Groups and Committees
Homeopathic Medicinal Products Working Group (HMPWG)
The aim of the group is to create a forum for exchange of regulatory and scientific expertise regarding the assessment of the quality, safety and homeopathic use of homeopathic medicinal products for human and veterinary use; It provides guidance on the assessment of homeopathic medicinal products on request from Competent Authorities, and guidance for applicants on the registration of homeopathic medicinal products.
The European Medicines Agencies Cooperation on Legal and Legislative Issues (EMACOLEX)
In support of the efforts of the European Medicines Regulatory Network with regard to the public and animal health, the European Medicines Agencies Co-operation on Legal and Legislative Issues (EMACOLEX) will by dialogue and co-operation enhance knowledge, trust and confidence between legal staff and others involved in legal matters to ensure the best legal assistance to the Network and the individual national competent authorities.
Committee for Orphan Medicinal Products (COMP)
The COMP is responsible for evaluating applications for orphan designation. This designation is for medicines to be developed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. In the European Union (EU), a disease is defined as rare if it affects fewer than 5 in 10,000 people across the EU. The European Commission decides whether to grant an orphan designation for the medicine based on the COMP's opinion.
Heads of Medicines Agencies (HMA)
The Heads of Medicines Agencies (HMA) is a network of the heads of the National Competent Authorities (NCA) whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area. The HMA co-operates with the European Medicines Agency (EMA) and the European Commission in the operation of the European medicines regulatory network and it is a unique model for cooperation and worksharing on statutory as well as voluntary regulatory activities.
Clinical Trials Facilitation Group (CTFG)
This Group was established in to coordinate the implementation of the EU clinical trials directive 2001/20 EC across the member states. In relation to clinical trials, the Clinical Trials Facilitation and Coordination Group (CTFG) acts as a forum for discussion to agree on common principles and processes to be applied throughout the European medicines regulatory network (EMRN). It also promotes harmonization of clinical trial assessment decisions and administrative processes across the national competent authorities.
WGQM - Working Group of Quality Managers (WGQM)
In support of the efforts of the European Medicines Regulatory Network (EMRN) with regard to public and animal health, the HMA Working Group of Quality Managers (WGQM) shall provide guidance relating to quality management and best practice benchmarking. The HMA WGQM consists of quality professionals from the EEA National Competent Authorities (NCAs), the European Medicines Agency (EMA)and the European Directorate for the Quality of Medicines & Health Care (EDQM).
The Network of Competent Authorities on Pricing and Reimbursement (NCAPR)
The Network of Competent Authorities on Pricing and Reimbursement (NCAPR) is an informal co-operation platform created in 2008, in order to discuss issues and challenges in the field of pricing and reimbursement of medicines. The NCAPR is aimed at bringing together policymakers and decision-makers to share their expertise, concerns and to explore common positions concerning current and future issues related to accessibility and the pricing and reimbursement of medicines.
The Committee on Herbal Medicinal Products (HMPC)
The Committee on Herbal Medicinal Products is the European Medicines Agency's (EMA) committee responsible for compiling and assessing scientific data on herbal substances, preparations and combinations, to support the harmonization of the European market. The Committee was established in accordance with Regulation (EC) No 726/2004 and the Herbal Directive, which introduced a simplified registration procedure for traditional herbal medicinal products in EU Member States.
Pharmacovigilance Risk Assessment Committee (PRAC)
PRAC is the European Medicines Agency's (EMA) committee responsible for assessing and monitoring the safety of human medicines. The PRAC was formally established in line with the pharmacovigilance legislation which came into effect in 2012 to help strengthen the safety monitoring of medicines across Europe. The PRAC is responsible for assessing all aspects of risk management of human medicines.
The Working Group of Communications Professionals (WGCP)
The Working Group of Communications Professionals (WGCP) was established in 2007 by the HMA to help develop communications expertise, share good practice, help co-ordinate communications across the HMA network in a crisis, develop HMA’s engagement with its stakeholders and help develop and improve the website for the HMA.
Directors of Pharmaceutical Policy (DPP)
The meeting of the Directors of Pharmaceutical Policy of the European ministries of health, organized during each presidency, is encouraging strategic reflection and discussion on current and future developments in the pharmaceutical system in the EU and its Member States. These discussions are purely informal and, where relevant, can be used as a contribution to further reflection in the appropriate EU bodies, in particular within the Group on Pharmaceuticals and Medical Devices, when it comes to areas within the EU's competence.
Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)
The CMDh started its activities in November 2005 in order to coordinate and facilitate the operation of the mutual recognition procedure. The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh), was set up in Directive 2004/27/EC for the examination of any question relating to marketing authorisations of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure. The task of the CMDh was substantially extended in 2012 by Directive 2010/84/EU, amending Directive 2001/83/EC as regards pharmacovigilance.
The Paediatric Committee (PDCO)
The Paediatric Committee is the European Medicines Agency's (EMA) scientific committee responsible for activities on medicines for children and to support the development of such medicines in the European Union by providing scientific expertise and defining paediatric needs. The PDCO was established in line with the Paediatric Regulation, which came into effect in 2007, to improve the health of children in Europe by facilitating the development and availability of medicines for children aged 0 to 17 years.
Conference “Access to medicines and Medical Devices”
The 3 As Conference is one of the emblematic events in the health sector during the Portuguese Presidency of the Council of the European Union. The Conference will promote the themes of the Portuguese Presidency's agenda, namely, the 3 main pillars Availability, Accessibility and Affordability. The aim is to define priorities and policy options that will consequently translate into concrete actions regarding access to medicines and medical devices across the EU.
INNO – Innovations in Healthcare
The”INNO” meeting was the first joint meeting of four groups which are involved with giving scientific advice and/or regulatory guidance to INNOvators: SAWP, CTFG, EU-IN and EUnetHTA.
La Valletta Technical Committee
The La Valletta group meeting aims to improve access to new and innovative medicines and therapies and support the sustainability of their national health systems for the mutual benefit of the citizens of the countries that form the group. It has a particular focus on cancer drugs, treatments for autoimmune diseases, orphan drugs, biosimilars and products with a substantial budgetary impact
The Committee for Medicinal Products for Human Use) + The Committee for Advanced Therapies (CHMP + CAT)
The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: conducting assessment of EU-wide marketing authorization applications; recommending to the European Commission a medicine's marketing authorization. The Committee for Advanced Therapies (CAT) is the European Medicines Agency's (EMA) committee responsible for assessing of advanced therapy medicinal products ATMP.
Working Group of Enforcement Officers (WGEO)
The Working Group of Enforcement Officers (WGEO) is composed of representatives of the medicines national and international medicines competent authorities, police and customs, WHO, Council of Europe, as well as of the European medicine agency and the European Commission. The group's objective is to share knowledge and experiences, organize and participate in joint investigations, adopt best practices and facilitate international cooperation in pharmaceutical crime investigations.
Heads of the European Medicines Agencies + Competent Authorities for Medical Devices (HMA + CAMD)
The heads of the European Medicines Agencies and the national competent authorities for medical devices, responsible for the regulation of medicines (Heads of Medicines Agencies - HMA) and medical devices in the European Space (Competent Authorities for Medical Devices - CAMD), as well as representatives of the European Agency Medicines (EMA) and European Commission. These two groups (HMA and CAMD) will jointly meet to discuss possible forms of cooperation between the two sectors in the scope of the European regulatory system.
HMA’s Risk assessment tool for market surveillance testing (HMA-RATMST)
The aim of the meeting is to discuss, and compile learnings on, the experience gained to date on use of the pre-marketing tool and its risk assessment data and assessor test recommendations. This will involve the input of the OMCLs, the EDQM and the Assessors, as well as to work on developing the post-marketing elements for the current HMA pre-marketing tool. This would be done by bringing key stakeholder groups together to work on a set of objectives, as outlined below. The key stakeholders will be representatives of the HMA, the EMA, the OMCL Network, the GMP Inspectors, the Rapid Alert Network, the Pharmaceutical Assessors and the Biological Assessors.