Glossary
EU & Regulatory Science Terms | STARS Partner Organisations
EU & Regulatory Science Terms
| ATMP – Advanced Therapy Medicinal Product | |
| CRO – Contract Research Organisation | |
| CSA – Coordination and Support Action | |
| DPO – Data Protection Officer | |
| DOA – Description of Action | |
| EC – European Commission | |
| ECRIN – European Clinical Research Infrastructure Network | |
| EDPB – European Data Protection Board | |
| EDPS – European Data Protection Supervisor | |
| EEA – European Economic Area | |
| EFPIA – European Federation of Pharmaceutical Industries and Associations | |
| EMA – European Medicines Agency | |
| EU – European Union | |
| EU NCP – EU National Coordination Points | |
| EU-IN – EU Innovation Network | |
| EUnetHTA – EU Network for Health Technology Assessment | |
| EU-NTC – EU Network Training Centre | |
| GDPR – General Data Protection Regulation | |
| HMA – Heads of Medicines Agencies | |
| ITF – Innovation Task Force | |
| LO – Learning Outcomes | |
| NCA – National Competent Authorities | |
| NSC – Network Steering Committee | |
| PMO – Project Management Office | |
| SME – Small and Medium-sized Enterprises | |
| STARS – Strengthening Training of Academia in Regulatory Sciences and Supporting Regulatory Scientific Advice |
STARS Partner Organisations:
| aCBG – Agentschap College Ter Beoordeling Van Geneesmiddelen (NL) | Agency of the Dutch Medicines Evaluation Board (also see: MEB) | The Dutch Medicines Evaluation Board assesses and monitors the efficacy, risks and quality of medicines for humans and animals. The Board is an independent administrative body supported by a specialised agency. | |||
| AEMPS – Agencia Española de Medicamentos y Productos Sanitarios (ES) | Spanish Agency for Medicines and Health Products | AEMPS is a state agency attached to the Spanish Ministry of Health, Consumption and Social Welfare. It is responsible for guaranteeing the quality, safety, efficacy and correct information of medicines and health products. | |||
| AGES – Österreichische Agentur für Gesundheit und Ernährungssicherheit (AT) | Austrian Agency for Health and Food Safety | The Austrian Agency for Health and Food Safety is a limited company of the Republic of Austria, owned by the Austrian Federal Ministry of Labour, Social Affairs, Health and Consumer Protection and the Austrian Federal Ministry for Sustainability and Tourism. | |||
| AIFA – Agenzia Italiana del Farmaco (IT) | Italian Medicines Agency | The Italian Medicines Agency is the national authority responsible for drugs regulation. It is a public body operating autonomously under the direction of the Ministry of Health and the Ministry of Economy. | |||
| ANMS – Agence nationale de sécurité du médicament et des produits de santé (FR) | French Agency for the Safety of Medicines and Health Products | ANMS is responsible for assessing the benefits and risks associated with the use of health products throughout their life-cycle. It assesses the safety, efficacy and quality of these products and balances patient safety with access to novel therapies. | |||
| BfArM – Bundesinstitut für Arzneimittel und Medizinprodukte (DE) | German Federal Institute for Drugs and Medical Devices | The Federal Institute for Drugs and Medical Devices is an independent federal higher authority within the portfolio of the German Federal Ministry of Health. Its is tasked with improving the safety of medicinal products, as well as evaluating the risks of medical devices. | |||
| DLR-PT – DLR Projektträger (DE) | Project Management Agency of the German Aerospace Center | DLR is a non-governmental, non-profit German research organisation. Its Project Management Agency is mandated with the implementation and management of research funding measures by the German Federal Ministries and the EC. | |||
| EMA – European Medicines Agency (EU) | European Medicines Agency | The European Medicines Agency is a decentralised agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. | |||
| FAMHP – Federal Agency for Medicines and Health Products (BE) | Belgian Federal Agency For Medicines And Health Products | FAMHP is the Belgian authority responsible for the quality, safety and efficacy of medicines and health products. It works at both national and international level to ensure the population the optimal use of the medicines and health products they need. | |||
| Fimea – Finnish Medicines Agency (FI) | Finnish Medicines Agency | Fimea is the national competent authority for regulating pharmaceuticals in Finland. As a central administrative agency operating under the Ministry of Social Affairs and Health it promotes the health and safety of the population. | |||
| HPRA – Health Products Regulatory Authority (IE) | Irish Health Products Regulatory Authority | The Health Products Regulatory Authority is a regulatory state agency in Ireland. Its role is to protect and enhance public and animal health by regulating medicines, medical devices and other health products. | |||
| INFARMED – Autoridade Nacional Do Medicamento E Produtos Da Saude (PT) | National Authority of Medicines and Health Products | Infarmed is a Portugese government agency accountable to the Health Ministry, that evaluates, authorises, regulates and controls human medicines as well as health products, medical devices and cosmetics. | |||
| MEB – Medicines Evaluation Board (NL) | Agency of the Dutch Medicines Evaluation Board (also see: aCBG) | The Dutch Medicines Evaluation Board assesses and monitors the efficacy, risks and quality of medicines for humans and animals. The Board is an independent administrative body supported by a specialised agency. | |||
| MHRA – Medicines And Healthcare Products Regulatory Agency (UK) | British Medicines And Healthcare Products Regulatory Agency | The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. It is an executive agency, sponsored by the Department of Health and Social Care. | |||
| MA – Medicines Authority (MT) | Maltese Medicines Authority | The Medicines Authority protects and enhances public health in Malta through the regulation of medicinal products and pharmaceutical activities. | |||
| MPA – Medical Products Agency (SE) | Swedish Medical Products Agency | The Medical Products Agency is Sweden's national authority responsible for regulation and surveillance of the development, manufacturing and marketing of drugs and other medicinal products. | |||
| OGYÉI – Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (HU) | Hungarian National Institute of Pharmacy and Nutrition | OGYÉI Tis a licensing authority for pharmaceutical and public administrational matters. It provides the Hungarian public with safe, effective and quality medicines in accordance with the regulations. | |||
| PEI – Paul-Ehrlich-Institut (DE) | German Federal Institute for Vaccines and Biomedicines | PEI is the Federal Institute for Vaccines and Biomedicines. It is a senior federal authority in the field of medicinal products providing services in public health. It also evaluates the benefit-risk balance of biomedicines, vaccines and immunological medicines. | |||
| SAMLV – State Agency of Medicines of Latvia (LV) | Latvian State Agency of Medicines | The State Agency of Medicines of Latvia is a State institution under the supervision of the Ministry of Health of the Republic of Latvia. It implements pharmaceutical legislation and in addition provides objective and analytical information. | |||
| SÚKL – Státní ústav pro kontrolu léčiv (CZ) | Czech State Institute for Drug Control | SKÚL is a government institution of the Czech Republic. It is responsible for the regulation of the production of pharmaceuticals and the clinical evaluation of medicines. It also monitors the marketing of both medicines and medical devices. | |||
| URPL – Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (PL) | Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products | URPL is a central government administrative authority competent for matters concerning the marketing authorisation of medicinal and biocidal products, medical devices and clinical trials. | |||
| VVKT – Valstybinė vaistų kontrolės tarnyba (LT) | Lithuanian State Medicines Control Agency | The State Medicines Control Agency 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. | |||
