In the Zone: Research Regulations – China NMPA

Supporting new drug application submissions using manual data will become increasingly obsolete as electronic versions can offer increased efficiency, traceability and data preservation while simultaneously providing a comprehensive audit trail for companies navigating the drug development continuum.

Learn how Labcorp Bioanalytical Services has navigated the manual to electronic workbook transition in China to achieve NMPA approval for bioanalytical data submissions in 2022 in our In the Zone feature.


INFOGRAPHIC

Drug applications – the transition from manual to electronic – INZ CAR-TIn this infographic, we will explore how Labcorp has managed to navigate this digital transition and the use of electronic management systems.

 

 

 

INTERVIEW

podcastManual to electronic drug application submissions: an interview with Xiaoge Chen – In this interview, we explore how the changes from manual to electronic workbooks are being integrated in China and how this may reveal positive results for future digital implementation across the field.

 

 

 

RESOURCES

Bioanalysis Zone hexagon

Critical reagents in flow cytometry, instrumentation and application in drug discovery development

Chapter 5: Electronic notebooks: the paperless laboratory

Utilization of electronic resources in the NDA/BLA regulatory review of bioanalytical data: perspectives from US FDA reviewers

 

 

[Video by Kristian Baycroft-Willmott]


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