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international_council_for_harmonization [2022/04/24 08:17]
liam [Observers]
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-====== International Council for Harmonization ====== 
  
-{{ ::ich-logo.png?200|}} 
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-The **International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use** (ICH) is a supra-national non-government organization "brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration." 
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-===== Affiliations ===== 
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-==== Members ==== 
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-ICH's membership consists of national regulatory bodies, non-governmental organizations and pharmaceutical industry interests. They are categorized into Members and Observers.((//Members & Observers.// (2019). International Coalition for Harmonisation. https://archive.ph/JNNaY)) 
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-=== Founding Regulatory Members === 
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-| [[European Commission]] (EC) and [[European Medicines Agency]] (EMA) | U.S. [[Food and Drug Administration]] (FDA) | [[Ministry of Health, Labour and Welfare]] (MHLW) and [[Pharmaceuticals and Medical Devices Agency]] (PMDA) of Japan  | 
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-=== Founding Industry Members === 
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-| [[European Federation of Pharmaceutical Industries and Associations]] (EFPIA)  | [[Japan Pharmaceutical Manufacturers Association]] (JPMA)  | [[Pharmaceutical Research and Manufacturers of America]] (PhRMA)  | 
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-=== Standing Regulatory Members === 
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-| [[Health Canada]]  | [[Swissmedic]]  | 
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-=== Regulatory Members === 
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-| [[Agência Nacional de Vigilância Sanitária]] (ANVISA)  | [[Comisión Federal para la Protección contra Riesgos Sanitarios]] (COFEPRIS)  | Singapore [[Health Sciences Authority]] (HSA)  | 
-| [[Ministry of Food and Drug Safety]] of [[South Korea]] (MFDS) | [[National Medical Products Administration]] of [[China]] (NMPA)  | [[Saudi Food & Drug Authority]] (SFDA)  | 
-| [[Taiwan Food and Drug Administration]] (TFDA)  | [[Turkish Medicines and Medical Devices Agency]]  | 
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-=== Industry Members === 
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-| [[Biotechnology Innovation Organization]] (BIO)  | [[Global Self-Care Federation]] (GSCF)  | [[International Generic and Biosimilar Medicines Association]] (IGBA)  | 
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-==== Observers ==== 
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-=== Standing Observers === 
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-| [[International Federation of Pharmaceutical Manufacturers & Associations]] (IFPMA)  | [[World Health Organization]] (WHO)  |  
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-=== Legislative or Administrative Authorities === 
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-| [[Analytical Expertise Center]] of [[Azerbaijan]]  | [[Administración Nacional de Medicamentos, Alimentos y Tecnología Médica]] of Argentina (ANMAT)  | [[Central Drugs Standard Control Organisation]] of India (CDSCO)  | 
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