相关链接

 欧盟GMP

https://ec.europa.eu/health/documents/eudralex/vol-4_en

  EMA

https://www.ema.europa.eu/en

  EDQM

https://www.edqm.eu/en

  EDQM质量文件

https://www.edqm.eu/en/quality-management-guidelines-86.html

 欧盟GMP结果查询

http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do

 欧盟eCTD递交平台

https://cespportal.hma.eu/Account/Login?ReturnUrl=%2f

  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

https://www.picscheme.org/en/publications

  ISPE

http://www.ispe.org/ispe-news

  ISO

https://www.iso.org/standard/53394.html

  ICH

http://www.ich.org/home.html

  MHRA

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency


  NMPA

http://www.nmpa.gov.cn

  CNCA

http://www.cnca.gov.cn/

  CDE

http://www.cde.org.cn/welcome.do?method=execute