Global regulations & guidance
Global regulations & guidance | |
Global regulations & guidance | https://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/ |
ICH | http://www.ich.org/products/guidelines.html |
PIC/S | https://www.picscheme.org/en/publications?tri=all |
Country specific regulations | |
FDA | https://www.fda.gov/RegulatoryInformation/Guidances/default.htm#browse |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm | |
https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl | |
EMA/ European Commission | https://ec.europa.eu/health/documents/eudralex_en |
https://ec.europa.eu/health/documents/eudralex/vol-4_en | |
https://www.ema.europa.eu/en/human-medicines-regulatory-information | |
ANVISA (Brazil) | http://portal.anvisa.gov.br/english#navigation |
Health Canada | https://www.canada.ca/en/health-canada/services/drugs-health-products.html |
CFDA (China) | |
TGA (Australian) | https://www.tga.gov.au/ |