "proposed committee reform" | Not yet confirmed |
| Companies selling ATMPs in the EU will need to prepare for joint clinical assessments under health technology assessment (HTA) alongside the regulatory review | The EU HTA Regulation has applied since January 2025, and the first products in scope are new active substances for cancer and all ATMPs | Inference |
| How to show comparability after a change to an ATMP manufacturing process will be harmonised across the U.S., Europe and Japan through a new ICH annex, and will become part of EU assessment standards | Adoption of the ICH Q5E Annex (comparability of ATMPs) by regulatory members is planned for February 2028. The EU has brought ICH quality guidelines into CHMP guidance (Q5A(R2) is an example) | Inference |
7. Glossary
- ATMP (advanced therapy medicinal product)
- The collective term for gene therapies, somatic cell therapies and tissue-engineered products, including those combined with a medical device.
- CAT / CHMP
- EMA's scientific committees. The CAT is the specialist committee for ATMPs and prepares draft opinions; the CHMP adopts the final opinion on human medicines in general.
- Centralised procedure
- The route by which the European Commission, on the basis of EMA's assessment, authorises a medicine for the whole EU in a single decision. It is compulsory for ATMPs and biologics.
- Hospital exemption
- An arrangement under which a member state's authority allows an ATMP to be used in a hospital under specific conditions. It is a national authorisation, not an EU-wide approval.
- EEA (European Economic Area)
- The EU member states plus Iceland, Liechtenstein and Norway. Central authorisations are valid across the EEA too.
- HTA (health technology assessment)
- A process for assessing the clinical value of new medicines. In the EU, the HTA Regulation has applied since January 2025.
8. References
- EMA Authorisation of medicines: EMA has no authority to permit marketing and the European Commission takes a legally binding decision; validity in all EU member states and three EEA countries; medicines for which the centralised procedure is compulsory. https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines
- EMA Committee for Advanced Therapies (CAT): its role, and its establishment under Regulation (EC) No 1394/2007. https://www.ema.europa.eu/en/committees/committee-advanced-therapies-cat
- EMA Advanced therapy medicinal products: Overview: the three types of ATMP, combined products and the centralised procedure. https://www.ema.europa.eu/en/human-regulatory-overview/advanced-therapy-medicinal-products-overview
- EMA Annual activity report 2025 (25 June 2026): headquarters address, final 2025 budget of €600.23 million and income breakdown, staffing tables (as of 31 December 2025), numbers of ATMP applications and classification requests, the CAT's role, the HTA Regulation, and preparations for the legislative reform. https://www.ema.europa.eu/en/documents/annual-report/annual-activity-report-2025_en.pdf
- EMA History of EMA: establishment in 1995 and the London years, 1995 to 2019. https://www.ema.europa.eu/en/about-us/history-ema
- EMA Good manufacturing practice: inspections by the national authorities of the member states, inspection of plants outside the EU, mutual recognition agreements, and EMA's coordination of inspections for centrally authorised products. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice
- European Commission EudraLex Volume 4 (Part IV: GMP guidelines specific to ATMPs, published 22 November 2017 and applicable from 22 May 2018). https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
- EMA News item "Unregulated advanced therapy medicinal products pose serious risks to health" (13 March 2025): the three legal routes for getting an ATMP to patients. https://www.ema.europa.eu/en/news/unregulated-advanced-therapy-medicinal-products-pose-serious-risks-health
- EMA Reform of the EU pharmaceutical legislation: political agreement of 11 December 2025, expected entry into force during 2026, a transition period to 2028, and targeted amendments to the ATMP Regulation. https://www.ema.europa.eu/en/about-us/what-we-do/reform-eu-pharmaceutical-legislation
- ICH Quality Guidelines: implementation of Q5A(R2) by EC, Europe on 14 June 2024 (EMA/CHMP/ICH/804363/2022). https://www.ich.org/page/quality-guidelines
- ICH Members & Observers: founding regulatory members (EC, Europe; FDA, United States; MHLW/PMDA, Japan). https://www.ich.org/page/members-observers
- ICH Final Concept Paper "Q5E Annex: Comparability of ATMPs Subject to Changes in Their Manufacturing Process" (endorsed 2 June 2026; Step 4 planned for January to February 2028). https://database.ich.org/sites/default/files/ICH_Q5E_Annex_Final_Concept_Paper_2026_0720.pdf
- EMA Aucatzyl EPAR: marketing authorisation holder Autolus GmbH, conditional marketing authorisation valid throughout the EU granted on 17 July 2025, ATMP. https://www.ema.europa.eu/en/medicines/human/EPAR/aucatzyl
- AGC Biologics Press release "European Commission Approves CAR-T Therapy With Lentiviral Vectors Manufactured by AGC Biologics" (31 July 2025): the Milan site and its tenth approval from the EMA and FDA. https://www.agcbio.com/news/european-commission-approves-car-t-therapy-with-lentiviral-vectors-manufactured-by-agc-biologics
- WuXi Biologics (Cayman) Inc. Interim Results Announcement for the six months ended June 30, 2026: the EU GMP inspection of the Suzhou testing center, EU applications for 19 products from 13 clients, and 49 regulatory inspections since 2017 (23 of them by the EMA and FDA). https://cdn.wuxibiologics.com/en/wp-content/uploads/2026/09/20260923170523480.pdf
9. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| EMA does not grant marketing authorisation; the European Commission takes a legally binding decision. Authorisations are valid in all EU member states and three EEA countries. The centralised procedure is compulsory for ATMPs and biotechnology-derived medicines | Sourced | Reference 1 https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines |
| The CAT's role (draft opinions, classification, certification of SME data) and its establishment under the ATMP Regulation | Sourced | Reference 2 https://www.ema.europa.eu/en/committees/committee-advanced-therapies-cat |
| Types of ATMP (gene therapies, somatic cell therapies, tissue-engineered products and combined products) | Sourced | Reference 3 https://www.ema.europa.eu/en/human-regulatory-overview/advanced-therapy-medicinal-products-overview |
| Headquarters location, budget of €600.23 million (91.4% fees, 8.3% EU budget), staffing figures (701, 222, 52), ATMP applications (2022 to 2025) and classification requests, the scope of the HTA Regulation, and work towards the committee reform | Sourced | Reference 4 https://www.ema.europa.eu/en/documents/annual-report/annual-activity-report-2025_en.pdf |
| Established in 1995; based in London from 1995 to 2019 | Sourced | Reference 5 https://www.ema.europa.eu/en/about-us/history-ema |
| Inspections are carried out by the national authorities, with EMA coordinating for centrally authorised products. Inspection of plants outside the EU and mutual recognition agreements | Sourced | Reference 6 https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice |
| GMP guidelines specific to ATMPs (published 22 November 2017, applicable from 22 May 2018, European Commission) | Sourced | Reference 7 https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en |
| The three legal routes for ATMPs (central authorisation, clinical trials, hospital exemption) | Sourced | Reference 8 https://www.ema.europa.eu/en/news/unregulated-advanced-therapy-medicinal-products-pose-serious-risks-health |
| Political agreement on the legislative reform (11 December 2025), expected entry into force in 2026, transition to 2028, targeted amendments to the ATMP Regulation | Not yet confirmed | Reference 9 https://www.ema.europa.eu/en/about-us/what-we-do/reform-eu-pharmaceutical-legislation |
| EU implementation of Q5A(R2) (14 June 2024) | Sourced | Reference 10 https://www.ich.org/page/quality-guidelines |
| The EU's seat at ICH is the founding regulatory member "EC, Europe" | Sourced | Reference 11 https://www.ich.org/page/members-observers |
| Planned adoption of the ICH Q5E Annex (comparability of ATMPs) | Not yet confirmed | Reference 12 https://database.ich.org/sites/default/files/ICH_Q5E_Annex_Final_Concept_Paper_2026_0720.pdf |
| Authorisation of Aucatzyl (17 July 2025, conditional, Autolus GmbH) | Sourced | Reference 13 https://www.ema.europa.eu/en/medicines/human/EPAR/aucatzyl |
| AGC Biologics' Milan site makes the vectors for Aucatzyl; its tenth approval from the EMA and FDA | Sourced | Reference 14 https://www.agcbio.com/news/european-commission-approves-car-t-therapy-with-lentiviral-vectors-manufactured-by-agc-biologics |
| WuXi Biologics' Suzhou testing center passed an EU GMP inspection; 19 products from 13 clients; 49 inspections (23 by the EMA and FDA) | Sourced | Reference 15 https://cdn.wuxibiologics.com/en/wp-content/uploads/2026/09/20260923170523480.pdf |
| Staff of 975 (sum of 701, 222 and 52), the four types of institution, and the choice of examples in Fig. 2 | Our calculation | Our own sum of the staffing tables in reference 4, and our own classification |
| Whether the CAT will survive the reform in its current form; staff and budget devoted to ATMP assessment alone | Not yet confirmed | Not stated in references 4 and 9; this article does not speculate |
| The HTA and Q5E Annex points in the outlook (section 6) | Inference | This article's reading of references 4, 10 and 12 |
Last updated 24 September 2026 / Troy Technical
All figures come from EMA's website and annual activity report, the European Commission's EudraLex, the ICH website and disclosures by the companies concerned. Items marked "Inference" are this article's reading of the primary information, not statements by EMA.