Center for Drug Evaluation of CFDA surveyed CMBA about biosimilar medicine policy
2014-04-23
Center for Drug Evaluation of CFDA came to CMBA to survey the policy of biosimilar medicine on April 17, 2014. The vice director of the center, Yin Hongzhang, the chairman of CMBA, PENG Yu, the general secretary of CMBA, Wu Zhaohui and other leaders from six biomedicinal companies attended the meeting.
Vice director of CDE, CFDA Yin Hongzhang said the CFDA had established the biosimilar medicine guideline draft team. Their work was in the survey phase now. This time, they came to CMBA aiming to survey the idea from the companies and to see what CMBA can to. In the meeting, attendees reviewed the development of Chinese biomedicine. They discussed the necessity of biosimilar medicine policy. Attendees agreed that it is necessary to launch the biosimilar policy and standard. They also thought it was reasonable to reduce some approval procedure on the premise of quality guarantee. Also, the standards need to be appropriate.
CMBA submitted the CDE, CFDA "the Research Report of Biosimilar Medicine Policy¡", which was completed through the survey and experts' discussion meeting that was held by CMBA, for their reference. Vice director Yin said that their next work was to go on discussing with enterprises and to enter the academic research phase. Vice director Yin also suggested that CMBA would hold seminar or forum in order to gather the important enterprises and the staffs from CDE, CFDA to discuss the issues.
