Drug safety database can now be used by life sciences organizations that are looking to develop, manufacture, and market regulated products in the country.
AB Cube, who provides cloud software for life science multivigilance—including pharmacovigilance—revealed that its ICH E2B (R3)-compliant multivigilance software SafetyEasy Suite has successfully passed testing in China for the electronic transmission of individual case safety reports (ICSRs). The solution completed ICH E2B (R3) testing in China for a contract research organization (CRO) customer and has now been integrated into AB Cube’s software suite.
The SafetyEasy solution is now in general availability for all life science organizations who are developing, manufacturing, and marketing regulated products in the China market. According to Statista, China is currently the second largest pharmaceutical market in the world, with strong growth predicted over the next decade and a projected market value of US$575B for 2022.1
Since July 1 of last year, it has been mandatory for pharma manufacturers operating in China to submit all post-marketing adverse drug reaction reports in the ICH E2B R3 format adopted by the Chinese regulatory authorities. The ICH E2B (R3) guideline outlines the key requirements for electronic transmission of ICSRs, and provides specifications on mandated data elements for safety report submissions, from the clinical trial phase through to post-authorization.
“Following successful testing and confirmation of our full compliance with China’s E2B(R3) guidelines, we are delighted to now be offering our SafetyEasy Suite solution to customers with complete localization capabilities,” says Matthieu Doresse, AB Cube’s founder and CEO. “We look forward to bringing the benefits of our agile safety software to life science organizations of all sizes who are engaged in this region.”
Reference: Statista, Pharmaceutical market value in China in 2016 and 2022.