Strengthening the regulation of medicines through international cooperation
The HPRA is part of European and international regulatory networks that facilitate cooperation and enable the sharing of resources and expertise, helping to ensure more effective and efficient regulation.
European medicines regulatory network
The European medicines regulatory network is a partnership between the European Medicines Agency (EMA), the European Commission, and the national medicines regulatory authorities of 30 countries — the 27 EU Member States, plus Norway, Iceland, and Liechtenstein.
Working together allows the network to pool resources and expertise, speed up the exchange of information on important issues and reduce administrative burden. The collective approach ensures that medicines meet high standards of quality, safety, and efficacy, while also supporting efficiency so that medicines can reach patients faster.
The network is supported by a pool of over 4,000 experts from medicines authorities across Europe, including the HPRA. Their expertise and contributions provide the network with high‑quality scientific advice and enable the assessment and safety monitoring of 500,000 medicines in Europe.
European Medicines Agency
The European Medicines Agency (EMA) was established in 1995 to ensure the best use of scientific resources across Europe for the evaluation, supervision and safety monitoring of medicines.
Thousands of experts from national medicines authorities, including the HPRA, carry out the EMA’s scientific work by contributing to its committees, working parties, advisory groups, and other ad hoc groups, or as part of the assessment teams that evaluate medicines. These experts are nominated by national authorities based on their scientific expertise or experience.
The EMA has seven committees that carry out its scientific assessments of medicines. Each committee consists of at least one representative from each member country. HPRA experts act as the representatives from Ireland on each committee.
Example of EMA committees include the following:
The Committee for Medicinal Products for Human Use (CHMP) responsible for assessing EU-wide marketing authorisation applications and evaluating changes to existing medicine authorisations.
The Pharmacovigilance Risk Assessment Committee (PRAC) monitors the safety of human medicines and oversees all aspects of risk management, including the detection, assessment, minimisation and communication of risks.
The Committee for Veterinary Medicinal Products (CVMP) is responsible for assessing EU-wide marketing authorisation applications, evaluating changes to existing medicine authorisations, and monitoring the safety of veterinary medicines.
For more information, see the full list of EMA committees or learn more about the role of national experts at the EMA.
European Commission
The European network also includes the European Commission, which is responsible for legally authorising medicines based on recommendations from the EMA. When granted by the Commission, a centralised marketing authorisation is valid in all member states, including Ireland.
Learn more about authorisation on the website of the European Commission.
Heads of Medicines Agency
The Heads of Medicines Agency (HMA) is a network of national medicines authorities in Europe, including the HPRA. Its mission is to foster an effective and efficient European medicines regulatory system.
The HMA provides strategic oversight for two authorisation routes for medicines in Europe, the mutual recognition procedure and the decentralised procedure. It also facilitates cooperation among national medicines authorities in other areas. These include other regulatory activities (such as clinical trials authorisation), as well as other areas such as training, IT infrastructure and communications.
The Coordination Groups for Mutual Recognition and Decentralised Procedures for human medicines (CMDh) and for veterinary medicines (CMDv) are responsible for the day-to-day running of the mutual recognition and decentralised procedures. Each committee is comprised of one representative per Member State. The HPRA sends representatives to these groups on behalf of Ireland.
To learn more, visit the HMA website.
Global regulatory cooperation
The European medicines regulatory network embraces and actively supports cooperation with regulatory authorities in third countries. This collaboration aims to strengthen global regulatory systems, promote mutual reliance, and enhance public health worldwide. For direct contact with other national medicines authorities within the European network, please refer to the HMA’s contact list.
International Coalition of Medicines Regulatory Authorities
The International Coalition of Medicines Regulatory Authorities (ICMRA) is an informal group of leaders from more than 35 medicines regulatory authorities worldwide. It provides strategic leadership and supports greater cooperation on shared regulatory issues and challenges, helping to strengthen the quality, safety and efficacy of medicines globally.
ICMRA promotes broader information exchange and efficient use of regulatory resources. It also works jointly on common challenges, including emerging public health issues.
To learn more, visit the ICMRA website.
World Health Organization
The World Health Organization (WHO) is the United Nations agency that connects nations, partners and people to promote health. The members of the European medicines regulatory network, including the HPRA, are designated as WHO Listed Authorities (WLA). Listed authorities are recognised as meeting international regulatory standards, guidelines and practices.
The WLA initiative ensures optimal use of limited global regulatory resources by facilitating reliance on the work and decisions of trusted regulatory authorities. The WLAs can be used as a reference point by regulatory authorities that lack the resources to perform all necessary regulatory functions, or which have not yet reached higher maturity levels for medical product oversight.
International Conference of Drug Regulatory Authorities
The International Conference of Drug Regulatory Authorities (ICDRA) provides a forum for WHO Member State regulators to collaborate and set priorities for strengthening medicines regulation. Since 1980, it has supported information‑sharing and international consensus on improving the safety, efficacy and quality of medicines.
A planning committee of regulatory representatives develops a four‑day conference programme, where participants discuss topics such as product quality, medicines safety, regulatory reform, clinical trials, harmonisation, new technologies and access. The conference concludes with recommendations for action by national agencies, WHO and partners.
To learn more, visit the WHO webpage on ICDRA.