AUTHOR OF THIS BLOG

DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER

GMP

 

Links to Worldwide GMP Codes and Regulations

International Regulatory Links

The main prerequisite to work under cGMP is the right knowledge and understanding of the actual pharmaceutical regulations related to the specific sales market. This page summarizes the relevant links to regulatory agencies.

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

Below are links to the main international and national GMP Codes (Directives, Regulations) worldwide:

International Conference on Harmonization (ICH):
ICH Home Page
ICH Guidelines – Quality, Safety, Efficacy, Multidisciplinary,
including Common Technical Document (CTD) and Electronic Common Technical Document: (eCTD)

World Health Organization (WHO):
WHO: Home Page
WHO: Medicines (Medicines Policy and Standards…)
WHO: Medicines: Quality Assurance – Links to WHO Guidelines, including WHO GMP
WHO: Certification Scheme for the Quality of Pharmaceuticals
WHO: Prequalification Programme

World Trade Organization (WTO):
WTO: Home Page
WTO: TRIPS Gateway (Trade-Related Aspects of Intellectual Property Rights)

World Intellectual Property Organization (WIPO):
WIPO: Home Page
WIPO: Patent Search

Free Patents Online:
Free Patent Search, Free Patent PDF Downloads, Free Intellectual Property Alerts

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

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 HealthSPAIN:
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

…………………………………….

DR ANTHONY MELVIN CRASTO Ph.D , Born in Mumbai in 1964 and graduated from Mumbai University, Completed his PhD from ICT ,1991, Mumbai, India in Organic chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues,

Currently he is working with GLENMARK- GENERICS LTD, Research centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India.

Prior to joining Glenmark, he worked with major multinationals like Hoechst Marion Roussel, now Sanofi Aventis, & Searle India ltd, now Rpg lifesciences, etc. He has worked in Basic research, Neutraceuticals, Natural products, Flavors, Fragrances, Pheromones, Vet Drugs, Drugs, formulation, GMP etc. He has total 25 yrs exp in this field, he is now helping millions, has million hits on google on all organic chemistry websites.

His New Drug Approvals , Green Chemistry International, Eurekamoments in Organic Chemistry , Organic Chemistry by Dr Anthony, WIX BLOG , are some most read chemistry blogs

He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 25 year tenure, good knowledge of IPM, GMP, Regulatory aspects, he has several international drug patents published worldwide .

He has good proficiency in Technology Transfer, Spectroscopy , Stereochemistry , Synthesis, Reactions in Org Chem , Polymorphism, Pharmaceuticals , Medicinal chemistry , Organic chemistry literature , Patent related site , Green chemistry , Reagents , R & D , Molecules , Heterocyclic chem , Sourcing etc

He suffered a paralytic stroke in dec 2007 and is bound to a wheelchair, this seems to have injected feul in him to help chemists around the world, he is more active than before and is pushing boundaries, he has one lakh connections on all networking sites, He makes himself available to all, contact him on +91 9323115463, amcrasto@gmail.com

wheelchair

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