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Pharmas Turn to Oracle to Meet New Drug Safety Reporting Regulations in China
2018/6/26
source: Oracle
Luoxin Biotechnology (Shanghai) Co., Ltd. (¡°Luoxin Bio¡±) and Innovent Biologics, Inc. (¡°Innovent Bio¡±) have selected Oracle Argus to help them comply with new drug safety regulations and reporting in China.
 
 
Since 2018 the regulatory landscape for drug safety and pharmacovigilance in China has changed dramatically. The China Food and Drug Administration (CFDA) has been driving reforms to improve the quality of drugs and to encourage innovation in the development of new drugs and medical devices. This change is driving demand for pharmacovigilance and drug safety reporting solutions that can help pharmaceutical and medical device companies meet regulatory demands while shortening time to market for life-altering therapies.

Luoxin Bio has selected Oracle Argus to meet the FDA and CFDA¡¯s regulatory compliance on clinical report submissions for their international study. With Oracle Argus, Luoxin will have a single global safety database and an integrated workflow for superior safety reporting.

Innovent Bio selected Oracle Argus to eliminate manual processes associated with reporting its adverse events (AEs) and serious adverse events (SAEs). The company¡¯s pharmacovigilance team turned to Oracle Argus to eliminate manual data entry and potential errors on narrative drafting and to automatically track and support changing regulations in various global regions for timely reporting.

Oracle Argus is a comprehensive pharmacovigilance platform that enables biopharma companies to make faster and better safety decisions, optimize global compliance and integrate risk management into key processes.