Medical network - March 1 TCM injections again double test of safety and effectiveness.
▍ TCM injections by "test"
27, the director of the state administration of food and drug supervision and administration of jingquan said publicly in the scio meeting, to start the drug safety, effectiveness and evaluation of traditional Chinese medicine injection and accelerate the process checking, etc.
At this point, from the birth of conservative controversy at the beginning of the innovation varieties of traditional Chinese medicine injections are required to open again "test".
Once again, and this has been in recent years the state explicitly release signals to reassess the once innovation varieties, based on considerations of safety and effectiveness, both, also is the main opponents question its roots.
Due to the frequent problems of adverse drug reactions, the CFDA was released in 2009 TCM injections safety evaluation of quality control points again, and the basic technical requirements for TCM injections safety evaluation again, fully launched China's traditional Chinese medicine (TCM) injection safety evaluation work again.
Then, under the background of national drug consistency evaluation start, in October 2015, the state food and drug administration issued a division table about the implement of drugs, medical devices, the four departments are related to their responsibilities within the scope of the task in the file, in addition to the part of the project, the country also list the start time and completion time, the task list, including traditional Chinese medicine injection to evaluation.
▍ varieties of storage charges
In fact, after a longer time, market and civil dispute regarding large varieties of traditional Chinese medicine had arrived at many times, the decision makers on varieties of storage fee dispute also never cease.
During the "two sessions" in 2014, the National People's Congress, margin pharmaceutical chairman xiao kang has publicly put forward a suggestion, based on safety consideration, should be led by the CFDA, formed by the medical and pharmaceutical authoritative expert members of the third party assessment committee, responsible for TCM injections and evaluation, organization or the designated professional institute evaluation assessment work.
He also revealed that there are some traditional Chinese medicine injection production enterprise actively carry out the related research work, but because of the lack of corresponding professional and authoritative appraisal institution to evaluate the results of the study, and then make complete clinical safety evaluation work of enterprise.
What market panic and calendar year with the adverse drug reactions monitoring report issued by the state.
In July 2016, the national adverse drug reaction monitoring center released a set of monitoring data show that: according to the statistics of pharmaceutical dosage forms, 2015 report adverse drug reactions/events involved in the distribution of pharmaceutical dosage forms, injection, oral preparations accounted for 34.7%, other 61.3% preparations accounted for 4.0%. Injection a 3.5% increase in 2014, the proportion of oral preparation proportion reduced by 1.5%.
In 2015 the national adverse drug reaction monitoring network was received traditional Chinese medicine injections reported 127000 cases, including serious report 9798 cases (7.7%). 2015 Chinese medicine adverse reactions/events report, the injection ratio is 51.3%, 2.1% less than in 2014.
Among them, the TCM injections severe damage report mainly involves systemic damage, respiratory system, skin and its accessories damage, etc., including allergic reaction, anaphylactic shock, chills, fever, difficulty breathing, chest tightness, heart palpitations, itching, rash, nausea, vomiting, and in monitoring the situation.
TCM injections report 2015 ranking among the number of categories is a blood thinner, boosting agent, begin to understand, clear heat, nourish the agent, expectorant, accounted for 97.0% of Chinese medicine injection report. Report the number of the top five medicines are: qing ling injection, and mai injection, blood injections, ShuangHuangLian injection, shu ning injection on blood.
In addition, the TCM injections overall report 2015 top 20 drugs (87.6% for the traditional Chinese medicine injection report) analyses the effect of drug combination, its overall report involves the drug combination was 43.4%, 56.5% report involving the drug combination serious - visible start injection quality consistency and curative effect evaluation, its necessity.
At present, there are 303 enterprises of our country has 134 varieties of traditional Chinese medicine injection dosage forms 1255 different specifications of the production approval, which commonly used in more than 50 varieties, 2012 TCM injections market scale in about 32 billion yuan.
And this country sfda in public key and then ask the TCM injections and evaluation, and emphasizing on drug safety conference, there is no doubt that clearly convey a message, a risk that regulators for varieties of considerations will be tighter and tighter, lots of problems of varieties or will suffer the most severe knockout round.
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