在什么情况下注册人可以提交与联合提交的其他成员部分或全部不同的数据？

在什么情况下注册人可以提交与联合提交的其他成员部分或全部不同的数据？

Under what circumstances can a registrant submit partially or fully separate data from other members of the joint submission?

注册人必须始终在联合提交的框架内提交其信息。但是，如果出现以下情况，注册人可以单独提交部分信息：联合提交部分信息的成本过高；或联合提交信息会导致商业敏感信息泄露，从而可能造成重大商业损害；或注册人与主要注册人就信息选择存在分歧。符合上述任何一种情况的注册人可以自行提交部分或全部数据：这分别称为部分退出和完全退出。退出的技术实现方式详见问答 396。

Registrants must always submit their information within the framework of a joint submission. However, registrants can submit some information separately, if:  it would be disproportionately costly for them to submit some information jointly, or submitting the information jointly would lead to the disclosure of commercially sensitive information that would likely cause substantial commercial detriment, or they disagree with the lead registrant on the selection of information. Registrants who fall under any of the above circumstances can submit some or all data on their own: these are respectively called partial and full opt-out. Technical implementation of the opt-out is described in Q&A 396.