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| The generic conformance evaluation of 3 varieties in the 289 catalog was abandoned |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-7 14:39:07 Number Browse：618 |
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Medical network August 7 - recently, the reporter from "2017 generic drugs quality consistency evaluation of the effect of high level conference on learned that at present the country has to carry out the evaluation of the directory 289 varieties, the enterprise choose not to give up evaluation of 286 varieties, the variety has embarked on evaluation of the research involves 274, not to carry out the evaluation of 12 varieties. Among them, medroxyprogesterone acetate capsule, diclofenac sodium sustained-release capsules Ⅲ, clindamycin hydrochloride tablets three varieties all choose to give up temporarily.
Drug review of medical equipment examination and approval system reform leading group relevant experts said, with the advancement of generics consistency evaluation, enterprises to give up some varieties more and more decisive, enterprise wait-and-see mood, significant temperature drop of consistency evaluation to evaluate whether name varieties attitude is more and more clear. From the consistency evaluation of the statistical data of various stages, the reference preparation has been fully spread out, and the study of pharmaceutical research has been widely carried out.
In addition, for the abandoned varieties, jiangsu province has already explored some new paths, which can be used for reference for other provinces and cities. Jiangsu province has 445 drug approval Numbers to carry out a consistent evaluation, and 247 varieties have been abandoned, according to the head of the food and drug administration in jiangsu province. In order to solve these abandoned varieties, jiangsu province initiated a public announcement on the platform of the provincial bureau to make use of the system of licensing holders of drugs to make public bidding.
The enterprise has completed the declaration
On August 17, 2016, the state administration of food and drug administration issued a statement announcing that the quality and efficacy of generic drugs should be completed before the end of 2018. As of the end of May 2017, 31 provincial-level bureaus reported a total of 289 catalogues of the total variety of the total varieties, involving 16,287 approval Numbers and 1,649 production enterprises.
From the perspective of the whole country, in addition to the Tibet no 289 category, other provinces have carried out the consistency evaluation work. In henan, Shanghai, shanxi, shandong, jiangsu and other 14 provinces, the number of approval number is over 100, and the proportion that has been evaluated should be higher than 50%. Inner Mongolia, gansu, xinjiang and other three provinces to carry out the evaluation of the approval number only stay in single digits, and evaluate varieties accounted for only 10% of the evaluation should be the following, the overall evaluation of progress is slower.
At the meeting, experts pointed out that while the overall evaluation of generic drug consistency was progressing smoothly, there was still progress imbalance. In particular, because different enterprises have different understanding of the consistency evaluation work, the enthusiasm of carrying out evaluation is different, and the difference of progress is obvious. Some large pharmaceutical enterprises still have serious negative waiting situations. They should evaluate the approval number of more than 30, but the number of evaluation has been reduced, the proportion is less than 10%, and the progress is obviously lagging behind.
According to incomplete statistics, there are 758 enterprises in 1694 enterprises that have a variety of conformity assessment, accounting for 44.7%. There are 936 enterprises that have not had the consistency evaluation, accounting for 55.3%. Shanghai xinyi balance pharmaceutical co., LTD., kaifeng pharmaceutical co., LTD., tianfang pharmaceutical co., LTD., etc., have carried out evaluation approval number of more than 30. Zhejiang jingxin pharmaceutical co., jiangsu yangzijiang pharmaceutical industry has completed the declaration of varieties.
The goal is to be achieved
Promoting the quality and efficacy of generic drugs is the key task of the state administration in 2017. Close a reporter to send report, the state food and drug supervision and administration bureau has officially released eight group of generics consistency evaluation reference preparation directory, a total of 610 product gauge reference preparations, which belong to 289 directory has 224 rules, 289 directory has 386 rules.
At the same time, to standardize and guide the various aspects to carry out the consistency evaluation, national administration organization issued 21 items of all kinds of form a complete set of file, set up the authority of the consistency of the evaluation expert committee, the selected reference preparations such as core issues in the review. The Chinese food and drug testing institute issued a record of reference to the preparation of the ginseng and other preparations.
The reporter visits the provincial bureau to learn, the current walk in the front is guangdong, zhejiang, jiangsu, fujian and so on. In the first half of guangdong province, the quality of generic drugs and the conformance of the efficacy of generic drugs were assessed to be 421, the largest number of provinces and cities in China. In Shanghai, there have been 31 enterprises with 108 varieties of specifications for the registration of reference reagents; An evaluation of 267 generic drug Numbers in zhejiang province; In fujian province, there are 396 cultivars to carry out conformance evaluation.
Anhui, shandong, sichuan and other provinces have used the compensation policy to encourage enterprises to carry out consistent evaluation work. Anhui province has established a platform for political research and development. The government has issued a subsidy policy of RMB 1 million to 3 million yuan, and the provincial government has conducted a consistent evaluation of 51 varieties in 19 enterprises. Shandong province has promoted the establishment of a generic drug consistency assessment of provincial awards, and awarded prizes to three enterprises that passed the evaluation through evaluation, and the highest award of the single variety in jinan was 4 million yuan. A total of 347 varieties have been evaluated in the whole province, and 50 varieties have been studied in vitro pharmacology. In sichuan province, a total of 1 million to 2 million prizes were awarded for the three types of conformity assessment in the country.
Some work starts later in provinces and cities, and now also increases the speed of work. In jiangxi province, there are 13 enterprises and 25 key cultivars to carry out generic drug consistency evaluation. Chongqing will have to complete more than 380 batches by the end of 2018, and 76 of them have been launched. In liaoning province, 25 drug manufacturers initiated a conformance evaluation study involving 79 approval Numbers.
In view of the present work to promote the overall situation, experts at the meeting made it clear that: "from the current registered declare, under the precondition of not to reduce the number of varieties, the drug approval document for structural adjustment is expected to achieve it."
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