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