On May 17 to 18, 2018, the Uppsala Monitoring Center ( UMC ), WHO international drug monitoring cooperation agency, held the 40th anniversary celebration in Uppsala city, Sweden. The adverse reaction monitoring agencies from all over the world were invited to the meeting. As one of the two industrial representatives invited by the conference (JNJ of the United States and Chipscreen Biosciences of China ), the president and chief scientific officer of Chipscreen Biosciences attended the celebration meeting and gave a presentation on the theme " A Model for Future Pharmacovigilance Development in China ".
Chidamide tablet (Epidaza®) is an original anti-tumor new drug independently developed by the CHIPSCREEN BIOSCIENCES with global patent protection, which belongs to category 1.1 of chemicals. In December 2014, CFDA approved Chidamide to be listed for treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) according to conditional approval procedures.
At the beginning of the approval of the Chidamide tablet for listing, the China Food and Drug Administration Drug Review Center (CDE) and CHIPSCREEN BIOSCIENCES communicated with each other and made joint efforts, fully combining the Chinese reality and international conventions, and formulated a set of active monitoring plan with a dual information collection system. The two-channel post-marketing active monitoring plan jointly developed by CDE and CHIPSCREEN BIOSCIENCES was very successful. By the end of 2017, the Chidamide active monitoring plan had conducted safety monitoring on nearly 3500 patients, realizing the complete collection of adverse reactions in the real world, large coverage area and large patient population. It had sufficient sensitivity to discover new signals to maximize patient safety protection and minimize risk, which was highly evaluated by UMC Monitoring Center and participants.