Heads of Medicines Agencies
The Heads of Medicines Agencies (HMA) is a network of the heads of the 'national competent authorities', the agencies responsible for the regulation of human and veterinary medicines in the individual countries of the European Economic Area (EEA).
The HMA works to foster an effective and efficient European medicines regulatory system. It is supported by working groups covering specific areas of responsibility and by the Heads of Medicines Agencies Management Group and Permanent Secretariat.
The European Medicines Agency is a member of the HMA. It works with the other members on these key activities:
- addressing key strategic issues for the European medicines regulatory network, such as the exchange of information and sharing of best practice;
- collectively, being responsible for all areas of medicines regulation, including the mutual recognition and decentralised procedures;
- focusing on the development, coordination and consistency of the European medicines regulatory network;
- supporting the network by providing high-quality professional and scientific resources;
- providing a focus for making the most effective use of scarce resources across the network, such as developing and overseeing arrangements for work-sharing.
Task Force on the Availability of Authorised Medicines for Human and Veterinary Use
EMA and the HMA created a task force in December 2016 to provide strategic support and advice to tackle disruptions in supply of human and veterinary medicines and ensure their continued availability.
Supply disruptions and medicine shortages are a growing problem in Europe, affecting all stakeholder groups. Their causes include economic factors, problems in manufacturing and quality issues, such as non-compliance with good manufacturing practice.
Key priorities of the task force include:
- looking at ways to minimise supply disruptions and avoid shortages by facilitating approval and marketing of medicines using the existing regulatory framework (for example by work sharing and reduced timetables when possible);
- developing strategies to improve prevention and management of shortages caused by disruptions in the supply chain (for example developing guidance for companies on reporting of shortages);
- encouraging best practices within the pharmaceutical industry to prevent shortages;
- improving sharing of information and best practices among EU regulatory authorities to better coordinate actions across the EU;
- fostering collaboration with stakeholders and enhancing communication of supply problems to EU citizens.
The scope of this work covers human and veterinary medicines authorised via the centralised procedure, decentralised procedure, mutual recognition or purely national procedures, in the following situations:
- authorised medicines that are not marketed or are no longer marketed;
- supply chain disruptions directly preventing the availability of products that are authorised and marketed.
The task force is co-chaired by Kristin Raudsepp, Director General, Estonian State Agency of Medicines and Noel Wathion, EMA Deputy Executive Director. Its steering committee and three thematic working groups on marketing authorisation, supply disruptions and communication contain representatives of the HMA, EMA, the European Commission and the chairs of the CMDh and CMDv.
For more information, see:
EU Network Training Centre (EU NTC)
EMA and HMA have jointly set up the EU Network Training Centre (EU NTC), with the aim of ensuring the exchange of good scientific and regulatory practices across the European medicines regulatory network.
The EU NTC will achieve this by harmonising training standards and offering high quality and relevant training opportunities.
For more information see HMA EU NTC.
Regulatory Optimisation Group (ROG)
The Regulatory Optimisation Group (ROG) is an HMA subgroup co-chaired by EMA focused on optimising regulatory and business operations and reducing regulatory burden. It covers both human and veterinary domains and consists of regulatory, business and IT experts from the regulatory network as core members, and representatives of the innovative, generic and non-prescription industry as non-voting participants.
The ROG will focus on regulatory optimisation of type IA variations in 2017.
For more information see HMA Regulatory Optimisation Group.
Task Force on Big Data
The joint HMA/EMA Task Force on Big Data will explore how EEA medicines regulators can use big data to support research, innovation and robust medicines development. 'Big data' refers to extremely large sets of information which require specialised computational tools to enable their analysis and exploitation. These data might come from electronic patient health records, genomics, social media, clinical trials, spontaneous adverse reaction reports, etc.
The group will map sources and characteristics of big data, explore the potential applicability and impact of big data on medicines regulation, explore the need for changes to regulatory guidelines or legislation, create a roadmap for the development of big data capabilities in the national competent authorities, and collaborate with other regulatory authorities and partners outside the EEA.
For more information see HMA/EMA Task Force on Big Data.