Issued by Hunan Province: procurement suspended without conformity assessment

Medical network on October 12, another province officially issued a document, more than 3 enterprises with the same product consistency evaluation, suspended procurement of products without the consistency evaluation ▍ without conformity evaluation, procurement was suspended On October 10, Hunan health and Family Planning Commission issued the notice on ensuring the supply of new drugs and varieties through conformity evaluation of quality and efficacy of generic drugs In terms of price, the notice mentioned that the products deemed to have passed the consistency evaluation are allowed to be directly linked to the network for medical institutions to purchase at the lowest provincial average price (excluding the provinces adopting the market price mode temporarily) in three provinces after passing the consistency evaluation That is to say, the price of Guangdong and other places will not be collected For the varieties without provincial price, the reasonable price can be determined temporarily If the provincial price is less than three, the lowest provincial price can be used temporarily, and the price will be reduced in time within 30 working days after the emergence of new provincial price It is worth noting that the price collection range for price linkage is the price after consistency evaluation In addition, we must focus on the following requirements: 1 If there are more than three manufacturers of the same kind of drugs that have passed the consistency evaluation, the varieties that have not passed the consistency evaluation will no longer be included in the procurement scope of medical institutions 2 The varieties passing the consistency evaluation can apply for the identification of "varieties passing the consistency evaluation" in the provincial medicine centralized procurement platform, and the medical institutions shall give priority to purchasing and using the varieties passing the consistency evaluation According to statistics, up to now, Zhejiang, Hunan, Guangxi, Fujian, Tianjin, Hebei, Jilin, Liaoning, Shaanxi, Gansu and other provinces and cities have also developed civilization and certainty If there are more than three enterprises passing the consistency evaluation for the same variety, the procurement of the varieties failing the consistency evaluation will be suspended Jiangxi Province has taken the lead in suspending the purchase of six products from six enterprises According to the announcement of the State Food and drug administration, the catalogue of Chinese listed drugs and the announcement of listed companies, up to now, 100 drugs have passed the consistency evaluation or deemed to pass the consistency evaluation, involving 80 varieties At the end of this year, only 18 of them must pass the consistency evaluation At present, there are 5 varieties with 3 enterprises, 10 varieties with 2 enterprises, and 65 varieties passing the consistency evaluation temporarily (see the end of the article for the detailed list) There are 5 varieties of three enterprises: 1 Amlodipine besylate tablet (5mg), 2 Tenofovir dipivoxil fumarate tablet (0.3g), 3 Montmorillonite powder (3G), 4 Rosuvastatin calcium tablet (10mg), 5 Cefuroxime dipivoxil tablet (0.25g) 1 Atorvastatin calcium tablets (10mg) 2, atorvastatin calcium tablets (20mg) 3, escitalopram oxalate tablets (10mg) 4, irbesartan tablets (75mg) 5, irbesartan hydrochlorothiazide tablets (150mg irbesartan, 12.5mg hydrochlorothiazide) 6, entecavir dispersible tablets (0.5mg) 7, captopril tablets (25mg) 8 Cefuroxime axetil tablets (0.125g) 9, paclitaxel for injection (albumin binding) (0.1g) 10, amoxicillin capsule (0.25g) in addition to the next consistency evaluation drug in the procurement and use of competition, we also pay attention to the progress of the "289 catalog" product consistency evaluation According to the requirements of the State Council, the consistency evaluation of varieties belonging to the "289 base drug catalogue" shall be completed by the end of 2018 If it is not completed within the time limit, it shall not be registered again The end of the year is coming, but the pass rate of consistency evaluation is so low, I believe most pharmaceutical companies will feel pressure I don't know if there will be a large number of enterprises that have already given up under heavy pressure, but regret to quit the war of consistency evaluation ▍ the two varieties passed the consistency evaluation 1 Amoxicillin capsule 0.25g Today (October 12), Kangenbei released a notice that its holding subsidiary Jinhua Kangenbei received the approval document for supplementary drug application issued by the State Food and Drug Administration on amoxicillin capsule, which passed the consistency evaluation of generic drugs It is a penicillin antibiotic, which is suitable for the eradication of Helicobacter pylori in adults and children with respiratory tract infection, urogenital tract infection, skin and soft tissue infection caused by sensitive bacteria (strains that do not produce β lactamase) and in combination with other drugs As of the date of this announcement, Kangenbei has invested about 4 million yuan in R & D for the consistency evaluation of the drug The specification of Kangenbei passing the consistency evaluation this time is 0.25g It is reported that up to now, only two pharmaceutical companies, UL and conerby, have passed the consistency evaluation of 0.25g amoxicillin capsule According to the requirements of the State Food and drug administration, 0.125g and 0.25g Amoxicillin Capsules must pass the consistency evaluation 289 catalogue by the end of 2018 At present, Amoxicillin Capsules share 241 domestic approvals and 5 Import approvals The pharmaceutical companies with the highest sales volume include UL, Sinopharm, Baker Norton, Baiyunshan, Xiansheng, Harbin pharmaceutical, etc According to the data of minenet, amoxicillin capsule sales in 2017 reached 1.081 billion yuan It is believed that conerby will become the second pharmaceutical enterprise to pass the consistency evaluation after UL this time With the development of national volume procurement and the implementation of provincial consistency evaluation bonus, it will bring a certain impact on the next market pattern 2 Sertraline hydrochloride tablets 50mg In addition, yesterday (October 11), Beijing New Pharmaceutical Co., Ltd also announced that it had recently received the approval document for supplementary application of the chemical "sertraline hydrochloride tablets" approved and issued by the State Food and drug administration The drug passed the consistency evaluation of generic drugs and became the first enterprise to pass the consistency evaluation of sertraline hydrochloride tablets 50mg Sertraline is known to be a selective 5-HT reuptake inhibitor for the treatment of depression related symptoms, including depression with or without a history of anxiety Sertraline is the second largest antidepressant in China, next only to citalopram, and its original research enterprise is Pfizer According to the PDB data, the annual average sales of sertraline in China's sample hospitals during 2012-2017 increased by 10.62%, and the growth rate in China's market remained at a high level From the perspective of market competition pattern, in the first half of 2018, Pfizer accounted for about 75% of the share, ranking first; Beijing new pharmaceutical industry accounted for about 16%, ranking second Up to now, Jingxin Pharmaceutical Co., Ltd is the sole enterprise that has passed the consistency evaluation of this product In the future, the competitive advantage is obvious in the drug centralized purchase, especially in the national volume purchase, and the import substitution is expected to accelerate Attachment: summary of 100 drugs passing the conformity assessment (as of October 12)