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歐盟GMP |
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EMA |
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EDQM |
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EDQM質(zhì)量文件 |
https://www.edqm.eu/en/quality-management-guidelines-86.html |
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歐盟GMP結(jié)果查詢 |
http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do |
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歐盟eCTD遞交平臺(tái) |
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US DMF |
https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs |
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WHO指南 |
https://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/ |
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PIC/S |
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ISPE |
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ISO |
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ICH |
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MHRA |
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
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NMPA |
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CNCA |
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CDE |
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