If an excipient of animal origin is used, such as gelatin or magnesium stearate, should a bovine spongiform encephalopathy (BSE) free certificate for the excipient be provide?

刊登日期:2019-11-12  |  點閱次數 : 352 次 

Yes, an excipient of animal origin may carry the risk of bovine spongiform encephalopathy agents, a BSE-free certificate for the excipient should be provided.



上一筆 Should the quantity, materials and types of container for the drug product to be
下一筆 When will the e-submission system be fully implemented for the new drug registrat