On April 28, the CFDA website released the third and fourth batch of generic versions of the drug, covering a total of 32 species. 

 

What is the progress of the enterprise's consistent evaluation of generic drug? This article analyzes the bioequivalence test of the product in 2017 with more than 30 products. 

 

The number of clinical trials registered in 2016 is 770, the highest in three years, according to data released by the CDE clinical trial registration and information platform. In the first four months of 2017 (as of April 25, 2017), the number of clinical trials registered 248, roughly the same as in previous years, according to saldar data V3.2. However, the CFDA approved 4,573 acceptance Numbers in 2015, and approved 3666 clinical trials in 2016, and the number of these received in batches was not much later. 

 

Figure 1. Clinical trial registration number 1, 2014 

 

(source: saldar data V3.2) 

 

In terms of bioequivalence (BE) trials, 210 trials were conducted in 2016, twice as many as in 2015. The number of registrations for the first four months of 2017 is 104, surpassing all of 2015. As a result, the competition for clinical trials begins with a backlog of clinical applications. 

 

Of the 104 bioequivalence trials conducted in 2017, 45 were filed. That this means that the records of the implementation, then declare with previous backlog queue declarant stood for a time the starting line at the same time, given the backlog queue before declaration according to consistency evaluation requirements to complete the project, not to declare the production competition at a disadvantage. 

 

Figure 2. The biological equivalent trial registry is now in 2014 

 

(source: saldar data V3.2) 

 

Most are not started and are cautious 

 

Of the 11 products with more than 30 companies, eight are not 

 

Salty reach data V3.2 by understanding the record reference preparations formed more than 30 products 2017 bioequivalence test carried out to analyze the consistency evaluation of progress. 

 

Amoxicillin capsule 

 

The amoxicin capsule is a product of the largest number of companies in the market, with more than 50 companies filing for the record. In 2017 finally has 3 companies to carry out the bioequivalence test, respectively is guilin pharmaceutical co., LTD., nolato, group of novartis pharmaceutical (shijiazhuang) co., LTD and zhuhai federal pharmaceutical co., LTD. Zhongshan branch. All three have been filed through BE filing and are now being recruited. 

 

Omeprazole capsule 

 

As must be completed by the end of 2018, 289 varieties of consistency evaluation, omeprazole enteric capsules has nearly 50 companies to put on record, but no enterprises to carry out the bioequivalence test. 

 

Metformin hydrochloride 

 

Metformin hydrochloride is also one of 289 varieties, and nearly 50 companies have filed for the record. A bioequivalence trial has been carried out for the 2016 stone pharmaceutical group oyi pharmaceutical co., which has been completed. In 2017, Beijing sihuan pharmaceutical co., LTD., is currently in the process of recruiting through BE filing. 

 

Reitiniin capsule 

 

A total of 48 companies have been filed by the company, which is also one of 289 species, and has not yet been tested for bioequivalence. 

 

Simvastatin tablet and tolazole tablet 

 

Simvastatin tablets and metronidazole tablets varieties list in 289, has nearly 40 companies to put on record, didn't enterprise bioequivalence tests after 2015. 

 

Benzene sulfonate chloride tablet 

 

More than 30 companies have put on record benzene sulfonate chloride. In October 2015, the Beijing tianheng drug research institute was engaged in an experiment in the bioequivalence of benzene sulfonate, which is now "finished". In 2016, changchun haiyue pharmaceutical co., LTD., Yangtze river pharmaceutical group Shanghai heini pharmaceutical co., LTD. And xian ge LanXinTong pharmaceutical co., LTD., three bioequivalence trial, including the Yangtze river pharmaceutical group Shanghai heini pharmaceutical co., LTD., is to BE put on record. In 2017, only one family of jiangsu Yellow River pharmaceutical co., LTD. Has been set up to carry out biological equivalent tests. The trials that have been conducted since the end of 2016 have not been more than the recruitment stage. 

 

Cespora capsule, cefampicin capsule, azithromycin tablet and norofloxacin capsule 

 

289 varieties list of cephalosporins capsule, ammonia benzyl cephalosporin capsules, azithromycin and norfloxacin capsules, has more than 30 enterprises for the record, no enterprise to carry out the bioequivalence trial. 

 

From shown in table 1, amoxicillin capsule, metformin hydrochloride and benzene sulfonic acid amlodipine piece test conducted by the hospital, Beijing ditan hospital affiliated to the capital university of medical sciences, and the Shanghai xuhui district central hospital with two items first, including the Shanghai xuhui district central hospital at the same time receive a product of different enterprise project. 

 

Table 1 amoxicillin capsule, hydrochloric acid metformin and benzene sulfonate chloride tablet 

 

(source: saldar data V3.2) 

 

Small knot 

 

Reference preparations for the record companies a total of 11 more than 30 products, only three products after 2015 enterprises to carry out the bioequivalence test, did not carry out eight products catalogue list in 289. As a result, the current consistency evaluation of 289 species is not yet in the clinical stage. 

 

Many of the projects approved in 2015 and 2016 are generic versions of tech companies. After the MAH system, the technology companies in the pilot cities can start their own projects on their own, and most projects eventually work with production companies. The number of clinical projects has been small, and the downstream companies have been cautious when the cost of clinical trials has been increased. Eventually, the projects that can be launched will be under the name of the more highly creditworthy tech companies. 

 

The corresponding clinical organization of the project 

 

The main focus is on the north, upper, river and ji, and the individual organizations are undertaking more projects 

 

V3.2 discovered 2016 years later, the salty of data, through BE put on record for bioequivalence of clinical trial registration number, a total of 70, the largest number of qilu pharmaceutical co., LTD. Products, a total of three, respectively olanzapine mouth slides, risperidone collapse pills and hydrochloric acid than naphthalene Finn. 

 

70 BE filing products mainly in 38 clinical institutions to carry out the test, the first hospital of jilin university is one of the most popular hospital, a total of seven manufacturers in its bioequivalence test. The hospital of changchun university of traditional Chinese medicine is the second most important hospital in the world. Shanghai xuhui district center hospital, wuxi people's hospital and central south university of hunan were tied for third place. 

 

Further analysis found that since 2016, the first hospital of jilin university of bioequivalence trial registration number 48, 13, changchun university of Chinese medicine affiliated hospital of Shanghai xuhui district central hospital, seven, six in wuxi city people's hospital, central south university xiangya hospital three eight. 

 

Small knot 

 

From clinical institutions, to undertake clinical institutions are mainly distributed in Beijing, Shanghai, jiangsu, jilin, generic drug approval number more undertake clinical institutions are less in guangdong. The number of projects undertaken by individual clinical institutions is high. 

 

Table 2:70 clinical institutions that are corresponding to the "BE"