European Medicines Agency

What European Medicines Agency does

The European Medicines Agency (EMA) is a decentralised agency of the European Union, established in 1995 and headquartered in Amsterdam, the Netherlands. EMA serves as the EU's central scientific regulator for medicines used in humans and animals, evaluating marketing authorisation applications, monitoring safety throughout each product's lifecycle, and providing scientific advice to medicine developers. Its stakeholders span the pharmaceutical industry (which funds approximately 91.5% of the 2026 €615.5 million budget through application and service fees), patients and healthcare professionals, academic researchers, and over 50 national competent authorities across EU/EEA member states — together contributing roughly 4,000 experts to EMA's committees and working parties.

EMA's core products are regulatory in nature rather than commercial. Scientific evaluation is performed by committees including CHMP (human medicines), CVMP (veterinary medicines), PRAC (pharmacovigilance), COMP (orphan designations), CAT (advanced therapies), PDCO (paediatric) and HMPC (herbal). The agency's platform ecosystem includes EudraVigilance (suspected side-effect reporting), the Clinical Trials Information System, IRIS (scientific procedures), eSubmission, the Product Lifecycle Management Portal, SPOR master data services, the European Shortages Monitoring Platform, and the HMA-EMA Catalogues of Real-World Data Sources and Studies. The PRIME scheme provides enhanced and accelerated regulatory support for priority medicines.

EMA generates no commercial revenue. Income is dominated by fees charged to pharmaceutical companies for marketing authorisation evaluations, pharmacovigilance, scientific advice and inspections, with the balance (around 8.2%) coming from the EU general budget for orphan, paediatric, advanced-therapy, and SME support policies. Approximately €240.4 million of the 2026 budget is paid through to national competent authorities. Decisions and product information are disseminated through the ema.europa.eu portal in 25 EU languages, complemented by committee highlights, the Inside EMA podcast, newsletters, and social media channels.

Name

European Medicines Agency

Legal name

European Medicines Agency

Website

https://ema.europa.eu

Company type

Public

Founded year

1995

Operating status

Operating

Headcount range

1–10 employees

Short description

The European Medicines Agency (EMA) is the EU's decentralised regulatory authority, headquartered in Amsterdam, which evaluates and supervises human and veterinary medicines for the 27 EU member states plus EEA countries, coordinating over 50 national competent authorities and approximately 4,000 scientific experts through a centralised marketing authorisation pathway.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Services

NAICS

Other Scientific and Technical Consulting Services (54169), Other Scientific and Technical Consulting Services (541690)

akta.pro primary industry

Drug Regulators (Human Pharmaceuticals) (HLAJADAA)

akta.pro secondary industries

Health, Pharmaceuticals & Medical Devices Regulatory Cooperation (BPADANAJ), Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI)

Keywords

• Regulatory medicines evaluation
• Marketing authorisation services
• Pharmacovigilance monitoring
• Clinical trial authorisation
• Medicines safety assessment

Headquarters

HQ city

Amsterdam

HQ country

Netherlands

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure

Revenue model

1. Fees from Industry: EMA charges fees to companies for evaluation of marketing authorisation applications, monitoring of medicine safety, scientific advice, inspections, and establishment of maximum residue limits. Approximately €563.2 million from fees and charges in 2026.
2. EU Public Health Contributions: Approximately €50.9 million expected from the European Union to support orphan medicines, paediatric medicines, advanced therapies, and SME support policies.

Distribution channels3 records

Marketing channels6 records

Core offering

The European Medicines Agency (EMA) evaluates and supervises medicines for human and veterinary use within the European Union. It issues marketing authorisation recommendations, monitors medicine safety through pharmacovigilance, and provides scientific advice to pharmaceutical companies throughout the medicine lifecycle.

Product overview

The European Medicines Agency (EMA) is the EU regulatory authority responsible for the evaluation, supervision, and safety monitoring of medicines for human and veterinary use. EMA operates a unified platform ecosystem consisting of multiple interconnected regulatory systems and scientific committees. The core scientific evaluation is conducted through committees including CHMP (Committee for Medicinal Products for Human Use), PRAC (Pharmacovigilance Risk Assessment Committee), and COMP (Committee for Orphan Medicinal Products), which evaluate marketing authorisation applications and monitor medicine safety. Supporting this regulatory work are technology platforms including EudraVigilance for adverse drug reaction reporting, IRIS for scientific and regulatory procedures, the European Shortages Monitoring Platform for medicine supply monitoring, Product Lifecycle Management Portal for product data, SPOR data management for master data, eSubmission for regulatory submissions, and HMA-EMA Catalogues for real-world evidence. The PRIME (Priority Medicines) scheme provides enhanced regulatory support for promising medicines, with new features including regulatory roadmap and product development tracker launched in March 2026. EMA facilitates international collaboration through joint initiatives with FDA, PMDA, Health Canada, and other global regulatory authorities.

Differentiator

Problem solved

Functional benefit

Products and services

• EudraVigilance European database of suspected adverse drug reaction reports containing side effects reported by patients and healthcare professionals in the EU, with interpretive guidance. Used by regulators, healthcare professionals, and patients for medicine safety monitoring.
• EU Clinical Trials Information System Centralised system for managing clinical trials in the EU and EEA, with publicly available information on clinical trials granted or refused permission via the system. Used by pharmaceutical companies, researchers, and regulators.
• IRIS Secure online platform used by pharmaceutical companies for handling product-related scientific and regulatory procedures with EMA, with certain information accessible to all visitors.
• European Shortages Monitoring Platform (ESMP) Platform used by pharmaceutical companies and national competent authorities to gather information about medicine supply and demand in the European Union and European Economic Area.
• Product Lifecycle Management Portal (PLM) Platform used by pharmaceutical companies and regulators for managing medicine-related product data, with read-only access for public visitors.
• SPOR Data Management Services Services used by pharmaceutical companies and regulators for managing medicine-related master data including substance, product, organisation and referential data, with read-only access to all visitors.
• eSubmission Platform used by pharmaceutical companies to submit regulatory information concerning marketing authorisation applications to the national competent authorities and EMA.
• EMA Account Management System used for creating and managing EMA user accounts, which users need for accessing certain services and systems managed by EMA.
• HMA-EMA Catalogues of Real-World Data Sources and Studies Catalogues that help regulators, pharmaceutical companies, and researchers identify suitable data sources to address specific research questions, and enable researchers to register observational studies.
• CHMP (Committee for Medicinal Products for Human Use) EMA's main scientific committee responsible for human medicines that evaluates marketing authorisation applications and provides recommendations to the European Commission.
• PRAC (Pharmacovigilance Risk Assessment Committee) EMA committee responsible for assessing and monitoring the safety of human medicines, including adverse drug reaction reporting and risk management.
• COMP (Committee for Orphan Medicinal Products) EMA committee responsible for evaluating applications for orphan drug designation to encourage development of medicines for rare diseases.
• PRIME Scheme EMA's Priority Medicines scheme that provides enhanced interaction and early support to medicine developers to optimise generation of robust data and enable accelerated assessment of promising medicines.

Quantifiable outcome

• 104 medicines recommended for marketing authorisation in 2025
• +2 more outcomes

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

25 partnerships are on record, tiered minor and core.

• IncyteminorStrategic or Co-development Partner · 26 June 2026EMA CHMP issued positive opinion for Opzelura (ruxolitinib) cream for moderate atopic dermatitis, potentially becoming first steroid-free topical JAK inhibitor approved for this indication in EU.
• Acadia PharmaceuticalsminorStrategic or Co-development Partner · 26 June 2026EMA CHMP recommended approval of Daybue for Rett syndrome neurobehavioral symptoms, potentially becoming first treatment permitted in Europe for this indication.
• Eli LillyminorStrategic or Co-development Partner · 26 June 2026EMA issued positive opinion for Eli Lilly's Jaypirca for chronic lymphocytic leukemia, expected to lead to European Commission approval within two months.
• AstraZeneca/Daiichi Sankyo (Datroway)minorStrategic or Co-development Partner · 26 June 2026EMA CHMP recommended Datroway for triple negative breast cancer with 43% reduction in disease progression or death risk based on TROPION-Breast02 phase 3 trial.
• MSD (Merck)minorStrategic or Co-development Partner · 26 June 2026European Commission approved KEYTRUDA plus chemotherapy for PD-L1 positive platinum-resistant recurrent ovarian carcinoma, first and only PD-1 inhibitor-based treatment in EU.
• AmgenminorStrategic or Co-development Partner · 26 June 2026EMA called for revocation of marketing authorization for Amgen's Tavneos medication citing data integrity concerns from pivotal Phase 3 ADVOCATE trial.
• MSD (Merck)minorStrategic or Co-development Partner · 25 June 2026European Commission approved MSD's Keytruda plus Padcev combination as neoadjuvant treatment for muscle-invasive bladder cancer, first PD-1 inhibitor plus ADC regimen for this group.
• Korea's Ministry of Food and Drug SafetyminorStrategic or Co-development Partner · 17 June 2026Korea completed its first international joint review of a biopharmaceutical alongside European and global regulators under EMA's OPEN framework, validating Korea's domestic regulatory capabilities following its inclusion in WHO Listed Authorities.
• Zai LabminorStrategic or Co-development Partner · 16 June 2026EMA granted Orphan Drug Designation to Zai Lab's zocilurtatug pelitecan for pulmonary neuroendocrine carcinomas, providing regulatory incentives including potential market exclusivity.
• LongeveronminorStrategic or Co-development Partner · 9 June 2026EMA granted Small or Medium-sized Enterprise (SME) status to Longeveron, providing regulatory benefits including reduced fees, access to scientific advice, and protocol assistance for laromestrocel development.
• SERB PharmaceuticalsminorStrategic or Co-development Partner · 28 May 2026SERB Pharmaceuticals signed agreement to acquire exclusive development and commercialisation rights to Idefirix (imlifidase) for €115 million covering EU, UK, Switzerland, Norway, Iceland, Liechtenstein, and MENA region. EMA reviewing for full marketing authorisation.
• AstraZeneca and Daiichi SankyominorStrategic or Co-development Partner · 26 May 2026EMA CHMP recommended approval of Enhertu for HER2-positive solid tumours, potentially becoming first HER2-directed therapy and antibody drug conjugate with tumour agnostic indication in EU.
• MaaT PharmaminorStrategic or Co-development Partner · 26 May 2026EMA CHMP issued negative trend opinion on MaaT Pharma's MaaT013 (Xervyteg) for acute Graft-versus-Host Disease, with re-examination procedure planned.
• Pierre Fabre LaboratoriesminorStrategic or Co-development Partner · 25 May 2026EMA CHMP issued positive opinion for BRAFTOVI (encorafenib) combination therapy for first-line BRAFV600E-mutant metastatic colorectal cancer with 51% reduction in death risk.
• Regeneron PharmaceuticalsminorStrategic or Co-development Partner · 22 May 2026EMA accepted under Accelerated Assessment the Marketing Authorization Application for Otarmeni, an in vivo gene therapy for OTOF-related hearing loss, already approved in US in April 2026.
• AstraZenecaminorStrategic or Co-development Partner · 22 May 2026EMA issued positive recommendation for AstraZeneca's camizestrant for breast cancer despite FDA rejection, representing regulatory success in European market.
• AmgenminorStrategic or Co-development Partner · 28 March 2026EMA CHMP issued positive opinion for Amgen's tarlatamab (Imdelltra) as first-in-class DLL3-directed T-cell engager for relapsed extensive-stage small cell lung cancer.
• Bavarian NordicminorStrategic or Co-development Partner · 27 March 2026EMA reviewing Bavarian Nordic's data submission to extend approval of MVA-BN mpox and smallpox vaccine to children aged 2-11 years, with Phase 2 trial data from Democratic Republic of Congo and Uganda.
• Johnson & JohnsonminorStrategic or Co-development Partner · 27 March 2026EMA approved label variation for DARZALEX (daratumumab) enabling patient self-administration from the fifth dose, the first oncology injectable approved for self-administration in Europe.
• SanofiminorStrategic or Co-development Partner · 27 March 2026EMA CHMP issued positive opinion for Sanofi's Sarclisa (isatuximab) subcutaneous formulation for multiple myeloma, potentially becoming first anticancer treatment available through on-body injector in EU.
• PfizerminorStrategic or Co-development Partner · 27 March 2026EMA CHMP recommended expansion of HYMPAVZI (marstacimab) approval for hemophilia A or B patients with inhibitors, offering once-weekly subcutaneous administration without routine laboratory monitoring.
• U.S. Food and Drug Administration (FDA)coreStrategic or Co-development Partner · 14 January 2026EMA and FDA established joint AI principles for drug development in January 2026, marking the first dedicated AI cluster between the agencies. Collaboration aims to reduce regulatory divergence between EU and US markets, accelerate AI adoption in medicine development while ensuring patient safety.
• European CommissioncoreStrategic or Co-development PartnerThe European Commission is a core partner that takes binding decisions based on EMA's scientific recommendations for marketing authorizations across the EU. The Commission implements EMA's regulatory framework and coordinates broader EU health policy.
• National Competent Authorities (50+ EU/EEA authorities)coreStrategic or Co-development PartnerNational authorities supply thousands of European experts to participate in EMA's scientific committees, working parties, and assessment teams. They implement EMA decisions within their countries and contribute to the unique coordinated regulatory network.
• World Health Organization (WHO)minorStrategic or Co-development PartnerEMA collaborates with WHO on various regulatory matters including emergency response coordination (e.g., Ebola outbreak response, vaccine confidence advisory group), international regulatory harmonization, and joint reviews.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• U.S. Food and Drug Administration (FDA): Direct peer — FDA is the U.S. federal medicines regulator with comparable mandate (drug/biologic/device evaluation, pharmacovigilance, advisory committees). EMA and FDA explicitly coordinate via January 2026 joint AI principles cluster, making them the closest 1:1 peer globally.
• Medicines and Healthcare products Regulatory Agency (MHRA): Direct peer — MHRA is the UK's standalone drug and medical devices regulator, formerly part of the EMA network pre-Brexit; today it operates a comparable national centralized authorization procedure for the UK market with parallel scientific advisory committees.
• Pharmaceuticals and Medical Devices Agency (PMDA): Direct peer — PMDA is Japan's centralized drug and medical device regulator running scientific review, consultation, and pharmacovigilance functions structurally analogous to EMA's CHMP/PRAC model.
• Health Canada: Direct peer — Health Canada performs federal scientific evaluation and authorization of human and veterinary drugs with similar committee-based assessment, biomanufacturing oversight, and post-market surveillance.
• National Medical Products Administration (NMPA): Direct peer — China's national regulator for drugs and medical devices, offering analogous marketing authorization, clinical trial oversight, and pharmacovigilance functions for the world's second-largest pharma market.
• Therapeutic Goods Administration (TGA): Direct peer — Australia's national regulator for therapeutic goods, performing scientific evaluation, registration, and post-market monitoring across prescription medicines and biologicals under a comparable statutory framework.

Regional players

• European Directorate for the Quality of Medicines (EDQM): Regional peer — Council of Europe body operating the CEP procedure for active substance certification and European Pharmacopoeia standards; sits alongside EMA in the European regulatory ecosystem with overlapping quality/scientific remit.
• Swissmedic: Regional peer — Switzerland's therapeutic products regulator, geographically external to EU/EEA but tightly linked to EMA procedures via bilateral mutual-recognition agreements for marketing authorization.

Emerging players

• WHO Prequalification of Medicines Programme: Emerging/global player — UN-level medicines assessment service focused on priority diseases and vaccines for low-/middle-income markets; less binding than national regulators but increasingly coordinated with EMA via joint reviews.

Others

• International Council for Harmonisation (ICH): Others — ICH is not a regulator but a multilateral forum where EMA, FDA, PMDA, Health Canada and others co-develop harmonized technical guidelines (e.g., for AI/ML in drug development); it is a key ecosystem participant shaping how EMA operates.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/user/emainfo
• LinkedInlinkedin.com/company/european-medicines-agency
• Xx.com/EMA_News

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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M&A

Investments1 record

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Frequently asked questions about European Medicines Agency