These 33 drugs do not pass the consistency evaluation!

At present, a variety through the consistency evaluation of the cost of millions of less, more than tens of millions.
of course, the cost of not approving the return to the furnace is even higher.
According 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 "non-approved consistency evaluations", 3 varieties had a high probability of non-approval, and the remaining 24 drugs were finalized for clinical approval for enterprise-declared consistency evaluation.
6 drugs explicitly do not approve consistency evaluation From the public data, there are currently 6 drugs explicitly do not approve the consistency evaluation, involving 4 domestic pharmaceutical companies, namely Guangzhou Baiyunshan, China Pharmaceutical Group Guangdong Global Pharmaceuticals, Jilin Yinglian Bio and Haizheng Pharmaceuticals.
1, Guangzhou Baiyunshan 3 varieties but rated 6 varieties, Guangzhou Baiyunshan covered 3, before the official also announced the reasons for not passing the consistency evaluation.
cephalosporine capsules and cephalosporatin capsules According to previously disclosed information, Guangzhou Baiyunshan cephalosporine capsules and cephalosporadine capsules due to "apply for exemption from THE BE test was rejected", the reasons for the failure of the acetaminophen tablets through the consistency evaluation is temporarily unknown.
according to 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 approval.
and the variety has now been evaluated by 4 enterprises, and 10 enterprises have submitted additional applications for consistency evaluation.
the same process as the cephalosporatin capsule, and baiyunshan has now completed the BE test and resubmitted the supplementary application.
the reasons for the failure of the acetaminophe to the film, 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 shall, in accordance with the policies and related technical requirements of the State Drug Administration on drug review and approval, arrange relevant research and development work, and propose to resubmit the application for consistency evaluation after supplementation and improvement."
Insight database, the latest declaration information for the product in Baiyunshan has not been found at CDE.
at present, the variety has not yet passed the consistency evaluation.
is a sputum regulator that can affect the secretion of the bronchial glands and reduce the viscosity of the sputum.
is used to treat chronic bronchitis, bronchial asthma and other diseases caused by sputum viscous, coughing sputum difficulties and other symptoms.
public 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 Selling Leading, accounting for 48% and 39% respectively.
from sales can be guessed, the variety of sales revenue does not cover the cost of consistency evaluation, the data also show that the variety of the number of enterprises held 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 for the record of 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 silence, or even eventually disappear silently.
2, Haizheng Tachemos capsule saxom capsule did not have a consistency evaluation, previously cDE gave professional reasons to state that "the product in 2015 after the original european registered declaration country has not re-registered, can not provide information on clinical use and adverse reactions in recent years the original listed country clinical use and adverse reactions, and this product in the domestic narrow treatment index Drugs, China's BE trial of such drugs has related technical requirements, foreign BE test data show that Cmax 90% confidence interval of 105.563%-117.928%, not in China's requirements for narrow treatment window drugs 90.00%-111.11%.
tha crosmos capsules for narrow treatment index drugs, the development of difficult, there is no domestic enterprises to declare the consistency of this product evaluation.
" Tacmos is a powerful immunosuppressant that prevents organ rejection after liver, kidney, and heart transplantation, and treats liver or kidney transplants with other immunosuppressive drugs that cannot be controlled by transplantation. Developed by Fujisawa (now Astre) in Japan,
, it was listed in Japan in 1993 and imported domestically in 2001.
2008, Haizheng's first domestic generic listing.
public data show that the oxmers is a heavy-duty drug, with global sales peaking at $2.2 billion, and four domestic generic stakes have been approved in China in addition to imports of original research, but none of them have been evaluated.
3, acetaminophen tablets, Luo solofen sodium tablets, Guangdong Global Pharmaceuticals of Guangdong Global Pharmaceuticals, Jilin Yinglian's Lonsolofen sodium tablets, the reasons for non-approval are not known, but in the BE trial did not find the enterprise's trial of the variety.
4, Zhengda Tianqing 2 injection sending injection consistency evaluation specific technical requirements documents in May 2020, so far through the consistency evaluation of the variety of injections very few, but according to insight database statistics, as of June 16, 752 injection consistency evaluation acceptance number submitted supplementary applications, involving 172 enterprises, but no review conclusions.
June 16, NMPA official website issued a batch of product approval comments notice pending information shows that the consistency evaluation supplement application submitted by the 2 injection varieties of Zhengda Qing did not send approval documents, but sent drug approval advice, which means that the two varieties are highly likely not to approve the consistency evaluation, 2 varieties are sodium pyridoxea injection and hydrochloric acid 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 a listing application for the species in accordance with the newly registered classification 4, and it appears that the consistency evaluation of the species will be done sooner or later.
hydrochloric acid Palonosian injection is a classification of the old classification 3.1 declaration, was approved for listing in 2006;
5, Huazhong Pharmaceutical Spore perforcine capsule June 19, the State Drug Administration published the drug approval notice pending information, China Central Pharmaceutical Industry submitted the first spore emanation capsule consistency evaluation supplement application did not receive the approval documents, but the review opinion, meaning that the variety is very likely not to pass the consistency evaluation. according to the
Insight database, Huazhong Pharmaceuticals launched a bioequivalence trial of the species in March 2019 and submitted a supplementary application for the consistency evaluation of the species in November of the same year.
the variety is the country's second batch of collected varieties, there are currently 9 enterprises through the consistency evaluation, in addition to 270 symbols have not made progress.
24 species approved clinically according to the Insight database, as of mid-June 2020, there were 42 consistency evaluation acceptance numbers that concluded that the final review concluded that they were approved clinically, involving 24 varieties of different enterprises, of which the most approved clinical varieties were renititin capsules, for a total of 13 enterprises.
13 companies approved for clinical renitine, it is not a stranger to the presence of a cancer-causing nitroamine impurity, N-nitrometformamine (NDMA), which was all off the FDA shelves.
also took steps in the country, in December 2019, the Pharmacopeia Commission issued a revised revised revision of the drug standards for renitin-related drugs, and the Renititin standard proposed to increase NDMA impurity control.
Insight database, there are currently 24 acceptance numbers (involving 20 companies) for renittinine to declare supplementary applications for consistency evaluation, of which 14 are approved for clinical purposes;
renitinist is the most clinically approved variety for consistency evaluation, and it is speculated that the reason for the need to increase NDMA impurity control after the revision of the drug standard.
: All consistent evaluation sischers approved for clinical medicines (statistics as of June 2020)