Clarification Needed: NMPA Requirement for SAS XPORT Dataset Formats

Pinnacle 21 Support Troubleshooting and Problems
1

2 remarks:
A. For “open” formats, there is no such thing “or above”
B. SAS XPORT is not suitable for chinese language datasets, it is only suitable for US-ASCII only.

CDISC now has a much better format, which is CDISC “Dataset-JSON” (CDISC Dataset-JSON v1.1 Specification).
It is a matter of time that NMPA will switch to Dataset-JSON, especially due to the inability of XPT to take chinese characters.

2

Hi Chengeng,

Our blog post is outdated. SAS XPT v8 format is another option for NMPA submissions.

P21 Validator supports this format starting NMPA engine 2204.0.

Kind Regards,
Sergiy

3

I’ve come across some conflicting information regarding the dataset format requirements mandated by the NMPA. Specifically, the p21 blog (Preparing CDISC Submissions for China’s NMPA [Updated] | Pinnacle 21) I read states that the NMPA requires Chinese-language datasets to be in SAS XPORT V5 format. However, the official guidance (国家药监局药审中心关于发布《药物临床试验数据递交指导原则（试行）》的通告（2020年第16号）) I found mentions that datasets should be in V5 format or above.

I have a feeling the blog might be misleading. Please confirm.