These 33 drugs do not pass the consistency evaluation!

TextMicroyangat present, a variety through the consistency evaluation of the cost of millions of less, more than tens of millionsOf course, the possibility of not approving the return to the furnace is even higherAccording to the Insight database, there were 33 drugs that did not pass the consistency evaluation as of June 2020, of which 6 varieties were explicitly defined as "non-approval consistency evaluation", 3 varieties had a high probability of non-approval, and the remaining 24 drugs were finalized for clinical approval for enterprise-declared consistency evaluationfrom the public data, there are currently 6 drugs explicitly do not approve the consistency evaluation, involving 4 domestic pharmaceutical companies, namely, Guangzhou Baiyunshan, China National Pharmaceutical Group Guangdong Global Pharmaceuticals, Jilin Yinglian Bio and Haizheng PharmaceuticalsOf the six varieties, Guangzhou Baiyunshan covered three, after officials also announced the reasons for not passing the consistency evaluationaccording to previously disclosed information, Guangzhou Baiyunshan cephalosporine capsules and cephalosporadin capsules due to "application for exemption from THE BE test was rejected", the reasons for the failure of the acetaminophen tablets through consistency evaluation is temporarily unknownaccording to the Insight database, Baiyunshan conducted a bioequivalence trial of cephalosporine capsules in September 2018 and resubmitted a supplementary application for consistency evaluation of the species in July 2019, which is currently under review and approvalThe variety has now been evaluated by 4 enterprises, and 10 enterprises have submitted additional applications for consistency evaluationcephalosporatin capsules are the same process, and Baiyunshan has now completed the BE test and resubmitted the supplementary applicationfor the reasons for the failure of the acetaminophe tablets, Baiyunshan Pharmaceutical General Factory has issued a notice that "in accordance with the consistency evaluation review and approval regulatory requirements, after research, Baiyunshan Pharmaceuticals believes that the project BE research volume is small and product storage conditions and reference preparations are different, so the initiative to apply for withdrawal." Baiyunshan Pharmaceutical General Factory intends to arrange relevant research and development work in accordance with the policy and related technical requirements of the State Drug Administration on drug review and approval, and to resubmit the consistency evaluation application after supplementation and improvementInsight database, the latest declaration information for the product in Baiyunshan has not been found at CDEAt present, the variety has not yet passed the consistency evaluationis a sputum regulator that can affect the secretion of the bronchial glands and reduce the viscosity of the sputumFor the treatment of chronic bronchitis, bronchial asthma and other diseases caused by sputum viscous, coughing sputum difficulties and other symptomsPublic data show that in 2017, the sales of public hospitals in key cities were 15.85 million yuan, with Beijing Chengji Pharmaceuticals and Baiyunshan Pharmaceutical Sefactory accounting for 48% and 39% respectively from sales can be guessed, the variety sales revenue does not cover the cost of consistency evaluation, the data also show that the variety of the number of enterprises holding most of the choice of silence Insight database shows that only Linyishan Pine Pharmaceuticals is currently carrying out BE, Baiyunshan Tangyin Dongtai Pharmaceuticals and Guangdong South China Pharmaceuticals to file reference preparations, and another 109 documents have not made progress at present, large varieties must do consistency evaluation, for small varieties of most enterprises may choose to silence, or even eventually disappear silently Haizheng's Tekmos capsule did not have a consistency evaluation, previously given by CDE professional reasons pointed out that "the product after 2015 in Europe's original registered declaration countries have not been re-registered, can not provide information on clinical use and adverse reactions in recent years in the original listed countries, and this product is a narrow treatment index drug in China, China on such The BE test of the drug has related technical requirements, and the foreign BE test data show that Cmax's 90% confidence interval is 105.563%-117.928%, which does not fall within the 90.00%-111.11% range of China's requirements for narrow treatment window drugs Heacmos capsules for narrow treatment index drugs, the development of difficult, there is no domestic enterprises to declare the consistency of this product evaluation takermos is a powerful immunosuppressant that prevents organ rejection after liver, kidney and heart transplants, and treats liver or kidney transplants with other immunosuppressive drugs that cannot be controlled by transplantrejection Developed by Fujisawa Corporation of Japan (now Astellas), the original drug was listed in Japan in 1993 and imported domestically in 2001 In 2008, Haizheng was the first domestic imitation to go on the market public data show that heacmos is a heavy-duty drug, with global sales peaking at $2.2 billion, and four domestic generic drugs have been approved in china in addition to imports, but they have not been evaluated National Pharmaceutical Group Guangdong Global Pharmaceuticals acetaminophen tablets, Jilin Yinglian's Lonsolofen sodium tablets, the reason for the non-approval is not known, but in the BE trial did not find the enterprise's test of the variety specific technical requirements for injection consistency evaluation were officially launched in May 2020, and so far few injections have been approved through consistency evaluation, but according to insight database statistics, as of June 16, 752 injection consistency evaluation acceptance numbers have been submitted for supplementary applications, involving 172 enterprises, but no review conclusions have been reached June 16, NMPA official website published a batch of product approval comments notice pending information shows that the 2 injection stakes of the two injection stakes submitted by the consistency evaluation supplement application did not send approval documents, but sent drug approval advice, which means that the two varieties are most likely not to approve the consistency evaluation, 2 varieties are sodium pyreth yepso injection and hydrochloride Paronosinjection injection Zhengda Tianqing citric acid di sodium injection was approved in June 2019 as the first imitation domestic, but the registered classification is the old category 6, requiring a consistency evaluation, but did not find that it has carried out be tests At present, Collum Pharmaceuticals has submitted the listing application for the variety in accordance with the newly registered classification 4 category, it seems that the consistency evaluation of the variety is to be done sooner or later hydrochloric acid Palonosqiong injection is a classification of the old registration 3.1 declaration, was approved for listing in 2006; On June 19, , in the information to be received in the notice of the drug approval opinion published by the State Drug Administration, the supplementary application for the consistency evaluation of cephalosporine capsules submitted by China Central Pharmaceutical Co., China Pharmaceutical co., China Pharmaceuticalco did not receive the approval documents, but the review opinion, which means that the variety is most likely not approved for consistency evaluation Insight database shows that Huazhong Pharmaceuticals launched a bioequivalence trial of the species in March 2019 and submitted a supplementary application for consistency evaluation of the species in November of the same year the variety is the country's second batch of collection varieties, there are currently 9 enterprises through the consistency evaluation, in addition to 270 symbols have not made progress According to the Insight database, as of mid-June 2020, there were 42 consistency evaluation acceptance numbers that concluded that the final review was approved clinically, involving 24 varieties of different enterprises, of which the most clinically approved varieties were Renititin capsules, for a total of 13 enterprises reinitetin is no stranger to drugs that have been removed from the FDA in the past after the discovery of a cancer-causing nitrosamine impurity, N-nitrometamine (NDMA) also took steps domestically, and in December 2019, the Pharmacopeia Commission issued a revised revised revision of the drug standards for renitin-related drugs, which proposed to increase NDMA impurity control according to the Insight database, there are currently 24 acceptance numbers (involving 20 companies) for renittinine supplementary applications, of which 14 have been approved for clinical purposes, and only 2 companies have passed the consistency evaluation, namely, the stony pharmaceutical group reinitibdine capsule steamed acid and Ruiyang Pharmaceuticals' renitinodine tablets Renititin is currently the most approved clinical variety of consistency evaluation, guessing that because of the need to increase NDMA impurity control after the revision of drug standards attached: All consistent evaluation approved clinical drugs (statistics as of June 2020) .