clinical safety monitoring project started after the list of traditional chinese injections
’the lesson of houttuynia cordata injection event’ takes more awareness of the importance of evaluation of listed traditional chinese medicine in the industry. a prominent highlight of bio-medicine aspect in ‘twelve-five ‘period is to promote technology of chinese medicine, upgrading its technology content and sales revenue. the study will have 6 traditional chinese medicine enterprises and 31 scientific researching clinical units to be involved, it is the demand of traditional chinese medicine enterprises to seek survival and development, and is also good opportunity for enterprises to turn passive attitude to active
technology major special ‘key technology research’ after list of traditional chinese medicine----clinical safety monitoring of traditional chinese injection was held in beijing, the meeting was mainly held by clinical foundation medical institute of traditional chinese medicine from china academy of chinese medical sciences, and clinical pharmacology branch of traditional chinese medicine from china association of chinese medicine, and was assisted by beijing temple hospital affiliated by capital medical university, what wang yongyan(academician from chinese academy of science) said caused a big concern for many participating traditional chinese medicine injection manufacturing enterprises and hospitals.
due to there are many limit factors in clinical research process of traditional chinese medicine before listing, coupled with chinese medicine as compound preparations itself, makes there are not sufficient content for traditional chinese medicine with its effectiveness, security and medicine economics evaluation; there also lack of research for its effectiveness, security, economic feature and long-term using effect, new adaptation symptoms, and many factors in clinical practice. in addition, it is also difficult to observe before the listing of traditional chinese medicine for some low incidence of side effects and some long time delayed adverse reactions.
deputy commissioner of ‘state food and drug administration’ ren dequan pointed out that ‘most abroad new medicines would be soon carried out medicine epidemiological research after the listing, it can replenish and modify medicine introduction and description list once they get clinical data; while many medicine description will mark ' it is not clear ' words in adverse drug reaction column, they lack of research data systems. as we know, it is a responsible attitude to do research not only for the health of the public, but also for the development of enterprises themselves after the listing of traditional chinese medicine, thus it is very important for the reevaluation and safety inspection listed after the listing of traditional chinese injections.
according to the introduction, this project is mainly charged by tcm clinical basic research institute of the china academy of traditional chinese medicine, wang yongyan academician ,xie yanming from chinese academy of traditional chinese medicine are the head of the project. xie yanming introduced that the main objective of the study is to learn side effects and influencing factors of adverse events in traditional chinese medicine injection, as well as combination and clinical rational use of medicines of proprietary chinese medicines.
used chinese medicine injection between january 2012 and december 2014 will be the research objects, it is estimated that each chinese medicine injection will be at least observed for 30,000 cases (so that it can find rare side effect reaction), research contents are including using information, merged medication information, of chinese medicine injection, physical-chemical check results, bad event/serious bad event records during the treatment, and make standard concentration with same process for all the hospital information system (his), and finally to form a massive database.
it is worth mentioning that currently there are following researching methods for the reevaluation methods of listed traditional chinese medicines: literature review-pharmacology research-clinical experience, systems evaluation, registration research, retrospective survey research, and so on. we seldom see the evaluation of chinese medicines by using hospital information system data, therefore have to say this is an innovative move.
industry development opportunity
deputy director of china biological technology development center of ministry of science and technology, xiao shiying said at the meeting, there are 37 studies on traditional chinese medicine injection research on major projects of ‘major new medicine innovation’ from ministry of science and technology during the ‘eleven-five’ and ‘twelve-five’ period, supported with the funding of about 120 million yuan. it should be said that we take serious attitude on the safety evaluation of injections from traditional chinese medicine. among the 37 topics, there are18 items are about research and development of new medicine (10 single--to a certain extent, this reflects the government's support direction, 4-component, 4 compounds), 12 big types of reconstruction technology, including reevaluation after listing (9 compounds), 7 studies on safety evaluation of injections from traditional chinese medicine. xiao shiying also revealed that there will have continuous funding on safety evaluation after listing of traditional chinese medicine injections during ‘twelve-five’ period.
information from xiao shiying was excited by some production enterprises for injections of traditional chinese medicine. as we all know, due to safety issues, state food and drug administration has suspended the review of injections from traditional chinese medicine, and started to do reevaluation for listed species in 2009. a head of production enterprises from jiangxi province on traditional chinese medicine injections said, ‘year 2005 and year 2006 is the most difficult times for the development of injections from traditional chinese medicine industry, there had no company can make a strong voice, because we lack science and adventurous clinical data to prove the safety and effectiveness of injections. nowadays, more and more enterprises ask to join the ranks of clinical safety evaluation after medicine listing, i believe this is the trend. ”
vice president of chiatai qingchunbao pharmaceutical co.,ltd，xu zhengyu takes agreement on this point of view, in his opinion, the launch of clinical safety monitoring after the listing of chinese medicine is to reveal incidence rate and causes of chinese medicine injection to the whole industry by terms of top layer of design, strict demonstration, and scientific data, which can further guide clinical medication, clinical achievements upgrades products quality standard, promote industry develop with virtuous circle.
at the meeting, six pharmaceutical enterprises like chiatai qingchunbao pharmaceutical co.,ltd, ya’an 39, mu danjiang youbo signed a strategic cooperation framework agreement with clinical leading units on shenmai injection and blood transfusion injection and erigeron breviscapus injection, ixeris sonchifolia hance injection, shenfu injection and xi yanping injection, and started safety monitoring after listing of medicine.
experts believe that traditional chinese medicine injections industry had improved the concentration; expensed single scale after fittest, initiative to improve the quality of chinese medicine injection research institutes and production enterprises is greatly improved. ‘of course, it is difficult to carry out the work, it need injections from traditional chinese medicine production enterprises increase investment, clinical research institutions should also make strict quality control, third-party evaluation of institutions should make objective and impartial evaluation for injections from traditional chinese medicine. "xie yanming added.