Heads of Medicines Agencies

Heads of Medicines Agencies
Predecessor	Heads of Agencies
Formation	1996;23 years ago
Type	Governmental organization
Purpose	Cooperation on the regulation of pharmaceutical drugs
Region served	European Economic Area
Website	www.hma.eu

Last updated November 10, 2019

The Heads of Medicines Agencies (HMA) is a network of both the human and veterinary medicines agencies of the European Economic Area.^[1]

The European Economic Area (EEA), which was established via the EEA Agreement in 1992, is an international agreement which enables the extension of the European Union (EU)'s single market to non-EU member parties. The EEA links the EU member states and three European Free Trade Association (EFTA) states into an internal market governed by the same basic rules. These rules aim to enable free movement of labour, goods, services, and capital within the European Single Market, including the freedom to choose residence in any country within this area. The EEA was established on 1 January 1994 upon entry into force of the EEA Agreement. The contracting parties are the EU, its member states, and three EFTA member states.

The HMA co-operates with the European Medicines Agency and the European Commission (Directorate-General for Health and Food Safety) in the operation of the European medicines regulatory system. The network provides a forum for the co-ordination and the exchange of views and proposals on issues concerning the European regulatory system and the role of the national authorities within that system.

The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).

The European Commission (EC) is the executive branch of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU. Commissioners swear an oath at the European Court of Justice in Luxembourg City, pledging to respect the treaties and to be completely independent in carrying out their duties during their mandate. The Commissioners are proposed by the Council of the European Union, on the basis of suggestions made by the national governments, and then appointed by the European Council after the approval of the European Parliament. It is common, although not a formal requirement, that the commissioners have previously held senior political positions, such as being a member of the European Parliament or a government minister.

The Directorate-General for Health and Food Safety, until 2014 known as the Directorate-General for Health and Consumers, is a Directorate-General of the European Commission. The DG is responsible for the implementation of European Union laws on the safety of food and other products, on consumers' rights and on the protection of people's health. In 2006, DG Sanco launched the public Health-EU portal to provide European citizens with easy access to comprehensive information on Public Health initiatives and programmes at EU level.

The HMA, initially known as the Heads of Agencies, was established in 1995 with a first full meeting taking place in Amsterdam in February 1996. Initially the network comprised only agencies responsible for the regulation of medicines for human use. In February 1998, a parallel group bringing together the heads of agencies responsible for medicines for veterinary use held its first meeting. The two groups started organising joint meetings in 2000 and since 2004 these activities have been integrated under the umbrella of the HMA.

Membership

The HMA comprises 46 national competent authorities responsible for the regulation of human and/or veterinary medicines. These 46 national authorities represent the 28 EU member states as well as the three additional European Economic Area members, Iceland, Liechtenstein and Norway.

Of the 46 NCAs, 15 have responsibility only for human medicines; 14 are purely veterinary agencies; 17 are joint veterinary and human agencies; and some veterinary agencies are integrated with their respective national food safety agencies or respective ministries. Some have responsibility for pricing and reimbursement of human medicines. 22 have joint responsibility for medicines and medical devices. All are accountable to their national governments.

Together with the European Medicines Agency and the European Commission, these national authorities form the European medicines regulatory system.

Main activities

Medicines can be authorised in Europe through a number of ways:

The centralised procedure, which is the responsibility of the European Medicines Agency
National procedures, which are the responsibility of the national authority of each country
Non-centralised procedures, co-ordinated by the HMA:^[1]
- The decentralised procedure
- Mutual-recognition procedures.

The initial focus of the network in 1995 was the operation of a Mutual Recognition Facilitation Group which was given full legal status in 2003 as the HMA mandated Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMD). In 2012, new European pharmacovigilance legislation added to the role and decision-making powers of the CMD in respect of human medicines.

Over the years, the HMA has added to its coordination activities to include clinical trials authorisation, worksharing of safety aspects, pediatric indications, interpretation of legal provisions and product testing. It has also established a number of shared initiatives across the network which has resulted in Europe-wide projects concerning IT infrastructure, benchmarking, training programs and communication policy. These projects are intended to bring efficiencies and greater consistency to the European medicines regulatory system.

Operations

The HMA is based on a model of cooperation and worksharing across statutory as well as voluntary regulatory activities. The network does not have a permanent executive or head office. However a HMA member agency is requested to support the network by providing professional and scientific resources.

The Management Group, consisting of a number of national heads, co-ordinates and facilitates the operation of the HMA and also supervises the work of the HMA Permanent Secretariat.^[2] The HMA PS facilitates and supports the work of the HMA, the HMA MG and the EU presidency by ensuring co-ordination, consistency and continuity of their work and activities and providing the collective memory of HMA.

After the finalisation of a joint HMA/EMA strategy to 2020, in February 2016 the HMA adopted a Multi Annual Work Plan to bring the joint overarching strategy into operation on the HMA level with the involvement of all National Competent Authorities.^[3]

Related Research Articles

The European Space Agencypronunciation (help·info) is an intergovernmental organisation of 22 member states dedicated to the exploration of space. Established in 1975 and headquartered in Paris, ESA has a worldwide staff of about 2,200 in 2018 and an annual budget of about €5.72 billion in 2019.

The Joint Aviation Authorities (JAA) was an associated body of the EASA representing the civil aviation regulatory authorities of a number of European States who had agreed to co-operate in developing and implementing common safety regulatory standards and procedures. It was not a regulatory body, regulation being achieved through the member authorities. It was in existence from 1970 until disbanded in 2009.

Eurojust is an agency of the European Union (EU) dealing with judicial co-operation in criminal matters among agencies of the member states. It is seated in The Hague, Netherlands. Established in 2002, it was created to improve handling of serious cross-border and organised crime by stimulating investigative and prosecutorial co-ordination.

The Veterinary Medicines Directorate (VMD) is an Executive Agency of the Department for Environment, Food and Rural Affairs (Defra) seeking to protect public health, animal health, the environment and promoting animal welfare by assuring the safety, quality and efficacy of veterinary medicines in the United Kingdom.

The European Organisation for the Safety of Air Navigation, commonly known as EUROCONTROL, is an international organisation working to achieve safe and seamless air traffic management across Europe. Founded in 1960, EUROCONTROL currently has 41 member states and is headquartered in Brussels, Belgium, with local sites in Brétigny-sur-Orge, France for its R&D activities, the Institute of Air Navigation Training (IANS) a training centre in Luxembourg, and the Maastricht Upper Area Control Centre (MUAC). The organisation employs approximately two thousand people and operates with an annual budget in excess of half a billion Euro.

In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.

The European Pharmacopoeia is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. It is a published collection of monographs which describe both the individual and general quality standards for ingredients, dosage forms, and methods of analysis for medicines. These standards apply to medicines for both human and veterinary use.

The Medical Products Agency is the government agency in Sweden responsible for regulation and surveillance of the development, manufacturing and sale of medicinal drugs, medical devices and cosmetics.

The 1st Information Operations Command (Land), formerly the Land Information Warfare Activity Information Dominance Center (LIWA/IDC), is an information operations unit under the operational control of U.S. Army Cyber Command (ARCYBER) and headquartered at Fort Belvoir, Virginia.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia. The signatories to the Convention – 38 member states and the European Union (EU) as of October 2018 – are committed to achieving harmonisation of the quality standards for safe medicines throughout the European continent and beyond. The EDQM’s standards are published in the European Pharmacopoeia, which is recognised as a scientific benchmark worldwide and is legally binding in member states.

The Council of European Energy Regulators (CEER) is a non-profit organisation in which Europe’s national energy regulators voluntarily cooperate to protect consumer interests and to facilitate the creation of a single, competitive and sustainable internal market for gas and electricity in Europe.

The European Regulators' Group for Electricity and Gas (ERGEG) is an advisory group to the European Commission on internal energy market issues in Europe. ERGEG was set up by the European Commission to assist the Commission in consolidating a single EU market for electricity and gas. ERGEG’s members are the heads of the national energy regulatory authorities in the EU’s 28 Member States.

The Covenant of Mayors is a European co-operation movement involving local and regional authorities. Signatories of the Covenant of Mayors voluntarily commit to increasing energy efficiency and the use of renewable energy sources on their territories. By their commitment, they support the European Union 20% CO
2 reduction objective to be reached by 2020.

In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company, who is personally responsible for the safety of the human pharmaceutical products marketed by that company in the EU. This function was established in 2004 by article 23 of regulation (EC) No 726/2004. The article establishes that the holder of a marketing authorization for a drug for human use must have a QPPV. When a company submits an application for permission to bring a medicinal product onto the market, the company submits a description of its system for monitoring the safety of the product in actual use and proof that the services of a QPPV are in place.

Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold.

The European Banking Authority (EBA) is a regulatory agency of the European Union headquartered in Paris. Its activities include conducting stress tests on European banks to increase transparency in the European financial system and identifying weaknesses in banks' capital structures. The EBA was established on 1 January 2011, upon which date it inherited all of the tasks and responsibilities of the Committee of European Banking Supervisors (CEBS). After the United Kingdom withdrawal from the European Union referendum the agency has relocated to Paris.

ALDA, the European Association for Local Democracy, is a membership based organisation established in 1999 at the initiative of the Council of Europe's Congress of Local and Regional Authorities. ALDA works on the promotion of good governance and citizen participation at the local level, focusing on activities that facilitate cooperation between local authorities and civil society in the European Union and its Neighbourhood.

Food Safety Agency of the Republic of Azerbaijan is a state institution under the responsibility of the Cabinet of Ministers of the Republic of Azerbaijan established to ensure regulation of food security. Goshgar Tahmazli was appointed to the post of the chairman of the agency by the presidential decree dated December 25, 2017.

References

1 2 Lezotre, Pierre-Louis (2013). "Chapter1-2.1.2.3 Member states". International cooperation, convergence and harmonization of pharmaceutical regulations a global perspective. London: Academic Press. pp. 77–79. ISBN 9780128005699.
↑ "Structure". www.hma.eu. Heads of Medicines Agencies. Retrieved 6 June 2016.
↑ "EU Medicines Agencies Network Strategy to 2020 Heads of Medicines Agencies (HMA) Multi-annual Work Plan" (PDF). 17 February 2016. Retrieved 18 August 2017.

External links

Official website

This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.

[Lezotre_2013-1] 1 2 Lezotre, Pierre-Louis (2013). "Chapter1-2.1.2.3 Member states". International cooperation, convergence and harmonization of pharmaceutical regulations a global perspective. London: Academic Press. pp. 77–79. ISBN 9780128005699.

[2] "Structure". www.hma.eu. Heads of Medicines Agencies. Retrieved 6 June 2016.

[3] "EU Medicines Agencies Network Strategy to 2020 Heads of Medicines Agencies (HMA) Multi-annual Work Plan" (PDF). 17 February 2016. Retrieved 18 August 2017.