Medical network - on April 12, April 5, the state food and drug supervision and administration bureau website issued a "generic quality consistency and efficacy evaluation varieties classification guidance" (hereinafter referred to as "opinions"), to the next step to carry out the generic consistency evaluation classification, the varieties of the original import listed species, the original enterprise within the territory of China listed varieties, domestic and imported generic varieties of generic variety, dosage forms, specifications, change is to base the generic varieties, domestic special varieties for details. 

 

Relevant data show that as of March 14, received the record number of 4825 pieces, for the record number is 833. Among them, the first evaluation of 289 varieties, the record number of varieties to 2623, involving 234 varieties. From the overall situation of the provinces for the record, is currently the largest number of jiangsu province, in 589, followed by guangdong 423 407 407, shandong, zhejiang, Shanghai, 325, Beijing 315, 232, hebei 208 of them in sichuan province. 

 

Reporter also learned that at present with the maximum number of varieties for the record manufacturer is amoxicillin capsules, 96. In addition, no record in the 289 varieties of species for 55, phenolphthalein tablet (52), diphenyl double ester (54), atropine sulfate tablets (58), ibuprofen capsules (86), albendazole capsule (90), metronidazole capsules (120), cefepime semustine capsule (176), la set (232), vitamin A acid pills (257), morphine hydrochloride zyban (237), compound ZuoHuanNuo progesterone tablets (247), for indications capsule (220), etc. 

 

Is divided into six categories 

 

"Opinions" clearly pointed out that, in view of the original import listed varieties, don't need to carry out the consistency evaluation, by the state food and drug supervision and administration of management audit to determine after the release, can choose for the reference preparation. Against the original enterprise within the territory of China listed species, the original enterprise within the territory of China listed varieties, production by the state food and drug supervision and administration of management audit to determine after the release, can choose for the reference preparation. 

 

Before to import generic varieties, listed in accordance with the principle of in line with the original drug quality and curative effect of reporting and review, submit an application by the enterprise, the administration of state food and drug supervision and administration of the administrative matters to accept the service and complaint reporting center to receive information, total bureau of national food and drug supervision and administration of drug approval center audit and put forward opinions, submitted to the state food and drug administration bureau released; Pre-ipo fail to in line with the original drug quality and curative effect of report and review of principle, to carry out consistency evaluation in accordance with relevant regulations. 

 

For domestic imitation varieties, the pre-ipo in line with the original drug quality and curative effect of report and review of principle, in accordance with the prescribed in paragraph 1 of article 3 of the above program execution; According to in line with the original drug quality and curative effect of report and review of principle, in accordance with the relevant regulations, to carry out the consistency evaluation. 

 

Change specifications, base of generic variety, dosage forms, change is to be issued in accordance with the state administration of food and drug supervision and administration of the quality of generic drugs and drug efficacy evaluation of consistency change specifications (oral solid preparation) evaluation generally consider the quality of generic drugs and curative effect evaluation of consistency in the change of dosage form drug (oral solid preparation) evaluation generally consider the quality of generic drugs and curative effect evaluation of consistency in the change of base medicines evaluation generally considered "guiding principle to carry out the consistency evaluation. 

 

Domestic unique varieties, by the enterprises to choose to carry out clinical trials to prove its effectiveness, safety and refer to the generic chemical medicine oral solid preparation quality and curative effect evaluation declaration data consistency requirements (try out) ", the filing of the subsequent audit after inspect through consistency evaluation; Companies did not choose to carry out clinical trials, the state food and drug supervision and administration bureau announced its lack of effectiveness data, is not recommended. 

 

The evaluation work for long 

 

"Opinions" pointed out that "if in the quality of generic drugs and curative effect evaluation of consistency, in case of major technical problems and disputes, relevant departments will organize a committee of experts." This also means that the work in the process of advancing, there is a more uncertain factors, need the government, enterprises, institutions together hand in hand, eventually improve the overall level of the pharmaceutical industry in our country, to ensure drug safety and effectiveness, and the aim of pharmaceutical industry upgrading and structural adjustment. 

 

It is reported that the United States in 1971, officially launched the bioequivalence evaluation, after 10 years, eliminated 6000 drugs; Britain drug laws in 1975 to 1975 before the public, and not subject to any independent drug safety and effectiveness of the data review, involving 36000 drugs; Japan launched the "drug quality evaluation project again" time late, has a total of 1997 completed about 730 varieties. 

 

In fact, on the basis of summarizing foreign experience, generic quality and curative effect evaluation to promote consistency in our country the accelerating speed. At the beginning of 2017, generic quality consistency evaluation of the effect of organization office held three reference formulation selection meeting, review by the 46 species gauge (82), the first batch of registered 289 varieties have 36 gauge (51), gradually will also have more recommended reference preparations. 

 

In addition, at present our country has already opened consistency evaluation column, timely release related policies and regulations, news, reference information, evaluation information, business guidance and work progress. Set up foreign database links, the FDA oral solid preparation dissolution methods database, Japan evaluation data collection, in vitro dissolution of drug evaluation center drug test information database. Until now, the administration and inspection institute consistency evaluation column published work documents, guiding principles and varieties of evaluation information, reference information content such as more than 100. 

 

Authorities revealed that the relevant departments will continue to push forward reference preparations for the record, the improvement of the technical guidelines, specifications, check) filings inspection template for business. Organization expert review to determine the reference preparations, gradually establish the generic reference preparation directory. According to the generic consistency evaluation of the business progress, timely in the system to carry out the policy and technical training. At present, 289 varieties of review work and review guide is assigned to the 31 provinces YaoJianSuo, each variety has exclusive technical standard and the re-inspection agency. Each bear the inspection institution for evaluation of the consistency of the manufacturing enterprise to submit the data to carry on the review, according to the results of the review to build our country oral solid preparation dissolution curve database.