Experts from the adverse reaction monitoring center of the state general administration visited CHIPSCREEN BIOSCIENCES for research

November 23,2017

On the afternoon of November 23, 2017, Dong Duo, who is the minister of the chemical and biological products department of the adverse drug reaction monitoring center of the state general administration, and other experts and leaders, together with experts from Beijing adverse drug reaction monitoring center and Jiangsu adverse drug reaction monitoring center, accompanied by leaders and experts from Guangdong adverse drug reaction monitoring center and Shenzhen adverse drug reaction monitoring center, went to Shenzhen CHIPSCREEN BIOSCIENCES co., ltd. to carry out an investigation on the implementation of MAH drug alert main responsibility by enterprises.

Dr. Ning Zhiqiang, the executive vice president of clinical research and development of CHIPSCREEN BIOSCIENCES, and the person in charge of drug safety reported to the experts attending the meeting on the progress of clinical development of CHIPSCREEN BIOSCIENCES, the drug alert system, and the work of adverse reaction monitoring after the first original new drug Chidamide (Epidaza?) for the treatment of peripheral T-cell lymphoma in our country was put on the market. CHIPSCREEN BIOSCIENCES has established an active monitoring mode of dual information collection system based on China's actual situation and international conventions, which focuses on post-market monitoring of Chidamide. Currently, CHIPSCREEN BIOSCIENCES have completed the safety monitoring of about 3,000 patients. The results of the periodic analysis of active monitoring have been published in academic journals and conferences at home and abroad. The data of thousands of people accumulated by Chidamide's active monitoring is the largest data in the world's PTCL real-world research so far.



Experts at the meeting and relevant personnel of enterprise drug safety held heated discussions and in-depth exchanges on the key monitoring after the Chidamide was released on the market, and gave high praise to the drug alert work of CHIPSCREEN BIOSCIENCES.

CHIPSCREEN BIOSCIENCES is the first enterprise that has approved the drug listing holder and the entrusted production approval document with the drug production enterprise group's pilot policy of integrating technical resources since China launched the pilot policy of the drug listing permit holder. According to relevant national policies and regulations, the company has established a quality assurance system and a drug alert system to implement the main responsibilities of the whole chain of drug production and sales as well as the whole life cycle management of drugs. " Medicine is a special commodity that concerns human life and should be based on science rather than political, religious and commercial interests. " CHIPSCREEN BIOSCIENCES will continue to adhere to this principle, fulfill the legal main responsibility of the holders of the listing license, and provide accessible, safe, effective medicines of high quality for patients.

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