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international_council_for_harmonization [2023/03/12 05:58]
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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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-Members include: 
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-<WRAP column col4> 
-  * [[Agência Nacional de Vigilância Sanitária]] (ANVISA) 
-  * [[Biotechnology Innovation Organization]] (BIO) 
-  * [[Comisión Federal para la Protección contra Riesgos Sanitarios]] (COFEPRIS) 
-  * [[European Commission]] 
-  * [[European Federation of Pharmaceutical Industries and Associations]] (EFPIA) 
-  * [[European Medicines Agency]] (EMA) 
-  * [[Food and Drug Administration]] (FDA) 
-  * [[Global Self-Care Federation]] (GSCF)  
-  * [[Health Canada]] 
-  * [[Health Sciences Authority]] (HSA) 
-  * [[International Generic and Biosimilar Medicines Association]] (IGBA) 
-  * [[Japan Pharmaceutical Manufacturers Association]] (JPMA) 
-  * [[Ministry of Food and Drug Safety of the Republic of Korea]] (MFDS) 
-  * [[Ministry of Health, Labour and Welfare of Japan]] (MHLW) 
-  * [[National Medical Products Administration]] (NMPA) 
-  * [[Pharmaceutical Research and Manufacturers of America]] (PhRMA) 
-  * [[Pharmaceuticals and Medical Devices Agency]] (PMDA) 
-  * [[Saudi Food & Drug Authority]] (SFDA) 
-  * [[Swissmedic]]  
-  * [[Taiwan Food and Drug Administration]] (TFDA) 
-  * [[Turkish Medicines and Medical Devices Agency]] 
-</WRAP> 
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-==== Observers ==== 
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-Observers include: 
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-<WRAP column col4> 
-  * [[Active Pharmaceutical Ingredients Committee]] (APIC) 
-  * [[Administración Nacional de Medicamentos, Alimentos y Tecnología Médica]] (ANMAT) 
-  * [[Bill & Melinda Gates Foundation]] (BMGF) 
-  * [[Center for Analytical Expertise]] 
-  * [[Central Drugs Standard Control Organisation]] (CDSCO) 
-  * [[Control Estatal de Medicamentos, Equipos y Dispositivos Médicos]] (CECMED) 
-  * [[Council for International Organizations of Medical Sciences]] (CIOMS) 
-  * [[European Directorate for the Quality of Medicines & HealthCare]] (EDQM) 
-  * [[International Federation of Pharmaceutical Manufacturers & Associations]] (IFPMA) 
-  * [[International Pharmaceutical Excipients Council Federation]] 
-  * [[Pharmaceutical Inspection Co-operation Scheme]] (PIC/S) 
-  * [[United States Pharmacopeia]] (USP) 
-  * [[World Health Organization]] (WHO) 
-</WRAP> 
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