Regulation and guidance
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International Conference on Harmonisation |
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The Federal Register The Code of Federal Regulations |
Societies
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Regulatory Affairs Professional Society |
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Drug Information Association |
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Society of Quality Assurance |
| References and Data Sources | |||
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Entrez is a search and retrieval system that integrates information from databases at the National Center for Biotechnology Information (NCBI) |
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Approved Drug Products |
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National Institutes of Health (NIH)
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The United States Pharmacopeia
http://www.healthfinder.gov/findservices/
try:
- BNF
- BNF for children
- National electronic library for medicines (formerly known as DrugInfoZone)
- Drug Digest Drug Interactions search
- electronic Medicines Compendium UK data sheets – SPCs & PILs for UK market
- Eudrapharm for all drugs registered under the common process (many are not !)
- FDA-CDER drug information including US data sheets which tend to be comprehensive
The Royal Pharmaceutical Society of Great Britain lists national websites as aid to identification of foreign medicines. Some of the sites require registration.
Product Category Definitions
Definitions of biological product, drug, device and combination products
- Biological product – section 351(a) of the Public Health Service Act [42 U.S.C. 262(i)] and 21 CFR 600.3(h)
- Drug – section 201(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(g)]
- Device – section 201(h) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(h)]
- Combination product – section 503(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C 353 (g)] and 21 CFR Part 3.2(e)
Small Molecule Drugs
Center for Drug Evaluation & Research (CDER) home page
www.fda.gov/cder/
Biologics
Center for Biologic Evaluation & Research (CBER) home page
www.fda.gov/cber
CBER guidance and guidelines
www.fda.gov/cber/guidelines.htm
Investigational new drug (IND) details and guidance documents
www.fda.gov/cder/regulatory/applications/ind_page_1.htm
Medical Devices
Device advice
www.fda.gov/cdrh
Information on exempt devices at the Centre for Device & Radiologic Health (CDRH)
www.fda.gov/cdrh/devadvice/3133.html
List of exempt devices
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
Classifying a device
www.fda.gov/cdrh/devadvice/313.html
Device classification database
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
510K guidance (“substantial equivalence”)
www.fda.gov/cdrh/devadvice/314.html
PMA guidance
www.fda.gov/cdrh/devadvice/pma/
Combination Products
Office of Combination Products (OCP)
www.fda.gov/oc/combination/
Assays & In Vitro Diadnostics (IVD)
In vitro diagnostics (OIVD/CDRH)
List of approved classified IVDs
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/showCFR.cfm
Assignment of CLIA categories
www.fda.gov/cdrh/clia/
Life Science Software
Software guidance document for validation
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm
Guidance on Smartphone applications in a healthcare setting
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm
Still can’t find what you are looking for? Try this last group of links:
Broad Search Categories
Code of Federal Regulations Title 21, 800-900 in particular
www.access.gpo.gov/nara/cfr/waisidx_00/21cfrv8_00.html
Search of all databases
www.fda.gov/search/databases.html
Food and Drug Cosmetic Act (US)
www.fda.gov/opacom/laws/fdcact/fdctoc.htm
International Clinical Harmonization (ICH) – caution this is not US specific
www.ich.org
Device recalls
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.
Europe
European Directorate for the Quality of Medicines
Andorra: Ministry of Health and Welfare
Austria: Ministry of Labor, Health and Social Affairs (in German)
Belgium: Ministry of Social Affairs, Public Health and the Environment (in Dutch)
Belgium: Pharmaceutical Inspectorate
Bulgaria: National Drug Institute
Republic of Cyprus: Ministry of Health
Czech Republic: Ministry of Health (in Czech)
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency (in Danish)
Denmark: Danish Medicines Agency (in English)
Denmark: Veterinary and Food Administration
Estonia: Ministry of Social Affairs
Estonia: State Agency of Medicines
Finland: Ministry of Social Affairs and Health
Finland: National Agency for Medicines
France: Ministry of Health (in French)
France: Sanitary Safety of Health Products Agency (in French)
Georgia: Ministry of Health Care
Germany: Ministry of Health (in German)
Germany: Federal Institute for Drugs and Medical Devices
Germany: Robert Koch Institute (in German)
Germany: Federal Institute of Consumer Health Protection and Veterinary Medicine
Greece: Ministry of Health and Welfare (in Greek)
Hungary: National Institute of Pharmacy
Iceland: Ministry of Health and Social Security
Ireland: Department of Health and Children
Italy: Ministry of Health (in Italian)
Italy: National Institute of Health
Italy: Ministry of Agricultural Policy (in Italian)
Latvia: State Agency of Medicines
Lithuania: State Medicines Control Agency
Luxembourg: Ministry of Health (in French)
Malta: Medicines Regulatory Unit
Netherlands: Ministry of Health, Welfare and Sport
Netherlands: Medicines Evaluation Board
Norway: Norwegian Board of Health
Poland: Ministry of Health and Social Security
Poland: Drug Institute (in Polish)
Portugal: Ministry of Health (in Portuguese)
Romania: National Medicines Agency
Portugal: National Institute of Pharmacy and Medicines (in Portuguese)
San Marino: Ministry of Health and Social Security (in Italian)
Slovak Republic: Ministry of Health
Slovak Republic: State Institute for Drug Control
Slovenia: Ministry of Public Health (in Slovenian)
Slovenia: Agency for Medicinal Products
Slovenia: Institute of Public Health
Spain: Ministry of Health and Consumption (in Spanish)
Sweden: Medical Products Agency
Sweden: National Board of Health and Welfare
Switzerland: Federal Office of Public Health (in French)
Switzerland: Intercantonal Office for Control of Medicaments
Switzerland: Federal Veterinary Office
Turkey: Ministry of Health (in Turkish)
Turkey: General Directorate of Medicines and Pharmaceutics (in Turkish)
Ukraine: Ministry of Agroindustrial Complex
UK: Medicines and Healthcare Products Regulatory Agency
Middle East
Egypt: Ministry of Health and Population
Asia/Oceania
Australia: Department of Health
Australia: Therapeutic Goods Administration
Azerbaijan Republic: Ministry of Health
China (PRC): Ministry of Health (in Chinese)
China (PRC): State Food and Drug Administration (in Chinese)
Hong Kong: Department of Health
India: Central Drugs Standard Control Organization
Japan: Ministry of Health and Welfare
Korea: Food and Drug Administration (in Korean)
Mongolia: Ministry of Health and Social Welfare
New Zealand: Ministry of Health
New Zealand: Medicines and Medical Devices Safety Authority
Papua New Guinea: Department of Health
Philippines: Ministry of Health
Sri Lanka: Ministry of Health, Highways & Social Services
Thailand: Ministry of Public Health
Thailand: Food and Drug Administration (in Thai)
Vietnam: Ministry of Health (under re-construction)
Africa
Algeria: Ministry of Health and Population
Mauritius: Ministry of Health & Quality of Life
Morocco: Ministry of Public Health (in French)
Namibia: Ministry Of Health And Social Services
Nigeria National Agency for Food and Drug Administration and Control
South Africa: Department of Health
Swaziland: Ministry of Health and Social Welfare
Tunisia: Ministry of Public Health
(in French)
Americas
Argentina: National Administration of Drugs, Foods and Medical Technology
(in Spanish)
Bahamas: Department of Environmental Health Services
Bolivia: Ministry of Health and Social Welfare (in Spanish)
Brazil: Ministry of Health (in Portuguese)
Brazil: Fundacao Oswaldo Cruz (in Portuguese)
Canada: Health Protection Branch
Chile: Health Ministry (in Spanish)
Chile: Institute of Public Health (in Spanish)
Colombia: Ministry of Health (in Spanish)
Costa Rica: Ministry of Health (in Spanish)
El Salvador: Ministry of Public Health and Social Assistance (in Spanish)
Guyana: National Bureau of Standards
Honduras: Ministry of Health (in Spanish)
Mexico: Ministry of Health (in Spanish)
Netherlands Antilles: Department of Public Health and Environmental Protection
Nicaragua: Ministry of Health (in Spanish)
Panama: Ministry of Health (in Spanish)
Panama: Ministry of Agricultural Development, Office of Plant Health
Paraguay: Ministry of Public Health and Social Welfare (in Spanish)
Peru: Ministry of Health (in Spanish)
Peru: General Directorate of Pharmaceuticals, Devices and Drugs (in Spanish)
Trinidad & Tobago: Bureau of Standards
Uruguay: Ministry of Public Health (in Spanish)
Venezuela: Ministry of Health and Social Development (in Spanish)
FDA Home Page
www.fda.gov
FDA Freedom of Information Index
www.fda.gov/foi/electrr.htm
FDA Warning Letters
www.fda.gov/foi/warning.htm
FDA Recalls
www.fda.gov/opacom/Enforce.html
FDA Inspection Guides
http://www.fda.gov/ora/inspect.ref/iglist.html
FDA Compliance References
http://www.fda.gov/ora/compliance.ref/default.htm
CFR Titles
www.access.gpo.gov/nara/cfr/cfr-table-search.html
U.S. Code
www.uscode.house.gov/usc.htm
CBER Guidelines
http://www.fda.gov/cher/guidelines.htm
CDER Guidelines
www.fda.gov/cder/guidance/index.htm
CDRH Guidelines
www.fda.gov/cdrh/ggpmain.html
CDRH Documents
www.fda.gov/cdrh/topindx.html
CGMP
www.fda.gov/cder/dmpq/index.htm
Investigation Operations Manual
www.fda.gov/ora/inspect_ref/iom/iomtc.html
FDA Medwatch (Medical Product Reporting Program)
www.fda.gov/medwatch
FDA Phone Book (Staff Directory & Search Program for Employees of HHS-includes email addresses)
directory.psc.gov/employee.htm
| USA | Food and Drug Association (FDA) www.fda.gov |
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| Europe | European Union Drug Regulatory Agency (Eudra) dg3.eudra.org |
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| EMEA www.emea.europa.eu |
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| Heads of Agencies for the European Union heads.medagencies.org |
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| UK | Medicines and Healthcare products Regulatory Agency (MHRA) www.mhra.gov.uk |
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| Germany | BfArM heads.medagencies.org/germany.html |
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| Portugal | Instituto Nacional da Farmácia e do Medicamento www.infarmed.pt/index2.html |
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| France | French Health Products Safety Agency agmed.sante.gouv.fr |
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| Spain | Agencia Española del Medicamento www.msc.es/agemed |
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| Belgium | http://www.afigp.fgov.be | |
| Norway | Norway Medicines Board www.legemiddelverket.no |
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| Sweden | Medical Products Agency www.mpa.se/eng/index.shtml |
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| Finland | National Agency for Medicines www.nam.fi/english/index.html |
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| Italy | Ministero della Salute www.ministerosalute.it/medicinali |
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| Netherlands | CBG www.cbg-meb.nl |
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| Australia | Therapeutic Goods Administration (TGA) www.tga.gov.au |
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| Bulgaria | Bulgarian Drug Agency www.bda.bg/web_engl/main.htm |
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| Canada | Therapeutic Products Directorate (TPD) www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng |
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| Chile | Chile Regulatory Agency www.minsal.cl |
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| Russia | Czech Republic www.sukl.cz/enindex.htm |
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| Denmark | The Danish Medicines Agency www.laegemiddelstyrelsen.dk/index_en.htm |
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| Estonia | State Agency of Medicines www.sam.ee |
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| Greece | EOD www.eof.gr |
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| Hong Kong | Hong Kong Department of Health Welfare and Food www.fwfb.gov.hk/eindex.html |
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| India | Ministry of health and family welfare mohfw.nic.in |
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| Ireland | Irish Medicine Board www.imb.ie |
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| Japan | Ministry of Health, Labour and Welfare (MHLW) www.mhlw.go.jp/english |
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| Russia | Ministry of Health of the Russian Federation www.minsalud.gov.com |
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| Switzerland | Swiss Medic www.swissmedic.ch |
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