The European Medicines Agency (EMA) in Amsterdam is the scientific coordinative body for marketing authorisation and safety of medicinal products in Europe. In the various committees and working groups, representatives of all national medicines agencies discuss issues and prepare decisions for the European Commission. Decisions and recommendations of the EMA are thus drawn up jointly within the EU-network.
The EMA is the EU body that coordinates the existing scientific resources provided by the EU Member States for the evaluation, supervision and pharmacovigilance of medicinal products.
The EMA offers member states and EU institutions the best possible scientific advice on all questions relating to the evaluation of the quality, safety and efficacy of medicinal products for humans and animals. The legal basis for this is provided by EU pharmaceutical legislation.
Together with the member states and the European Commission as partners in a European network, the EMA fulfils the following tasks:
- Provide independent, science-based recommendations on the quality, safety and efficacy of medicinal products, as well as on general topics relevant to human and animal health
- Creation by the European Commission of efficient and transparent procedures for the evaluation of the marketing authorisation of medicinal products in an EU-wide uniform process.
- Implementation of measures for comprehensive monitoring of the quality, safety and efficacy of authorised medicinal products to ensure that the benefits outweigh the risks of a medicinal product.
- Scientific advice and promotion of the development and availability of new and innovative medicines
- establishment of safe limits for residues of medicinal products in animals intended for human consumption
- Involvement of patient representatives, health professionals and other stakeholders
- publication of objective and comprehensible information on medicinal products and their use
- Development of best practice models for the monitoring and evaluation of medicinal products in Europe and contribution to the harmonisation of regulatory standards in the member states and the European Commission at an international level.
The CHMP prepares the decisions of the EMA concerning all questions concerning medicinal products for human use in accordance with Regulation (EC) No 726/2004.
The CHMP plays a central role in the authorisation of medicinal products in the European Union and in their post-authorisation monitoring (pharmacovigilance).
The CHMP provides scientific opinions to evaluate the risk-benefit balance of medicinal products and to guarantee the quality, safety and efficacy of medicinal products for consumers/patients. The legal basis is provided by EU legislation, in particular Directive 2001/83/EC.
The continuous monitoring of medicinal products on the market (pharmacovigilance) is ensured by the network of national agencies. In Austria, this task is performed by BASG / AGES Medizinmarktaufsicht. The CHMP monitors at European level the reports on adverse reaction reports and makes recommendations to the European Commission in case amendments or withdrawal of a marketing authorisation should be necessary. The following decision of the European Commission will be implemented in the Member States.
further information can be found on the CHMP page of the EMA
The CHMP has various working groups and committees at its disposal to fulfil its tasks, including the PRAC.
The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for evaluating all safety aspects related to human medicinal products. This includes the recognition and evaluation of safety signals and their assessment with regard to the benefit-risk ratio of medicinal specialities as well as the selection, introduction and communication of risk-minimising measures and the planning and evaluation of safety studies and pharmacovigilance inspections.
The recommendations of this committee form the basis for the decisions of the CHMP and the CMD(h) in all safety-relevant matters. Decisions are taken either by consensus or by majority decision.
Further information can be found on the PRAC page.
The CVMP is the committee at the European Medicines Agency that is responsible for preparing opinions on questions concerning medicines for veterinary use.
The members and alternates of the CVMP are nominated by the European Union Member States, in consultation with the Agency's Management Board. They are chosen on the strength of their qualifications and expertise with regard to the evaluation of medicines. They serve on the Committee for a renewable period of three years.
For further information, visit page CVMP
The Paediatric Committee (PDCO), was established under Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use. The PDCO is responsible, among other things, for the scientific evaluation of paediatric investigation plans (PIPs) for use in children and adolescents. Another task is the comprehensive implementation of paediatric regulation with the aim of improving the health of the paediatric population in Europe.
Further information can be found on the PDCO page.
COMP is responsible for reviewing applications for medicines developed for the prevention or treatment of rare diseases. This applies to diseases affecting no more than five out of 10,000 people in the EU.
Further information can be found on the COMP page.
The HMPC was established in September 2004 and replaced the CPMP Working Group. It prepares the decisions of the EMA on all matters concerning the registration of Traditional Herbal Medicinal Products in accordance with Regulation (EC) No 726/2004 and Directive 2004/24/EC.
Further information can be found on the HMPC page.
The CAT prepares the decisions of the EMA concerning all questions on advanced therapies in accordance with Regulation (EC) No 1394/2007.
Further information can be found on the CAT page.
The focus of the HMA, in which all heads of the medicines agencies of the European Economic Area (EEA) are represented, is on the continuous professional exchange among the agencies. Several working groups (HMA Working Groups) have been established for this purpose.
Further information can be found on the HMA website
These coordination groups deal with all questions relating to marketing authorisations for medicinal products in two or more EU member states.
If there is no agreement on scientific issues between the member states in these procedures, the open points in the CMD will be discussed in a CMD-referral procedure.
The Group also develops implementation rules and guidelines relating to new legislation and opinions on draft legislation.
BASG/AGES coordinates EU4H 11 Joint Action to strengthen EEA Medicines Inspectorates
The Joint Action EU4H 11 included in the EU4Health Programme funded by the European Commission aims at strengthening capacities of EEA GMP/GDP inspectorates. The total budget of this Joint Action amounts to more than 3 Million Euros, 80% of the costs will be co-financed by the European Commission.
The Joint Action is steered by BASG/AGES as Coordinator, together with the National Competent Authorities of France (ANSM), Croatia (HALMED) and Hungary (OGYÉI/NIPN) as work package leaders. In total, 31 EU/EEA Medicines Agencies are participating whereas further EU/EEA GMP Inspectorates are to be included within the duration of the Action.
The three main goals of EU4H 11 are:
- Strengthening the Joint Audit Programme (JAP) for EEA GMP Inspectorates: Heads of Medicines Agencies have agreed to the setting up of this JAP to verify the implementation and equivalence of EEA GMP inspectorates with relevant provisions of European Directives into national laws and consequently maintain mutual confidence in the GMP inspection systems. Additionally, the JAP serves as a basis for Mutual Recognition Agreements (MRA) with Third-Countries. This Joint Action EU4H 11 will work on optimising training and qualification processes for auditors as well as the JAP procedure. Furthermore, the co-financing of costs related to JAP activities supports member states’ participation in the Joint Audit Programme.
- Reviewing the national implementation of the European GDP legislation / guidelines and developing a proposal to include GDP to the existing Joint Audit Programme. By promoting collaboration between EEA GDP Inspectorates, the Joint Action will strengthen the EEA GDP Inspectorates network and work towards a harmonization of GDP inspections standards.
- Strengthening /EEA inspectors’ capacities by establishing harmonised training and qualification processes for GMP inspectors, in cooperation with the PIC/S Inspectorates’ Academy. Furthermore, the co-financing of costs related to training activities supports member states’ participation.
The Health and Digital Executive Agency (HaDEA) is implementing this Joint Action EU4H 11.
The Kick-off meeting for EU4H 11 was successfully organised as a hybrid meeting at BASG/AGES, Vienna from 5-6 December 2022.
List of participants:
National Competent Authority
ÖSTERREICHISCHE AGENTUR FUR GESUNDHEIT UND ERNÄHRUNGSSICHERHEIT GMBH (AGES)
FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS (FAMHP)
AGENCIJA ZA LIJEKOVE I MEDICINSKE PROIZVODE (HALMED)
PHARMACEUTICAL SERVICES, MINISTRY OF HEALTH (PHS MOH)
STATNI USTAV PRO KONTROLU LECIV (SÚKL)
LAAKEALAN TURVALLISUUS-JA KEHITTAMISKESKUS (FIMEA)
AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)
AGENCE NATIONALE DE LA SECURITE SANITAIRE DE L ALIMENTATION DE L ENVIRONNEMENT ET DU TRAVAIL (ANSES)
ZENTRALSTELLE DER LÄNDER FÜR GESUNDHEITSSCHUTZ BEI ARZNEIMITTELN UND MEDIZINPRODUKTEN (ZLG)
ETHNIKOS ORGANISMOS FARMAKON (EOF)
ORSZAGOS GYOGYSZERESZETI ES ELELMEZES-EGESZSEGUGYI INTEZET (OGYÉI/NIPN)
ICELANDIC MEDICINES AGENCY (LYFJASTOFNUN)
HEALTH PRODUCTS REGULATORY AUTHORITY (HPRA)
AGENZIA ITALIANA DEL FARMACO (AIFA)
MINISTERO DELLA SALUTE (MoH-DGSAF-IT)
ZALU VALSTS AGENTURA (ZVA)
VALSTYBINE VAISTU KONTROLES TARNYBAPRIE LIETUVOS RESPUBLIKOS SVEIKATOS APSAUGOS MINISTERIJOS (VVKT)
MINISTERE DE LA SANTE (MOHLUX)
THE MEDICINES AUTHORITY (MALTA MA)
MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT (IGJ-NL)
THE NORWEGIAN MEDICINES AGENCY (NOMA)
GLOWNY INSPEKTORAT FARMACEUTYCZNY (CPI)
INFARMED - AUTORIDADE NACIONAL DO MEDICAMENTO E PRODUTOS DA SAUDE IP (INFARMED)
DIRECCAO-GERAL DE ALIMENTACAO E VETERINARIA (DGAV)
AGENTIA NATIONALA A MEDICAMENTULUI SI A DISPOZITIVELOR MEDICALE DIN ROMANIA - NATIONAL AGENCY FOR MEDICINES AND MEDICAL DEVICES OF ROMANIA (ANMDMR)
STATNY USTAV PRE KONTROLU LIECIV (SÚKL SK)
JAVNA AGENCIJA REPUBLIKE SLOVENIJE ZA ZDRAVILA IN MEDICINSKE PRIPOMOCKE (JAZMP)
AGENCIA ESPANOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS (AEMPS)
Further information: Mag. Andreas Kraßnigg, Project Lead / Main Coordinator Contact: email@example.com
Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them.