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China: CFDA seeks feedback on drug data management practices

2018/01/10

CFDA has used the draft to plot out the process of assigning creators to data, tracing it through the system and archiving or destroying records. The process is intended to stop companies from taking the deliberate and inadvertent actions that have made the unreliability of data a recurring theme in regulatory warning letters in recent years. The agency mostly takes a descriptive, not prescriptive, approach to the systems it wants companies to put in place to avoid these problems. CFDA specifies only authorized personnel should be able to process and store data or access archives. The agency also expects accounts to be protected by strong passwords that are changed regularly. In keeping with many of its guidelines, CFDA is placing ultimate responsibility for the implementation of the data management practices on senior management. CFDA expects people in senior positions to create a culture of quality and make resources available to enable their employees to comply with the practices. This entails stopping business pressures from affecting work related to data reliability and providing relevant training to staff involved in good practices. The guidance places responsibilities on all other members of organizations. CFDA expects everyone to report any data reliability issues they discover. CFDA is accepting feedback on the draft until 5 February. More Information On RAPS

Draft Guidance (Chinese)