出口美国的产品，现在想增加一家原料药供应商。需要做哪些工作？申报流程是什么？...

冰封世界

如题

Aster205

前段时间帮客户做过类似的项目，需要做一个API comparability study，然后客户走的是补充申报

JL052

属于重要变更（增加原料药供应商）
需要充分的沟通，找代理商咨询相关的法律法规要求啊，产品剂型特点不一样，有不同的要求的吧

快活王

你的原料供应商是否已经提交了DMF文件，是否通过了FDA的检查？你这种情况不应当正常提交变更么？

beiwei5du

Q12: If you are an applicant submitting an ANDA with two API sources, are you required to perform stability on three batches of drug product for each API source?
A12: If you propose to add additional sources of API for the same drug substance, you should provide the following CMC information:
• Comparison and justification of comparability (by the applicant) of the physico-chemical properties and impurities of the drug substance from each source.
• Appropriate stability data on three batches of drug product qualifying the first API source used in the bioequivalence (BE) studies as recommended by the FDA stability guidance.
• A single pilot scale batch of the drug product bio-strength(s) manufactured using the second or each of the other proposed API source(s) used to support the ANDA application, along with comparative dissolution data.
• Appropriate stability data (accelerated and long-term for 6 months at the time of filing) on the strength(s) manufactured for each API source. Appropriate stability data may in some cases include intermediate condition stability data.
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm366082.pdf

小金库

谢谢分享。