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Clarification Needed: NMPA Requirement for SAS XPORT Dataset Formats
Forums: Troubleshooting and Problems
NMPA Requirement for SAS XPORT
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" (https://cdisc-org.github.io/DataExchange-DatasetJson/doc/dataset-json1-1.html).
It is a matter of time that NMPA will switch to Dataset-JSON, especially due to the inability of XPT to take chinese characters.
SergiySAS XPT v8 format is another option
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Our blog post is outdated.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
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.