Major regulatory reforms for drugs and medical devices are being initiated in China to ensure safe, innovative, effective and high-quality medicinal products are available to its population. As part of this initiative, China has joined ICH in 2017 and has recently adopted several guidelines from ICH. These guidelines provide a framework to manufacturers for collecting, processing, archiving and reporting drug-related safety events during drug development and post-licensure and harmonize the data standards internationally with other leading health authorities. In order to achieve compliance with safety data management and electronic transmission standards, the manufacturers are required to adopt electronic safety database systems.
This whitepaper examines and addresses: