What is the recommended consistency evaluation research and analysis system?

Analysis of consistency evaluation: 95 varieties were over-evaluated, and 17 varieties were over-evaluated for the first time.

Source: Yaozhi. Com/ Ling Yan

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On June+10, 5438, CDE added 88 acceptance numbers (54 varieties and 53 enterprises).

65438+1October 150 approvals (including deemed approval) involved 95 varieties.

According to the consistency evaluation and analysis system of drug information data enterprise edition, 88 consistency evaluation acceptance numbers were added in June 2022. There are 150 approvals (57 of which are considered as passed). (At the end of the article, a detailed list of consistency evaluation of 1 month declaration and over-evaluation is attached. )

Figure120265438+0-Declaration/Adoption Trend in June 2022

Data sources: Data from Drug Intelligence and Drug Information Consultation and Arrangement.

Overcommitment details

1 month, a total of 150 batches passed/were deemed to have passed the conformity evaluation, involving 95 varieties of 97 enterprises, of which 17 varieties were evaluated for the first time.

In terms of enterprises that have passed the consistency evaluation, Nanyao Zheng Da Tianqing, Sinopharm Group Zhijun (Shenyao) Pharmaceutical, Ruiyang Pharmaceutical and Chen Xin Pharmaceutical all passed the consistency evaluation on June 5438+ 10, and tied for the first place. See the figure below for details.

Fig. 2 Number of varieties passed by enterprises in June 2022, 5438+ 10 TOP 10

Data sources: Data from Drug Intelligence and Drug Information Consultation and Arrangement.

Nanjing Zheng Da Tianqing Pharmaceutical Co., Ltd. is a Sino-foreign joint venture high-tech enterprise jointly funded by Zheng Da Pharmaceutical, Jiangsu Agricultural Reclamation, Jiangsu Zheng Da Tianqing Pharmaceutical and Lianyungang Jin Kang Investment. The company inherited Zheng Da Tianqing's experience in drug production and quality management for more than 30 years, relied on the powerful R&D platform of postdoctoral research center and new drug R&D center, and ensured the high-level production and quality of products through first-class equipment, advanced technology and strict production quality management, thus winning one of the first batch of 13 "demonstration enterprises of drug quality integrity construction" in China. Up to now, 47 varieties have been evaluated for consistency (including the declaration of newly registered generic drugs) and 28 varieties have been evaluated.

Sinopharm Group Zhijun (Shenzhen) Pharmaceutical Co., Ltd. is located in the export-oriented professional cephalosporin preparation production base and the domestic high-end preparation production base, and has obtained many international high-standard certifications such as powder injection, oral EU double certification and WHO PQ certification. Adhering to the quality management concept of "continuous improvement, lean products", the company has continuously promoted lean management and excellent performance, and created a number of brand-name products with the highest market share, among which Dalixin and Dalifen have become leaders of similar products, and their products have entered the mainstream market of the European Union and gradually established international brands. Up to now, a total of 14 varieties (including the declaration of newly registered generic drugs) have been evaluated, of which 8 varieties have been evaluated.

Ruiyang Pharmaceutical Co., Ltd. (formerly Yimeng Xinhua Pharmaceutical Factory in Shandong Province) is located in Yiyuan County, Zibo City, and is the first powder injection manufacturer in Shandong Province. Ruiyang Pharmaceutical adheres to the business tenet of "Ruiyang Pharmaceuticals, Benefiting from the Four Sides", and adheres to the business strategy of innovation-oriented, quality first, strong internal management, brand building outside, elite cohesion, openness and win-win, "loyalty and trustworthiness, perseverance, hard work, innovation and enterprising", and has grown from a third-line enterprise to one of the top 50 pharmaceutical enterprises in China and one of the pillar enterprises in Yiyuan County. Up to now, 49 varieties of the company have been evaluated for consistency (including the declaration of newly registered generic drugs) and 22 varieties have been evaluated.

Chen Xin Pharmaceutical Co., Ltd. is a national high-tech enterprise, a postdoctoral research mobile station, an enterprise technology center in Shandong Province and an antibiotic engineering technology research center in Shandong Province. Has won the National Development and Reform Commission industrialization support fund, China patent Shandong star enterprise and other honors. The leading product, large infusion, has a total production capacity of more than 600 million bottles (bags)/year, ranking first among domestic single factories. Adhering to the concept of "promoting innovation through innovation, being honest and trustworthy", Chen Xin Pharmaceutical Co., Ltd. takes protecting patients' lives as its own responsibility, and devotes itself to independent research and development and production of drugs with independent intellectual property rights to fill domestic gaps. Up to now, 30 varieties of the company have been evaluated for consistency (including the declaration of newly registered generic drugs), and 10 varieties have been evaluated.

In terms of varieties, five companies have reviewed entecavir tablets in May 438+10, ranking first, three companies have reviewed atosiban acetate injection, ranking second, and two companies have reviewed rivaroxaban tablets and other varieties. See the figure below for details.

Fig. 3 Number of enterprises that passed varieties in June 2022 (5438+ 10) TOP 10

Data sources: Data from Drug Intelligence and Drug Information Consultation and Arrangement.

Entecavir tablets are suitable for the treatment of chronic adult hepatitis B (including patients with compensatory and decompensated liver diseases) with active virus replication, continuous increase of serum alanine aminotransferase or active liver lesions; It is also suitable for the treatment of children aged 2 to 3.

Atosiban acetate injection is suitable for pregnant women with the following conditions to delay imminent premature delivery: ① Regular contractions for at least 30 seconds every time, and ≥ 4 times every 30 minutes; ② Cervical dilatation 1 ~ 3 cm (0 ~ 3 cm for puerpera) and uterine softening/thinning ≥50%- age ≥ 18 years old-24 ~ 33 weeks pregnant; ③ The fetal heart rate is normal. Up to now, seven enterprises have applied for consistency evaluation of atosiban acetate injection (including the application for newly registered generic drugs), and five enterprises have conducted evaluation.

54 varieties were declared, and the injection rate exceeded 60%.

On June 5438+ 10, 2022, CDE added 88 acceptance numbers for conformity evaluation, involving 54 varieties of 53 enterprises, of which injections accounted for more than 60% again.

Fig. 4 Details of dosage forms declared in June 2038+October 20221October.

Data sources: Data from Drug Intelligence and Drug Information Consultation and Arrangement.

In terms of declared varieties, on June 5438+ 10, 2022, piperacillin sodium tazobactam sodium for injection received 8 acceptance numbers, ranking first. Cefotaxime sodium for injection, with 7 acceptance numbers, ranked second. In addition, piperacillin sodium for injection has four acceptance numbers, ranking third. See the figure below for details.

Fig. 5 Number of varieties declared and accepted in June 2022 at 5438+ 10 TOP 10

Data sources: Data from Drug Intelligence and Drug Information Consultation and Arrangement.

Piperacillin sodium tazobactam sodium for injection is suitable for septicemia, complicated cystitis and pyelonephritis caused by Staphylococcus, Escherichia, Citrobacter, Klebsiella, Enterobacter, Providence and Pseudomonas which are sensitive to this product. Up to now, nine enterprises have applied for consistency evaluation, and only Qilu Tianhe Huishi Pharmaceutical and Huabei Pharmaceutical have made evaluations.

Cefotaxime sodium for injection is suitable for pneumonia caused by sensitive bacteria and other lower respiratory tract infections, urinary tract infections, meningitis, septicemia, abdominal infection, pelvic infection, skin and soft tissue infections, reproductive tract infections, bone and joint infections, etc. Cefotaxime can be used as the first choice for the treatment of meningitis in children. Up to now, 13 companies have applied for compliance evaluation, and only two companies, Suzhou Sinochem piperacillin sodium Products Industry and Guangdong Jincheng Jinsu Pharmaceutical, have conducted compliance evaluation.

Piperacillin sodium for injection is suitable for septicemia, upper urinary tract and complicated urinary tract infection, respiratory tract infection, biliary tract infection, abdominal cavity infection, pelvic infection and skin and soft tissue infection caused by sensitive enterobacteriaceae bacteria, Pseudomonas aeruginosa and Acinetobacter. Piperacillin combined with aminoglycosides can also be used for infection in patients with neutropenia and immunodeficiency. So far, three companies have applied for consistency evaluation, and none of them have passed the evaluation.

From the perspective of enterprises, in June 5438+ 10, Lu Kang, Shandong Province, 7 acceptance numbers were accepted, ranking first. Followed by Chengdu Bite and Hainan General Sanyo, all five acceptance numbers accepted the declaration consistency evaluation. See the figure below for details.

Figure 6 Number of applications accepted by enterprises in June 2022, 5438+ 10 TOP 10

Data sources: Data from Drug Intelligence and Drug Information Consultation and Arrangement.

Lu Kang, Shandong Province is committed to the development of ecological medicine, insisting on scientific and technological innovation, marketing innovation and management innovation, and has embarked on a road of development with its own characteristics, gradually becoming a modern large-scale enterprise group with drug manufacturing and drug trade as the mainstay, supplemented by scientific research consultation, technology development and quality monitoring. At present, the company has declared/deemed to declare 28 varieties, including 13 evaluated varieties.

Chengdu Beite Pharmaceutical Co., Ltd. is a high-tech enterprise specializing in pharmaceutical innovation and R&D, producing and selling high-quality drugs. Six production bases and two marketing systems of preparations and raw materials have been established. It integrates R&D, production and sales, covering the whole ecological pharmaceutical industry chain from intermediates, raw materials to preparations. At present, the company has declared/deemed to declare 74 varieties and 38 varieties have been reviewed.

Hainan General Sanyo Pharmaceutical Co., Ltd. was established on 200 1, located at No.8 Lihai Road, xiuying district, Haikou City, Hainan Province. Is a high-tech enterprise integrating pharmaceutical R&D and production. The shareholder of the company is China Pharmaceutical and Health Industry Co., Ltd., which belongs to China General Technology (Group) Holding Co., Ltd. Its products cover antibiotics, drugs for regulating blood lipid, drugs for improving brain function and drugs for digestive system, among which enzyme-resistant compound antibiotics are in the leading position in the industry. At present, the company has declared/deemed to declare 14 varieties, of which 4 varieties have passed the review.

Attached table 1: List of conformity assessment passed (including deemed passed) on June 2022/kloc-0.

Data as of February 8, 2022.

Attached Table 2: List of Conformity Assessment of Declaration in June 5438+ 10, 2022

Data as of February 8, 2022.

Data source: drug intelligence data generic drug conformity evaluation and analysis system.

Editor in Charge: Liuli

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