NMPA

Pinnacle 21 is happy to announce the latest Validation Engines for submissions to Japan PMDA, US FDA, and China NMPA!

P21 has invested much in developing these engines for/with regulatory agencies, and now the industry—whether as users of P21 Community (P21C) or clients of P21 Enterprise (P21E)—can utilize them for expanded standards support, e.g., the first time PMDA has implemented ADaMIG 1.2 & 1.3 and Define-XML 2.1, in their eData submissions to the the global regulatory bodies.

Key details are as follows:

(Originally published on October 6, 2020. Last Updated on October 30, 2020)

Effective October 1st, 2020, China’s NMPA will accept CDISC submissions. To support this initiative, Pinnacle 21 has released a new Chinese-language validation engine, available now in both Enterprise and Community. This engine supports datasets with Chinese-encoded characters and displays rule messages and descriptions in Chinese translation.