National institutions

Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps)The Afssaps is the competent French authority for all safety decisions taken concerning health products from their manufacturing to their marketing. The Afssaps carries out three core missions: scientific and medico-economic evaluation; laboratory control and advertising control; inspection of industrial sites. The Agency also coordinates vigilance activities relating to all products for which it is relevant. It also takes policing decisions in the name of the State with respect to two principles: contradiction and transparency. Decisions are discussed and motivated through the evaluation by a network of internal and external experts.
AGES-PharmMed LCM The Austrian Agency’s objective is ensuring health protection by an effective and efficient evaluation of food safety and by the epidemiological surveillance of communicable and non-communicable infectious diseases. The Agency is also in charge of all Austrian agenda of drug registration and control.
Bulgarian Drug Agency The Bulgarian Drug Agency has been established as the regulatory authority for supervision of quality, efficacy and safety of medicinal products. BDA has acquired the authority to issue marketing authorizations of medicinal products.
Danish Medicines Agency (DMA)The Danish Medicines Agency assumes the role as competent authority with respect to the technical aspects of clinical investigations of medical devices from the Scientific Ethical Committee System. There is a requirement for authorisation, from the DMA, for the clinical investigation of medical devices on human subjects.
Finnish Investigators Network for Paediatric Medicines (FINPEDMED)FINPEDMED was established in joint collaboration with Finland's five university hospitals and their paediatric clinics. The network operates on a non-profit basis and aims to improve both academic and sponsored paediatric clinical trials for the benefit of children's health. The network facilitates the recruitment of experts and investigators to work as specialists in trials supported by industry or other funding.
German Federal Institute for Drugs and Medical Devices (BfArM)The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent higher federal authority within the portfolio of the Federal Ministry of Health. One of the main tasks of the BfArM is the authorisation of finished medicinal products on the basis of the German Medicines Act.
German Medicines Evaluation Board (MEB)The MEB is responsible for the authorisation of safe and effective medicinal products and for their subsequent monitoring on the Dutch market. The MEB does this by providing scientific advice, assessing marketing authorisation dossiers and promoting the safe and effective use of medicinal products.
Greek National Organization for Medicines The National Organization for Medicines (EOF) is a public entity of the Ministry of Health. EOF mission is to ensure public health and safety.
Icelandic Medicines Control Agency (IMCA)The IMCA is an independent regulatory authority, which appertains to the Ministry for Health and Social Security. The Agency issues permissions for clinical trials, classifies natural products and food supplements into medicines and regular commodities, controls ads on medicines and publishes the catalogue of Medicinal Product.
INFARMED-The National Pharmacy and Medicines InstituteThe Portuguese National Authority of Medicines and Health Products is a Government agency accountable to the Health Ministry. Amongst INFARMED's top activities the regulation and supervision of medicinal and health products from research up to their use by healthcare professionals and patients is of particular importance. INFARMED performs at national and European levels its competences and responsibilities of National Competent Authority on medicines and health products.
Institut National de la Santé et de la Recherche Médicale (INSERM) Inserm is the only French public research body entirely dedicated to human health. Its researchers are committed to studying all diseases, whether common or rare, through their research in the fields of biology, medicine and public health. In order to fulfill this mission, the Institute has worked in close partnership with other public or private research institutions and care centers.
Medical Products Agency of SwedenThe Medical Products Agency (MPA) is the Swedish national authority responsible for regulation and surveillance of the development, manufacturing and sale of drugs and other medicinal products. The Swedish Medical Products Agency is one of the leading regulatory authorities in the EU.
Medicines and Healthcare products Regulatory Agency (MHRA) Part of the United Kingdom Department of Health, the MHRA is the government executive agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
National Agency for Medicines of FinlandThe National Agency for Medicines responsibilities are to maintain and promote the safety and safe use of medicinal products, medical devices and blood products. Its areas of focus are paediatric and biological medicinal products.
Norwegian Medicines Agency The Norwegian Medicines Agency (NoMA) is the national, regulatory authority for new and existing medicines and the supply chain. The agency is responsible for supervising the production, trials and marketing of medicines. It approves medicines and monitors their use, and ensures cost-efficient, effective and well-documented use of medicines. The inspectorate also supervises the supply-chain. NOMA also regulate prices and trade conditions for pharmacies.
RIPPS - Réseau d’Investigations Pédiatriques des Produits de Santé The RIPPS was created under the auspices of Inserm and the French Paediatric Society (SFP) in order to facilitate the performance of clinical trials in France and to guarantee their quality in children
Romanian National Medicines Agency The National Medicines Agency (NMA) carries on the tradition in ensuring medicinal products quality. It is the Mission of the National Medicines Agency (NMA) to contribute to the protection and promotion of public health through: evaluating at the highest scientific competence level of the authorization documentation for the purpose of bringing on the market high quality, safe and effective medicinal products; supervising the safety of the medicinal products in the therapeutical circuit through the activities of inspection and pharmacovigilance; ensuring for the patients and the healthcare personnel the access to useful and correct information regarding the medicinal products authorized to be brought on the market in Romania; ensuring the administrative effectiveness and efficiency of the organization (NMA) and the transparency of the practices and procedures used.
Slovenian Agency for Medicinal Products and Medical Devices The new Agency for Medicinal Products and Medical Devices (JAZMP) has replaced the former Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (ARSZMP). The Agency is a constitutive body of the Ministry of Health and performs regulatory, professional and inspection activities related to the testing, production and trade of medicines and medical devices. The Agency co-operates with other state and EU bodies involved in regulatory affairs, principally the European Medicines Agency EMEA, the European Pharmacopoeia, and the national official medicines control laboratory.
State Agency of Medicines of EstoniaThe SAM is the National Drug Regulatory Authority for Human and Veterinary Products and Competent Authority for Medical Devices in Estonia. SAM has the following obligations: marketing authorization and quality control of medicinal products including biological products, evaluation and approval of applications for clinical trials, import and export authorization of medicinal products, control of licit use of psychotropic and narcotic substances, control over precursors, drug information, advertising and promotion control and pharmaceutical inspection.
State Agency of medicines of LatviaThe State Agency of Medicines is a Regulatory Authority under a direct jurisdiction of the Ministry of Health. The objective of the Agency is ensuring availability of efficient, safe and qualitative medicines to the Latvian population.
State Institute of Drug Control of the Slovak RepublicThe State Institute for Drug Control (SIDC) in Bratislava is the institution of the Ministry of Health of the Slovak Republic responsible for ensuring surveillance of the quality, efficacy and safety of medicinal products for human use and medicinal products used in health care.
State Medicines Control Agency of LithuaniaThe State Medicines Control Agency (SMCA) is a governmental body of the Republic of Lithuania. Its main responsibility is the protection of public health, through the evaluation and supervision of medicines for human use including the scientific evaluation of marketing authorisation applications, the supervision of manufacturing authorisation holders, the supervision of clinical trials.
The Irish Medicines BoardAmong its many activities, the IMB regulates clinical trials, as well as monitoring and inspecting products on the market to ensure their safety and efficacy.
The Japanese National Institute of Health Sciences The major responsibilities of the NIHS involve extensive testing and research to ensure the quality, efficacy, and safety of chemical substances (including pharmaceuticals and food) that are closely related to people's lives.

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