AUTHOR OF THIS BLOG

DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER

Regulation and guidance

 
International Conference on Harmonisation
The Federal Register The Code of Federal Regulations

Societies

Regulatory Affairs Professional Society
Drug Information Association
Society of Quality Assurance
References and Data Sources

Entrez – PubMed

Entrez is a search and retrieval system that integrates information from databases at the National Center for Biotechnology Information (NCBI)

Approved Drug Products


Electronic Orange Book
Approved Drug Products 
with Therapeutic Equivalence Evaluations
New and Generic Drug Approvals
This newly approved or tentatively approved drug 
listing is an interim page intended to provide timely
information on new drug products as a more
comprehensive page is developed.

National Institutes of Health (NIH)

The United States Pharmacopeia

http://www.cdc.gov/

http://www.healthfinder.gov/findservices/

logo Merck Medicus

http://www.merckmedicus.com/

Agency for Healthcare Research Quality

http://www.guideline.gov/

The Silver Book: Chronic<br /><br /><br /> Disease and Medical Innovation in an Aging Nation

http://www.silverbook.org/

National Institutes of Health (NIH) - Turning Discovery Into Health

http://www.nih.gov/

MediLexicon Logo
graphical logo of Heads of Medical Agencies
…………………………………………………………………………………………………….

try:

60px-Flag of EU.png

  • Eudrapharm for all drugs registered under the common process (many are not !)
Flag of USA.png

Flag of Australia.png

All government-subsidised medications available in Australia.

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

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 Medicines Agency

Europe: Head of Agencies

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

Croatia: Ministry of Health

Republic of Cyprus: Ministry of Health

Czech Republic: Ministry of Health (in Czech)

Czech Republic: State Institute for Drug Control

Denmark: Ministry of Health

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: Ministry of Health

Hungary: National Institute of Pharmacy

Iceland: Ministry of Health and Social Security

Ireland: Department of Health and Children

Ireland: Medicines Board

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: Ministry of Health

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)

Spain: Spanish Drug Agency

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 Health

Ukraine: Ministry of Agroindustrial Complex

UK: Ministry of Health

UK: Medicines and Healthcare Products Regulatory Agency

Middle East

Bahrain: Ministry of Health

Egypt: Ministry of Health and Population

Israel: Ministry of Health

Jordan: Ministry of Health

Lebanon: Ministry of Health

Palestinian Authority: Ministry of Health

United Arab Emirates: Ministry of Health




Asia/Oceania

Australia: Department of Health

Australia: Therapeutic Goods Administration

Azerbaijan Republic: Ministry of Health

Brunei: Ministry of Health

China (PRC): Ministry of Health (in Chinese)

China (PRC): State Food and Drug Administration (in Chinese)

Fiji: Ministry of Health

Hong Kong: Department of Health

India: Central Drugs Standard Control Organization

Indonesia: Ministry of Health

Japan: Ministry of Health and Welfare

Korea: Food and Drug Administration (in Korean)

Malaysia: Ministry of Health

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

Singapore: Ministry of Health

Sri Lanka: Ministry of Health, Highways & Social Services

Taiwan: Department of Health

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

Bahrain: Ministry of Health

Botswana: Ministry of Health

Kenya: Ministry of Health

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)

Zambia: Ministry of Health

Zimbabwe: Ministry of Health

Americas

Argentina: National Administration of Drugs, Foods and Medical Technology
(in Spanish)

Bahamas: Department of Environmental Health Services

Belize: Ministry of Health

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: Ministry of Health

Guyana: National Bureau of Standards

Honduras: Ministry of Health (in Spanish)

Jamaica: Ministry of Health

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

United States

Uruguay: Ministry of Public Health (in Spanish)

Venezuela: Ministry of Health and Social Development (in Spanish)

FDA Regulatory Links

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
Europe European Union Drug Regulatory Agency (Eudra)
dg3.eudra.org
EMEA
www.emea.europa.eu
Heads of Agencies for the European Union
heads.medagencies.org
UK Medicines and Healthcare products Regulatory Agency (MHRA)
www.mhra.gov.uk
Germany BfArM
heads.medagencies.org/germany.html
Portugal Instituto Nacional da Farmácia e do Medicamento
www.infarmed.pt/index2.html
France French Health Products Safety Agency
agmed.sante.gouv.fr
Spain Agencia Española del Medicamento
www.msc.es/agemed
Belgium http://www.afigp.fgov.be
Norway Norway Medicines Board
www.legemiddelverket.no
Sweden Medical Products Agency
www.mpa.se/eng/index.shtml
Finland National Agency for Medicines
www.nam.fi/english/index.html
Italy Ministero della Salute
www.ministerosalute.it/medicinali
Netherlands CBG
www.cbg-meb.nl
Australia Therapeutic Goods Administration (TGA)
www.tga.gov.au
Bulgaria Bulgarian Drug Agency
www.bda.bg/web_engl/main.htm
Canada Therapeutic Products Directorate (TPD)
www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng
Chile Chile Regulatory Agency
www.minsal.cl
Russia Czech Republic
www.sukl.cz/enindex.htm
Denmark The Danish Medicines Agency
www.laegemiddelstyrelsen.dk/index_en.htm
Estonia State Agency of Medicines
www.sam.ee
Greece EOD
www.eof.gr
Hong Kong Hong Kong Department of Health Welfare and Food
www.fwfb.gov.hk/eindex.html
India Ministry of health and family welfare
mohfw.nic.in
Ireland Irish Medicine Board
www.imb.ie
Japan Ministry of Health, Labour and Welfare (MHLW)
www.mhlw.go.jp/english
Russia Ministry of Health of the Russian Federation
www.minsalud.gov.com
Switzerland Swiss Medic
www.swissmedic.ch
UNITED STATES OF AMERICA (USA) :
United States Food and Drug Administration (US FDA):
US FDA: Home Page
US FDA: Center for Drug Evaluation and Research (CDER)
US FDA: CDER Guidance Documents
US FDA: Center for Biologics Evaluation and Research (CBER)
US FDA: CBER Guidance Documents
US FDA: Abbreviated New Drug Application (ANDA) Process for Generic Drugs
US FDA: Current Good Manufacturing Practices (cGMP) Regulations (21 CFR Parts 210 and 211)
US FDA: Drug Master Files (DMF guidance and DMF Database)
US FDA: Center for Devices and Radiological Health (CDRH)
US FDA: CDRH Regulatory and Marketing Advice for Medical Devices
AMERICAS :
CANADA:
Health Canada: Home Page (in English and French)
Health Canada: Health Products and Food Branch
Health Canada: Legislation and Guidelines – Drugs and Health Products – Main Page
Health Canada: Therapeutic Products DirectorateLATIN AMERICA:
Argentina: Ministry of Health (in Spanish)
Argentina: National Administration of Drugs, Foods and Medical Technology (in Spanish)
Bolivia: Ministry of Health and Social Welfare (in Spanish)
Chile: Health Ministry (in Spanish)
Chile: Institute of Public Health (in Spanish)
Colombia: Ministry of Health (in Spanish)
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos (in Spanish)
Ecuador: Ministry of Public Health (in Spanish)
El Salvador: Ministry of Public Health and Social Assistance (in Spanish)
Guatemala: Ministry of Health (in Spanish)
Guyana: Ministry of Health
Guyana: National Bureau of Standards
Jamaica: Ministry of Health
Mexico: Ministry of Health (in Spanish)
Mexico: Federal Commission for Protection against Health Risks (in Spanish)
Nicaragua: Ministry of Health (in Spanish)
Panama: Ministry of Health (in Spanish)
Peru: Ministry of Health (in Spanish)
Peru: General Directorate of Pharmaceuticals, Devices and Drugs (in Spanish)
Trinidad and Tobago: Ministry of Health
Trinidad & Tobago: Bureau of Standards
Uruguay: Ministry of Public Health (in Spanish)
EUROPEAN UNION (EU) :

European Medicines Agency (EMEA):

EMEA : Home Page

EudraLex : The Rules Governing Medicinal Products in the European Union
(including Notice to Applicants, Good Manufacturing Practices,
and other Guidelines for Human and Veterinary Medicinal Products)European Directorate for the Quality of Medicines and Healthcare (EDQM):
EDQM: Home Page
EDQM: Certification of Pharmaceutical Substances – News and General Information
on APIs and Excipients, Certificate of Suitability (CEP) Database
EUROPEAN NATIONAL AUTHORITIES :
GERMANY:
Germany: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices (BfARM)
Germany: Robert Koch Institute (in German)
Germany: Paul Ehrlich Institute (in German)
Germany: Federal Institute for Risk AssessmentUNITED KINGDOM:
UK: Department of Health
UK: Health Protection Agency
UK: Medicines and Healthcare products Regulatory Agency
UK: National Institute for Biological Standards and Control
UK: Veterinary Medicines DirectorateFRANCE:
France: Ministry of Health (in French)
France: Sanitary Safety of Health Products Agency – AFSSAPS (in French)
France: National Agency for Veterinary Medicinal ProductsITALY:
Italy: Ministry of Health (in Italian)
Italy: National Institute of Health

SPAIN:
Spain: Ministry of Health and Consumption
Spain: Spanish Agency of Medicinal Products

SWITZERLAND:
Switzerland: Federal Office of Public Health
Switzerland: Agency for Therapeutic Products (SWISSMEDIC)
Switzerland: Federal Veterinary Office

OTHER EUROPEAN NATIONAL AUTHORITIES:

Austria: Federal Ministry of Labour, Health and Social Affairs (in German)
Belgium: Ministry of Social Affairs, Public Health and the Environment
Belgium: Pharmaceutical Inspectorate
Bulgaria: Ministry of Health (in Bulgarian)
Bulgaria: Drug Agency
Croatia: Ministry of Health
Czech Republic: Ministry of Health (in Czech)
Czech Republic: State Institute for Drug Control
Denmark: Ministry of Health
Denmark: Medicines Agency
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
Greece: Ministry of Health and Welfare (in Greek)
Greece: National Organization for Medicines
Hungary: Ministry of Health
Hungary: National Institute of Pharmacy
Iceland: Ministry of Health and Social Security
Iceland: Medicines Control Agency
Ireland: Department of Health and Children
Ireland: Medicines Board
Latvia: State Agency of Medicines
Lithuania: State Medicines Control Agency
Luxembourg: Ministry of Health (in French)
Malta: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
Netherlands: Medicines Evaluation Board
Norway: Ministry of Health and Care Services
Norway: Norwegian Medicines Agency (in Norwegian and English)
Poland: Ministry of Health and Social Security (in Polish)
Poland: National Medicines Institute
Portugal: Ministry of Health (in Portuguese)
Portugal: National Institute of Pharmacy and Medicines (in Portuguese and English)
Romania: Ministry of Health and the Family (in Romanian)
San Marino: Ministry of Health and Social Security (in Italian)
Slovak Republic: Ministry of Health (in Slovak and English)
Slovak Republic: State Institute for Drug Control
Slovak Republic: State Veterinary and Food Administration (in Slovak)
Slovenia: Ministry of Health
Sweden: Medical Products Agency (in Swedish and English)
Turkey: Ministry of Health (in Turkish and English)
Ukraine: Ministry of Health (in Ukrainian, English and Russian)

BRAZIL, RUSSIA, INDIA AND CHINA (BRIC) :
BRAZIL:
Brazil: Ministry of Health (in Portuguese)
Brazil: National Health Surveillance Agency (ANVISA)
Brazil: Oswaldo Cruz FoundationRUSSIAN FEDERATION:
Russian Federation: Mednet (in Russian)
Russian Federation: Ministry of Health and Social Development (in Russian)INDIA:
India: Ministry of Health and Family Welfare
India: Central Drug Standards Control Organisation (CDSCO)
India: Drugs & Cosmetic Act & Rules (PDF, 8.76 MB)
India: Notifications of Amendments to the Drugs & Cosmetic Act & Rules
India: Good Manufacturing Practices – Schedule M (PDF, 280 KB)
India: Good Clinical Practice Regulation – Schedule Y
India: Guidelines for Import and Manufacture of Medical Devices
India: List of State Drugs Control OrganizationsCHINA:
China: General Administration of Quality Supervision, Inspection and Quarantine
China: Ministry of Health (in Chinese)
China: State Food and Drug Administration (SFDA)
China: National Institute for the Control of Pharmaceutical and Biological Products (in Chinese)
ASIA – PACIFIC :
JAPAN:
Japan: Ministry of Health, Labour and Welfare (MHLW)
Japan: Pharmaceuticals and Medical Devices Agency (PMDA)AUSTRALIA AND NEW ZEALAND:
Australia New Zealand Therapeutic Products Authority (ANZTPA)
(This project is on hold for now, but the site has a lot of useful information)
Australia: Department of Health
Australia: Therapeutic Goods Administration (TGA)
Australia: Pesticides & Veterinary Medicines Authority (APVMA)
New Zealand: Ministry of Health
New Zealand: Medicines and Medical Devices Safety Authority (MEDSAFE)OTHER ASIA-PACIFIC NATIONAL AUTHORITIES:
Bangladesh:Ministry of Health And Family Welfare
Brunei: Ministry of Health
Fiji: Ministry of Health
Hong Kong: Department of Health
Indonesia: Ministry of Health
Korea: Food and Drug Administration (KFDA)
Malaysia: Ministry of Health
Malaysia: National Pharmaceutical Control Bureau
Nepal: Ministry of Health and Population
Nepal: Department of Drug Administration
Pakistan: Ministry of Health Portal
Pakistan: Drugs Control Organization
Papua New Guinea: Department of Health
Philippines: Department of Health
Singapore: Ministry of Health
Singapore: Health Sciences Authority
Singapore: Agri-food and Veterinary Authority
Sri Lanka: Ministry of Health
Taiwan: Department of Health
Taiwan: National Laboratories of Foods and Drugs
Thailand: Ministry of Public Health (in Thai)
Thailand: Food and Drug Administration
Vietnam: Ministry of Health
MIDDLE EAST :
Bahrain: Ministry of Health
Israel: Ministry of Health
Israel: Ministry of Health – Pharmaceutical Administration
Jordan: Ministry of Health
Lebanon: Ministry of Public Health
Palestinian Authority: Ministry of Health
Saudi Arabia: Ministry of Health
United Arab Emirates: Ministry of Health (New site, not yet fully functional)
United Arab Emirates: Federal Department of Medicines and Pharmacy Control (New site, not yet functional)
United Arab Emirates: Ministry of Health – Old site, still functional
United Arab Emirates: Federal Department of Medicines and Pharmacy Control – Old site, still functional
AFRICA :
REPUBLIC OF SOUTH AFRICA:
South Africa: Department of Health
South Africa: Medicines Control Council (MCC) – Links to all Guidelines for Licensing, Registration, GMP, etc), are listed under “Documents” on this page.OTHER AFRICAN NATIONAL AUTHORITIES:
Botswana: Ministry of Health
Ghana: Ministry of Health
Kenya: Ministry of Health
Maldives: Ministry of Health
Mauritius: Ministry of Health & Quality of Life
Morocco: Ministry of Public Health (in French)
Namibia: Ministry of Health and Social Services
Senegal: Ministry of Health, Hygiene and Prevention (in French)
Swaziland: Ministry of Health and Social Welfare
Tanzania: Ministry of Health
Tunisia: Ministry of Public Health (in French)
Tunisia: Office of Pharmacy and Medicines (in French and Arabic)
Uganda: Ministry of Health

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