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GHTF Archived Documents

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GHTF Archives

  • GHTF Mission Summary
  • GHTF History
  • GHTF Organisational Structure
  • GHTF Study Groups
  • GHTF Archived Documents
    • GHTF Steering Committee Documents
    • GHTF Study Group 1 - Pre-market Evaluation documents
    • GHTF Study Group 2 - Post-market Surveillance/Vigilance Documents
    • GHTF Study Group 3 - Quality Systems Documents
    • GHTF Study Group 4 - Auditing Documents
    • GHTF Study Group 5 - Clinical Safety/Performance Documents

This page provides access to archived GHTF documents only. Not all documents generated by GHTF are featured in this archive.

For a list of final GHTF documents, see the GHTF final documents page.

  • GHTF Steering Committee documents
  • GHTF Study Group 1 - Pre-market Evaluation documents
  • GHTF Study Group 2 - Post-market Surveillance/Vigilance documents
  • GHTF Study Group 3 - Quality Systems documents
  • GHTF Study Group 4 - Auditing documents
  • GHTF Study Group 5 - Clinical Safety/Performance documents

Member sites

Therapeutic Goods Administration

Brazilian Health Regulatory Agency (ANVISA)

Health Canada

National Medical Products Administration

European Commission - Directorate-General for Health and Food Safety

Pharmaceutical and Medical Devices Agency (PMDA)

Russian Ministry of Health

Health Sciences Authority

Ministry of Food and Drug Safety

Medicines and Healthcare products Regulatory Agency

US Food and Drug Administration

Swissmedic

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

Pan American Health Organization (PAHO)

African Medical Devices Forum (AMDF)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

The World Health Organization (WHO)

Saudi Arabia, Saudi Food and Drug Authority

Affiliate members

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

Costa Rica - Ministry of Health

Cuba - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)

Dominican Republic - General Directorate of Medicines, Food and Health Products (DIGEMAPS)

Egypt - Egyptian Drug Authority  (EDA)

El Salvador - Sanitary Regulation Superintendency (SRS)

Ethiopia - Ethiopian Food and Drug Authority (EFDA)

India - Central Drugs Standard Control Organization (CDSCO)

Israel - The Medical Technology, Health Information, Innovation and Research Directorate (MTIIR)

Affiliates

 

Jordan - Jordan Food and Drug Administration (JFDA)

Kenya - Pharmacy and Poisons Board (PPB)

Malaysia - Medical Device Authority (MDA)

Mexico - Federal Commission for Protection from Sanitary Risks (COFEPRIS)

Montenegro - Institute for Medicine and Medical Devices of Montenegro (CINMED)

Nigeria - National Agency for Food and Drug Administration Control (NAFDAC)

Oman - Drug Safety Center, Medical Device Control Department (DSC)

Paraguay - National Health Surveillance (DINAVISA)

Peru - General Directorate of Medicines, Supplies and Drugs (DIGEMID)

South Africa - South African Health Products Regulatory Authority (SAHPRA)

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

Uzbekistan - The Center for Pharmaceutical Products Safety 

Zanzibar - Zanzibar Food and Drug Agency (ZFDA)

Zimbabwe - Medicines Control Authority (MCAZ)

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