Heads of Medicines Agencies

What Heads of Medicines Agencies does

Heads of Medicines Agencies (HMA) is a statutory regulatory coordination network, not a commercial enterprise. Established in November 2005 and anchored in EU pharmaceutical legislation (Directive 2004/27/EC, Directive 2004/28/EC, and Regulation (EU) 2019/6), HMA comprises the heads of the National Competent Authorities (NCAs) responsible for the regulation of medicinal products for human and veterinary use across the European Economic Area. It operates through two coordination groups — CMDh for human medicines and CMDv for veterinary medicines — which examine questions on marketing authorisations under mutual recognition (MRP) and decentralised procedures (DCP), and through topic-specific Working Groups reporting to a Management Group and supported by a Permanent Secretariat.

HMA's substantive mandate is to coordinate the European Medicines Regulatory Network alongside the European Medicines Agency (EMA) and the European Commission, addressing strategic issues such as exchange of information, IT developments, sharing of best practices, work-sharing arrangements, and the development and consistency of the regulatory system. Its core deliverables are procedural coordination, strategic planning documents (such as the CMDh Multi-annual Workplan to 2028 and the EMANS strategy to 2028), regulatory guidance and templates, and communications including the official HMA Newsletter launched in April 2025. The website is hosted by BfArM in Bonn, Germany.

The entity has no commercial revenue model. It does not develop or sell products or technologies, has no commercial pricing or pricing disclosure, and is funded by EU member state NCAs. There are no subsidiaries, no parent company, no funding rounds, no M&A activity, and no app, API, or SDK surface. Accordingly, HMA is functionally a public-sector regulator-coordination utility whose outputs are consumed by NCAs, EMA, the European Commission, and — as a secondary audience — pharmaceutical industry stakeholders seeking procedural transparency across European medicines regulation.

Name

Heads of Medicines Agencies

Legal name

Heads of Medicines Agencies

Website

https://hma.eu

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

1–10 employees

Short description

Heads of Medicines Agencies (HMA) is a European Economic Area regulatory coordination network of National Competent Authorities that operates CMDh and CMDv to coordinate mutual recognition and decentralised procedures for human and veterinary medicines, in cooperation with EMA and the European Commission.

Ownership category

akta.pro rank

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Others

Distribution channels1 record

Marketing channels2 records

Core offering

Heads of Medicines Agencies (HMA) is a network of the heads of the National Competent Authorities (NCAs) responsible for regulating medicinal products for human and veterinary use in the European Economic Area. It coordinates mutual recognition (MRP) and decentralised (DCP) procedures for cross-border marketing authorisations through its two coordination groups, CMDh (human) and CMDv (veterinary), and cooperates with the European Medicines Agency and the European Commission in operating the European medicines regulatory network. HMA addresses strategic issues such as the exchange of information, IT developments, sharing of best practices, and work-sharing arrangements across member state authorities.

Product overview

Heads of Medicines Agencies (HMA) is a network of National Competent Authorities responsible for regulating medicinal products for human and veterinary use in the European Economic Area. The organization does not offer commercial products; instead, it provides regulatory coordination services through two primary bodies: CMDh (for human medicines) and CMDv (for veterinary medicines), which facilitate mutual recognition and decentralised procedures. HMA publishes strategic workplans and newsletters to communicate regulatory developments across the European medicines regulatory network, cooperating with the European Medicines Agency (EMA) and European Commission.

Differentiator

Problem solved

Functional benefit

Products and services

• CMDh - Coordination Group for Mutual Recognition and Decentralised Procedures (Human) CMDh coordinates mutual recognition procedures (MRP) and decentralised procedures (DCP) for human medicinal products across EU Member States. It examines questions relating to marketing authorisations and pharmacovigilance, addresses disagreements between member states in Day 60/90 of DCP, and develops procedural guidance for applicants. The service is for National Competent Authorities and pharmaceutical industry applicants seeking marketing authorisation in multiple EU member states.
• CMDv - Coordination Group for Mutual Recognition and Decentralised Procedures (Veterinary) CMDv examines questions concerning marketing authorisation of veterinary medicinal products in two or more Member States under mutual recognition procedures (MRP) or decentralised procedures (DCP). It facilitates agreement among member states on veterinary medicinal product authorisations and develops procedural guidance for veterinary applicants. The service is for National Competent Authorities and pharmaceutical industry applicants seeking veterinary marketing authorisation across the EEA.
• European Medicines Regulatory Network (EMRN) Coordination HMA's overarching coordination service operates the European medicines regulatory network together with the EMA and the European Commission. It addresses key strategic issues including exchange of information, IT developments, sharing of best practices, and the development, co-ordination and consistency of the European medicines regulatory system. The service also oversees work-sharing arrangements among member state authorities.
• HMA Official Newsletter The official HMA Newsletter publishes regulatory updates, expert insights, and strategic developments across the European regulatory network. It is distributed to subscribers via email and is publicly accessible on the HMA website, serving NCAs, the EMA, the European Commission, and pharmaceutical industry stakeholders.

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Four partnerships are on record, tiered core.

• European Medicines Agency (EMA)coreStrategic or Co-development PartnerHMA cooperates with EMA in the operation of the European medicines regulatory network. EMA provides the secretariat for both CMDh and CMDv coordination groups. The partnership involves operation of the European Medicines Regulatory Network (EMRN) for statutory and voluntary regulatory activities.
• European CommissioncoreStrategic or Co-development PartnerHMA cooperates with the European Commission in the operation of the European medicines regulatory network. The Commission participates as an observer in CMDh meetings and is involved in regulatory governance.
• National Competent Authorities (NCAs)coreOthersHMA is a network of the heads of National Competent Authorities whose organisations are responsible for regulation of medicinal products for human and veterinary use in the European Economic Area. Member agencies provide high-quality professional and scientific resources to all areas of medicines regulation.
• BfArM (Federal Institute for Drugs and Medical Devices, Germany)coreOthersBfArM hosts the HMA website and provides content management services. The website is hosted by BfArM at D-53175 Bonn, Germany.

Scale indicators1 record

Recent moves5 records

Expansion highlights4 records

Market position

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/hma-eu

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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M&A

Investments

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