The European regulatory system for medicines is a unique model in the global regulatory environment. The system is based on a network of all national medicines regulatory authorities for both human and veterinary medicines from Member States in the European Union and European Economic Area, united in the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA), working closely together in an integrated fashion, supported by other European organisations such as the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe. By working closely together, the network can draw on the resources and expertise of the whole EU. National Competent Authorities (NCAs) rely on each other’s work to avoid duplication and share workloads and scientific competence. For example, Member States do not conduct inspections in each other’s territories, avoid duplication of assessments and work together on official batch control for biologicals and post-marketing surveillance and safety issues.
The work of the network is coordinated by EMA and the HMA. Amongst other tasks, EMA’s responsibilities include the coordination of the scientific evaluation of those medicines that are authorised through the centralised procedure (most new active substances are now authorised through the centralised procedure) and referrals, support for innovative products (including the provision of scientific advice and qualification of biomarkers), designation of orphan status or agreement to paediatric investigation plans (PIPSs), as well as the coordination of the EU wide work on safety monitoring of medicines. NCAs work closely with EMA providing the scientific expertise to EMA committees for assessing centralised products, supporting innovation including centralised scientific advice, work on orphan and paediatric medicines and EU wide safety procedures through scientific resource to the various scientific committees (CAT, CHMP, COMP, CVMP, HMPC, PDCO, PRAC), working parties and experts groups of EMA.
NCAs handle applications for all medicines that are authorised nationally or through the decentralised and mutual recognition procedure, conduct post-marketing surveillance and enforcement in their territories, authorise clinical trials, provide national scientific advice, support innovation and conduct inspections. Scientific work for non-centralised products is coordinated through the coordination groups for mutual recognition and decentralised procedures, human and veterinary (CMDh and CMDv).
All NCAs are represented in the HMA. The HMA addresses key strategic issues for the network, ensures consistency across the EU, shares best practices and makes the best use of resources across the network. The HMA, including the CMDh and CMDv, works closely with EMA and the European Commission to ensure the efficient and effective operation of the European medicines regulatory network.
In the EU, medicines are governed by a large body of EU legislation, which aims to guarantee high standards of quality, safety and efficacy of medicinal products, as well as appropriate information, and to promote the functioning of the internal market. The EU legislation today covers the whole lifespan of a medicinal product from the research phase (clinical trials of human medicines), the approval stage, manufacturing, distribution to post-marketing obligations, including sectorial legislation on orphan and paediatric medicines, advanced therapy medicinal products, as well as maximum residue limits for food safety. There are some exemptions, notably pricing and reimbursement for human medicines, which remain a national competence. Progress has been made for closer interaction with health technology assessment (HTA) bodies but there are further opportunities that could be exploited. It is also important that there are strong links to public health authorities to ensure collaboration on areas such as vaccines and emergency management. The European legislation governing human medicines has been strengthened significantly in recent years in the areas of pharmacovigilance, falsified medicines and clinical trials. Drafting of new legislation on veterinary medicines is ongoing. Full and harmonised implementation of recent legislation will be a priority for the network in the coming years.
The degree of integration of the network has increased over recent years, for example since 2012 the network has strengthened its assessment of EU wide safety issues with the creation of the Pharmacovigilance Risk Assessment Committee (PRAC). Inspection activity is increasingly coordinated as well as the development of IT systems that underpin the regulatory work of the network. The network has also been jointly assessing clinical trials under the Voluntary Harmonisation Procedure in anticipation of the application of the new Clinical Trials Regulation and veterinary periodic safety reports (PSURs) in a work-share project. The regulatory environment had also seen over the past years, in parallel with increasing demands for more transparency, greater involvement from patients in the work of the regulatory authorities.