Avivia Pharmaceutical Links
Useful pharmaceutical links and pharmaceutical bookmarks of relevant pharmaceutical websites like WHO, ICH, EMA and FDA guidelines, databases, product links, national authorities, etc. The sites listed below are not maintained by the Avivia. Avivia can accept no responsibility for their content.
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Excipient Characterization Services
Experts in excipient analysis, reverse engineering, formulation support
National Authorities
- Argentina – ANMAT – Administración Nacional de Medicamentos Alimentos y Tecnología Médica
- Australia – TGA – Therapeutic Goods Administration
- Austria – AGES – Bundesamt für Sicherheit im Gesundheitswesen
- Belgium – AFMPS/FAGG – Federal Agency For Medicines and Health Products
- Brazil – ANVISA – Agencia Nacional de Vigilancia Sanitaria
- Bulgaria – BDA – The Bulgarian Drug Agency
- Canada – Health Canada
- Chile – ISP – Instituto de Salud Pública de Chile
- China – SFDA – State Food and Drug Administration
- Colombia – INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos
- Cyprus – Pharmaceutical Services
- Czech Republic – SUKL – State Institute for Drug Control
- Denmark – DHMA – Danish Health and Medicines Agency
- Estonia – SAM – State Agency of Medicines
- Finland – NAM – National Agency for Medicines
- France – AFSSAPS – Agence française de sécurité sanitaire des produits de santé
- Germany – BfArM – Federal Institute for Drugs and Medical Devices
- Greece – EOF – National Organization for Medicines
- Hungary – OGYI – Országos Gyógyszerészetl Intézet
- Iceland – IMCA – Icelandic Medicines Control Agency
- Ireland – IMB – Irish Medicines Board
- Israel – Ministry of Health
- Italy – AIFA – Agenzia Italiana del Farmaco
- Japan
- Korea – KFDA – Korea Food & Drug Administration
- Latvia – VZA – State Agency of Medicines
- Liechtenstein – Amt für Gesundheit
- Lithuania – VVKT – Valstybinee Vaistu Kontroles Tarnyba
- Luxembourg – Ministère de la Santé
- Malaysia – BPFK – Biro Pengalawan Farmaseutikal Kebangsan (National Pharmaceutical Control Bureau)
- Malta – Medicines Authority
- Mexico – COFEPRIS – Comisión Federal para la Protección contra Riesgos Sanitarios
- Netherlands – CBG/MEB – Medicines Evaluation Board
- New Zealand – Medsafe – New Zealand Medicines and Medical Devices Safety Authority
- Norway – Norwegian Medicines Agency
- Peru – DIGEMID – Dirección General de Medicamentos, Insumos y Drogas
- Poland – URPL – The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Portugal – INFARMED – National Pharmacy and Medicines Institute
- Romania – ANM – Agentia Nationala a Medicamentului
- Russia – Federal Service on Surveillance in Healthcare and Social Development of Russian Federation
- Singapore – HSA – Health Sciences Authority
- Slovakia – SUKL – State Institue for Drug Control
- Slovenia – JAZMP – Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
- South-Africa – MCC – Medicines Control Council
- Spain – AEMPS – Agencia Española de Medicamentos y Productos Sanitarios
- Sweden – MPA – Medical Products Agency
- Switzerland – SwissMedic – Schweizerisches Heilmittelinstitut
- Thailand – FDA – Food and Drug Administration
- Turkey – T.C. ilaç ve Eczacilik Genel Müdürlüğü
- Ukraine – State Expert Center
- Urugay – MSP – Ministerio de Salud Pública
- United Kingdom – MHRA – Medicines and Healthcare Products Regulatory Agency
- United States – FDA – Food and Drug Administration
Worldwide organisations
- WHO – World Health Organisation
- PAHO – Pan American Health Organisation
- WTO (TRIPS) – World Trade Organisation – TRIPS agreement
- RAPS – Regulatory Affairs Professionals Society
- ICH – International Conference on Harmonisation
- PIC/S – Pharmaceutical Inspection Co-operation Scheme
- List of participating countries
Approvals and Product Information
Europe
- EPAR
EMEA – European Public Assessment Reports on products given a Marketing Authorization in the EU via the Centralised procedure. - MRI index
CMD(h) – This Product Index includes medicines approved in the Member States of the European Union according to the procedure for Mutual Recognition or Decentralised. - EudraPharm / Article 57
EMEA – database on all medicines authorised in the European Economic Area (EEA). - The Community Register of medicinal products
EC – The Register of medicinal products for human use authorised in the EU under the Centralised procedure.
USA
- Orange Book
Approved Drug Products database, electronic Orange Book.
Includes Patent and Exclusivity info. - Drugs@FDA
- Orphan designations – Database of products granted orphan status
National
- Argentina
- Spanish – Medicinal products database
- Spanish – Other databases
- Australia
- eBS Australian Register of Therapeutic Goods – Medicines
- Background info on the database
- PL/SmPC database – PBS
- eBS Australian Register of Therapeutic Goods – Medicines
- Austria
- German – Arzneispezialitätenregister / PharmaIS Web (Licenses)
- Belgium
- Brazil
- Farmacopeia
- Portugese – Database
- Bulgaria
- Bulgarian – Register
- Canada
- DPD – Drug Product Database
- Chile
- Spanish – Database
- Colombia
- Spanish – Registros Sanitarios
- Croatia
- English – Database
- Czech Republic
- Czech – Database
- Cyprus
- Cypriotic/English – Database
- Denmark
- Danish – SmPC
- Finland
- English – FIMEA Web search
- France
- Germany
- German – DIMDI (Free AMIS database – Limited public information)
- German – Rote Liste
- German – Gelbe Liste – Background info on approved products in German
- Greece
- Greek/English – Database
- Hungary
- Iceland
- Icelandic – Medicinal Product Information
- Ireland
- Human Medicines Products List – Irish Medicines Board
- IPHA Medicines Compendium (SmPC / PL)
- Israel
- Italy
- Procedures database
- Italian – Gazzetta Ufficiale
- Japan
- English – database
- Latvia
- English – Database
- Lithuania
- Register of Medicinal Products – Search database
- Malaysia
- English – List of Registered Products
- Malta
- Mexico
- Spanish – Website
- Spanish – List of reference products – December 2021
- Netherlands
- New Zealand
- Medsafe Database
- Norway
- Norwegian – Legemiddelsøk
- Poland
- Polish – Database for finding SmPCs
- Polish – List of Approved Products
- Portugal
- Romania
- Romanian – Database
- Russia
- Russian – RegMed
- Singapore
- English – InfoSearch – Medicinal Products
- Slovenia
- Slovenian – BPZ online
- Note: “active substance” = “ucinkovina” and “product name” = “Ime zdravila”
- Slovenian – BPZ online
- Slovakia
- South Africa
- Spain
- Sweden
- Swedish – Database search
- FASS
- Switzerland
- Turkey
- Turkish – SmPC (Lists only recently approved products)
- Ukraine
- Ukrainian – Database
- United Kingdom
- electronic Medicines Compendium (eMC – You can also do full text searches in all SmPC and PL documents)
- Public Assessment Reports
