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LinksThis page contains links to external websites. Spectrum Regulatory Solutions has no responsibility for the content of these sites. The presence or absence of any particular website should not be construed as reflecting the opinion of Spectrum Regulatory Solutions on that resource. Austria: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH Belgium: Agence Fédérale des Médicaments et des Produits de Santé Bulgaria: Bulgarian Drug Agency (BDA) Croatia: Ministry of Health and Social Welfare of the Republic of Croatia Cyprus: Ministry of Health Czech Republic: State Institute for Drug Control (SÙKL) Denmark: Danish Medicines Agency (Lægemiddelstyrelsen DKMA) Estonia: State Agency of Medicines Finland: National Agency for Medicines France: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Greece: National Organization for Medicines Hungary: National Institute of Pharmacy Iceland: Icelandic Medicines Control Agency (IMCA) Ireland: Irish Medicines Board (IMB) Italy: Agenzia Italiana del Farmaco (AIFA) Latvia: State Agency of Medicines Liechtenstein: Kontrollstelle für Arzneimittel beim Amt für Lebensmittelkontrolle und Veterinärwesen Lithuania: State Medicines Control Agency Luxembourg: Direction de la Santé Villa Louvigny Division de la Pharmacie et des Medicaments Malta: Medicines Authority Netherlands: Medicines Evaluation Board (MEB) College ter Beoordeling van Geneesmiddelen Norway: Norwegian Medicines Agency (Statens Legemiddelverk) Poland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: National Medicines and Health Products Authority (INFARMED) Romania: National Medicines Agency (NMA) Slovakia: State Institute for Drug Control (SIDC) Slovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency (MPA) Switzerland: Swissmedic, Schweizerisches Heilmittelinstitut Turkey: General Directorate of Medicines and Pharmaceutics Ukraine: National Agency on quality control and safety of food and medicinal products United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA) Heads of Medicines Agencies European Agency Medicines (EMEA) DG Enterprises - Pharmaceuticals - Regulatory Framework and Market Authorisations Australia: Australian Government Department of Health and Ageing (TGA) Canada: Health Canada - Health Products and Food Branch Japan: Ministry of Health, Labour and Welfare New Zealand: Ministry of Health USA: Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) South Africa: Medicines Control Council (MCC) Association of the British Pharmaceutical Industry (ABPI) Association of the European Self-Medication Industry (AESGP) BioIndustry Association (BIA) British Generic Manufacturers Association (BGMA) British Standards Industry Canadian Association of Professional Regulatory Affairs (CAPRA) Drug Information Association (DIA) European Directorate for the Quality of Medicines and Healthcare (EDQM) European Generic Medicines Association (EGA) European Federation of Pharmaceutical Industries and Associations (EFPIA) European Medical Technology Food Standards Agency International Federation of Pharmaceutical Manufacturers and Associates (IFPM) Institute for Clinical Research (ICR) Japanese Pharmaceutical Manufacturers Association (JPMA) nCADREAC - New Collaboration Agreement between Drug Regulatory Authorities in Central and Eastern European Countries National Institute for Health and Clinical Excellence (NICE) Pharmaceutical Information & Pharmacovigilance Association (PIPA) Pharmaceutical Research & Manufacturers of America (PhRMA) Proprietary Association of Great Britain (PAGB) Regulatory Affairs Professionals Society (RAPS) Royal Pharmaceutical Society of Great Britain The Organisation for Professionals in Regulatory Affairs (TOPRA) World Health Organisation DG Enterprises - Pharmaceuticals - Regulatory Framework and Market Authorisations Centralised Procedure Cosmetics Directives Herbals Medical Devices Directives Mutual Recognition Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h) Variations Orphan medicinal product designation in the EU The EU Paediatric Regulation EudraLex Volume 10: Directives 2001/20/EC, 2005/28/EC and Detailed Guidances European Clinical Trials Database Detailed Guidelines on the principles of good clinical practice in the conduct in the EU of clinical trials on medicinal products for human use NHS Research Ethics Committee Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use Guideline for Drug Master Files Recommendation on the content of the Trial Master File and archiving Clinical Trial Registries Standard Operating Procedures ICH Harmonized Tripartite Guideline E3: Structure and Content of Clinical Study Reports Investigator Brochures EU Clinical Trials Directive Investigational Medicinal Product Dossier (IMPD) Common Technical Document Electronic submissions (e-CTD) Labelling/packaging/SPC/PIL Variations Renewals EC Guideline on the Readability of the Label and Package Leaflet of Medicinal Products for Human Use EC Guidance concerning consultations with target patient groups for the package leaflet MHRA User testing of patient information leaflets Guidelines on Pharmacovigilance for Medicinal Products for Human Use EudraVigilance Council for International Organizations of Medical Sciences Annual Safety Reports: EU Clinical Trials Directive Periodic Safety Update Reports: ICH E2C Data Elements for Transmission of Individual Case Safety Reports: ICH E2B Development Safety Update Report (DSUR): Harmonizing the Format and Content for Periodic Safety Reporting During Clinical Trials (CIOMS VII) Benefit-Risk Balance for Marketed Drugs. Evaluating Safety Signals (CIOMS IV) Pharmacovigilance Planning Risk Management Plan Urgent Safety Restrictions National Institute for Health and Clinical Excellence Scottish Medicines Consortium All Wales Medicines Strategy Group EUnetHTA HTA Glossary Pricing and Reimbursement Working Group |