HMA (Heads of Medicines Agencies)
Who runs the European medicines network?
In one sentence
The HMA is the network of the heads of Europe's national medicines agencies, which shares the regulatory work with the European Medicines Agency.
It is a network, not an agency: no building of its own, a Management Group of national heads, a Permanent Secretariat of advisers seconded from six agencies, and working groups beside the European Medicines Agency (EMA) and the Commission. Its legal arm is the CMDh, the coordination group for medicines authorised nationally, safety decisions included.
Where it sits
- The networkThe European Commission, the EMA and the national agencies
- SteeringManagement Group of national heads, with the presidency of the Council of the European Union (EU)
- NetworkHMA: the heads of the agencies of 31 countries, human and veterinary
- Legal armCMDh, one representative per Member StateSafety decisions for nationally authorised medicines
Think of it like this
Think of a league with no club of its own. The managers of every national team meet, agree the rulebook and share the scouting, while the matches are still played at home.
Key insights
The HMA is the heads of the national competent authorities for human and veterinary medicines in the European Economic Area. It cooperates with the EMA and the Commission, calls itself a unique model for work-sharing, and is run by a Management Group, a Permanent Secretariat of advisers from six agencies, and working groups. Chapter 1 tells how it formed.
Medicines authorised by the Member States rather than by Brussels answer to a coordination group written into the directive: one representative per Member State, three-year terms, the EMA as secretariat. It settles disputes in mutual recognition procedures, examines the pharmacovigilance of national products and keeps the list for harmonised product information.
When the Pharmacovigilance Risk Assessment Committee (PRAC) recommends action on a nationally authorised medicine, the CMDh has 30 days to reach a position. By consensus it binds every Member State; the holder then files the variation on the agreed timetable. Chapter 2 shows who acts on what.
Every five years the HMA and the EMA write a joint strategy for the network; the one to 2028 was adopted in March 2025. The HMA also runs the Clinical Trials Coordination Group, the EU Innovation Network, a joint audit programme with the EMA and a benchmarking group for the agencies.
Jump to: 1 Three moments 2 Your product, their table 3 What the network adds to the law 4 Test yourself
Chapter 1
Which three moments made the HMA what it is?
Pick a year. Each turned a meeting into part of the system.
The heads of agencies meet
In 1995 the national agencies set up a Mutual Recognition Facilitation Group to make the new mutual recognition procedure work. In 1996 the heads of the agencies for human medicines held their first meeting; the veterinary heads followed in 1997, and from 2000 the two met together.
The meetings produced things. In 2002 the heads and the EMA wrote a European Risk Management Strategy, the network’s first joint plan for medicine safety, before the network itself had a name.
What it left behind: the habit of agreeing in a room what no law yet required.
A coordination group with legal status
In 2004 the human and veterinary heads unified their groups: the HMA was formally established, with a Management Group endorsed under the Irish Presidency and a Permanent Secretariat. In November 2005 the CMDh began work, replacing the informal facilitation group after ten years; Directive 2004/27/EC had written it into the law for any question about a medicine authorised in two or more Member States.
Article 27 gives it one representative per Member State, appointed for three years, with the EMA as secretariat. Its first job was to solve disagreements between Member States on potential serious risk to public health in mutual recognition and decentralised procedures.
What it left behind: a network with a legal arm, and a seat for Brussels’ agency at its table.
The safety job arrives
Directive 2010/84/EU, applied from 2012, extended the CMDh’s task substantially. For medicines authorised by the Member States it now examines the pharmacovigilance questions the directive lists: the single assessment of periodic safety update reports, the outcome of safety referrals and of post-authorisation safety studies. In each the CMDh takes a position within 30 days of the report of the Pharmacovigilance Risk Assessment Committee (PRAC) and, by consensus, binds the Member States.
The network kept writing its strategy with the EMA: a joint strategy to 2020 in 2016, one to 2025, and in March 2025 the European medicines agencies network strategy to 2028.
What it left behind: a second safety table beside the Commission’s, for the medicines that never went to Brussels.
Chapter 2
Your product, their table
A safety matter has come up with your medicine. Two questions decide which table acts on it: how was it authorised, and what kind of matter is it? Pick a cell.
Or it is not a safety matter yet: or
Once a centrally authorised medicine is in scope, the HMA’s table does not decide. The Pharmacovigilance Risk Assessment Committee (PRAC) assesses, the Committee for Medicinal Products for Human Use (CHMP) gives the opinion, and the Commission issues the decision to all Member States. Regulation (EC) No 726/2004, Article 10; Directive 2001/83/EC, Article 107e(1)(b)
A referral that touches only nationally authorised medicines ends at the CMDh. Within 30 days of the PRAC’s recommendation it reaches a position on keeping, varying, suspending or revoking the authorisations, with a timetable; by consensus, the Member States must act on it. Directive 2001/83/EC, Article 107k(1) and (2)
For a substance authorised in several Member States and nowhere centrally, the CMDh appoints the Member State that writes the single assessment of the periodic safety update reports, within 60 days. The PRAC reports, and the CMDh takes its position within 30 days. Directive 2001/83/EC, Articles 107e(1)(a) and 107g(1)
A mutual recognition or decentralised application runs between a Reference Member State and the Concerned Member States. If they disagree on a potential serious risk to public health, the CMDh is where the disagreement is examined. Directive 2001/83/EC, Article 27(1)(a); HMA, CMDh
Clinical trials have no coordination group in the directive, so the HMA made one: the Clinical Trials Coordination Group (CTCG), experts nominated by every national agency, with the EMA supporting its secretariat and the Commission observing. HMA, Clinical Trials Coordination Group
A coordination group shall be set up for the following purposes: the examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States; the examination of questions related to the pharmacovigilance of medicinal products authorised by the Member States.
Directive 2001/83/EC, Article 27(1), shortened: the CMDh’s charter
The same article makes the group rely on the PRAC’s assessment and gives its secretariat to the EMA. The HMA coordinates the group; the law gives it the vote.
Chapter 3
What does the network add to the law?
The directive sets the floor. Five places where the HMA built on it.
| The law | The network | |
|---|---|---|
| A national medicine’s safety | Each Member State decides on the authorisations it granted | One position at the CMDh, 30 days after the PRAC, that all Member States implement |
| A periodic report in many countries | A single assessment, by one Member State when nothing is centrally authorised | The CMDh picks that Member State, minding who was Reference Member State |
| A dispute between states | The coordination group examines it | The CMDh aims to solve it on the grounds of potential serious risk to public health |
| Clinical trials, audits, training | Nothing on who coordinates the agencies | The Clinical Trials Coordination Group, a joint audit programme with the EMA, a training centre, a benchmarking group |
| Where the network is going | Nothing | A five-year strategy written with the EMA, the latest to 2028, adopted March 2025 |
Show the legal references
- Safety of national medicines: Directive 2001/83/EC, Articles 107g(1) and (2), 107k(1) and (2), 107q(2).
- Periodic reports: Directive 2001/83/EC, Article 107e(1).
- Disputes: Directive 2001/83/EC, Article 27(1)(a); HMA, CMDh page.
- Working groups: HMA, Working Groups; HMA, Clinical Trials Coordination Group.
- Strategy: EMA, European medicines agencies network strategy.
The law created a group and a secretariat; the heads of agencies made it a network with a strategy.
The facts, in one place
| What it is | A network of the heads of the national competent authorities for human and veterinary medicines in the European Economic Area, working with the EMA and the Commission. |
|---|---|
| Since | 1996, the first meeting of the heads of agencies; formally established in 2004 when the human and veterinary heads unified. |
| Who decides | A Management Group of national heads, with the EU Council presidency at the table; a Permanent Secretariat of advisers from six agencies. |
| Seat | None of its own; the secretariat is seconded staff, hosted in 2019 at the Paul-Ehrlich-Institut, Langen. |
| Legal arm | The CMDh under Article 27 of the directive, at work since November 2005: one representative per Member State, three-year terms, secretariat by the EMA. |
| Working groups | Among them the Clinical Trials Coordination Group, the EU Innovation Network, the EU Network Training Centre, the HMA/EMA Joint Audit Programme and the enforcement officers. |
| Strategy | The European medicines agencies network strategy to 2028, adopted with the EMA in March 2025. |
Don’t confuse it with: the EMA
HMA
The network
- Is: the heads of the national agencies, meeting with a secretariat of seconded advisers
- Decides: through the CMDh, for medicines the Member States authorised
- Example: the CMDh takes a position on a generic sold in twelve countries
EMA
The agency
- Is: an EU agency with its own staff, committees and building
- Decides: gives the opinion on centrally authorised medicines, which the Commission turns into a decision
- Example: provides the CMDh’s secretariat and co-writes the network strategy
Chapter 4
Test yourself
Myth or Truth? Pick an answer to see the explanation.
“The HMA is an EU agency with its own staff.”
It is a network of the heads of the national agencies. Its secretariat is a team of advisers seconded from six agencies, and the directive gives the CMDh’s secretariat to the EMA.
“A PRAC recommendation on a nationally authorised medicine goes to the CMDh, which has 30 days to take a position.”
Articles 107g and 107k of the directive give the coordination group 30 days from the PRAC’s report or recommendation to reach its position, which by consensus binds the Member States.
Sources (10)
- HMA: About HMA
- HMA: Structure, Management Group and Permanent Secretariat
- HMA: Protecting and promoting public and animal health in Europe, leaflet, March 2019 (PDF)
- HMA: Working Groups
- HMA: Clinical Trials Coordination Group
- HMA: CMDh
- HMA: Medicines approval system
- EMA: European medicines agencies network strategy (EMANS)
- Directive 2001/83/EC, consolidated text (EUR-Lex)
- Regulation (EC) No 726/2004, consolidated text (EUR-Lex)
Last reviewed against these 10 sources. Every page is reviewed at least every six months.
