Pharmacovigilance (PV) is going truly global, as most regulatory authorities across the world are making it mandatory to submit adverse event reports of international cases. Similarly, for manufacturers in China, there is a regulatory requirement of reporting any adverse event case received from outside China. For compliance with this requirement, the individual case safety reports (ICSRs) are required to be translated into Chinese before they are submitted to the National Medical Product Administration (NMPA, formerly CFDA).
Translation of safety reports is a complex challenge, as the safety information has to be captured precisely without any margin for discrepancies. There are multiple factors involved in the precise translation of reports such as understanding the local colloquialisms, abbreviations, and source documents. Specifically, safety narrative writing can be an extremely challenging task as narratives within individual case safety reports (ICSRs) are required to provide a complete medical story, particularly for serious cases and expedited reports with multiple sources of information. Auto-narrative generation tools can decrease the manual effort in preparing the narratives from scratch.
Translating the safety narratives manually is an equally tedious process as it requires a high degree of accuracy with the original narrative. ArisGlobal’s LifeSphere Safety MultiVigilance (LSSMV) database system has auto-translation capabilities that can translate narratives from English to Chinese and vice versa. The application uses an advanced machine-translation technology, which supports pharmacovigilance staff in efficient translation of narratives. Given the focus of this blog on Chinese PV, LSMV incorporates features for effectively capturing colloquialisms in Chinese, among other advanced features. These ensure higher consistency and accuracy of the translation.
LSMV provides multi-lingual support, therefore within a single database system PV staff can enter cases in different languages including medical coding using Chinese MedDRA. For instance, a drug-related adverse event reported in the US has to be reported to USFDA, however, if the drug in question is also approved in China, the report is also required to be submitted to NMPA in Chinese. LifeSphere Safety MultiVigilance supports entry of narratives both in English and Chinese within the same database system. Further, there is an option for side-by-side dual language panel display. This allows review and quality check of the translated case report with significantly less effort and also ensures a very low error rate.
Automated translation of narratives functionality in LifeSphere MultiVigilance is an auditable feature. Further, in the side-by-side dual language panel display feature, the data entered in both panels are audited and an audit trail can be generated. These audit trails will serve as an important source for manufacturers to demonstrate compliance with quality processes during inspections.
For more information, view our recent webcast ICH Regulation and Compliance in China: Get Ready for Tomorrow.