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| - | ====== International Council for Harmonization ====== | ||
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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 " | ||
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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.((// | ||
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| - | Members include: | ||
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| - | * [[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]] | ||
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| - | ==== Observers ==== | ||
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| - | === Standing Observers === | ||
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| - | | [[International Federation of Pharmaceutical Manufacturers & Associations]] (IFPMA) | ||
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| - | === Legislative or Administrative Authorities === | ||
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| - | | [[Analytical Expertise Center]] of [[Azerbaijan]] | ||
| - | | [[Control Estatal de Medicamentos, | ||
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| - | === International Pharmaceutical Industry Organisations === | ||
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| - | | [[Active Pharmaceutical Ingredients Committee]] (APIC) | ||
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| - | === International Organisations regulated or affected by ICH Guideline(s) === | ||
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| - | | [[Bill & Melinda Gates Foundation]] (BMGF) | ||
| - | | [[International Pharmaceutical Excipients Council]] (IPEC) Federation | ||
| - | Co-operation Scheme]] (PIC/ | ||