Medical network on July 24 - July 4, the food and drug verification research institute of China announced on June 20, 2017 enterprises during the reference preparations for the record, a total of 5495 enterprise product gauge was registered. The June 2017 corporate filing is expected to hit a record low again.
289 varieties: the risk of elimination is high
The CFDA until the end of 2018 on the quality of generic drugs and curative effect of complete consistency evaluation varieties approval number information ", must be completed by the end of 2018 generic drugs quality and curative effect evaluation of varieties of consistency approval number is 17740, corresponding to 289 common name. The record of the company's reference to the conformance cultivars is still not optimistic. Only 2,781 enterprises participate in the preparation of the formulations, and about 84% of the approval Numbers may not initiate the consistency evaluation.
Among the 289 generic quality and efficacy consistency evaluation varieties, the approval number of the top 20 products in the top 20 products was 9059 approval Numbers, accounting for 51 percent of the 289 target approval number. In the first 20 products, there are only 703 items for filing, accounting for 8 percent of the 9059 approval Numbers. Therefore, about 92 percent of the approval Numbers have the risk of elimination.
Table 2. 289 the record of the top 20 products in the approved document
(source: sensitive information)
On July 21, the seventh and eighth batches of the generic drug reference preparation catalogue released a number of 289 species of reference preparations. Before approval number number 20 products, berberine hydrochloride, norfloxacin capsules, vitamin B2, nifedipine, cephalosporins capsule, sodium bicarbonate pills six product still has not released by the national reference preparation directory.
Before product gauge number of 20 products belong to 289 generic drugs quality and curative effect evaluation of varieties products, consistency of benzene sulfonic acid amlodipine, simvastatin pills, clarithromycin tablet and omeprazole enteric capsules and loratadine tablets the enterprises for the record to gauge number is more than the number of drug approval number, fully illustrates the cluster is very serious.
Table 3 record of the first 20 products of enterprise record
(source: sensitive information)
In addition to cefradine capsules, norfloxacin capsules and berberine hydrochloride tablets in the first 20 products, the state has published relevant reference preparations.
Injection: existing layout
In May 2017, the administration about asking about encouraging drugs medical equipment innovation implementation drugs in whole life cycle of medical instrument management policies "(draft) of announcement no. 54 (2017), the first it takes 5 to 10 years to carry out the public injection evaluation again.
At present, 169 injection enterprises have been put on record, with the largest number of injections in the number of sodium pantolazole. The use of ptoprazole sodium for injection by hainan pui pharmaceutical co., ltd. has been approved and approved by the eu GMP inspection. As shown in table 4, the number of injectables is more than that of many people, with proton pump inhibitors and narcotic drugs.
The original research real estate products: the declaration of less than the preparation
In June 2017, administration of the general office of inviting public on the quality of generic drugs and curative effect evaluation of consistency (draft) "announcement of relevant matters in opinion, for the original real estate products, namely the original enterprise production listed varieties in China, if not big change after listed, or after the listed larger change but by the review does not affect the quality and curative effect, after approved by the food and drug supervision administration and verification, can choose for the reference preparation.
Declaration from 589 cases as you can see, the current situation of the original declaration of property change, such as Pfizer atorvastatin calcium tablet, benzene sulfonic acid amlodipine tablets, fluconazole capsule, sildenafil citrate tablets, doxycycline hydrochloride, novartis carbamazepine tablet and diclofenac sodium enteric-coated metformin hydrochloride and valsartan capsules, bei that split hydrochloride, bayer acarbose tablets, aluminum magnesium carbonate, nim to plain radiographs and vitamin C effervescent tablets, are likely to have property or points packaging. However, from the available information available, there are not many products in the original study.
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289 varieties have a greater impact: the grassroots release of non-basic drugs
289 generic drugs quality consistency and efficacy evaluation variety products belong to the list of essential medicines, the original policy is to ensure the quality of essential drugs, and grassroots medical institutions can only use drugs, the amount of secondary and tertiary preference based medicine guarantees, as consistency evaluation policy support.
To promote two-way referral, establishing the hierarchical diagnosis and treatment, different payment level and the grassroots, linking to the local public hospital medical city community health service centers and rural towns and townships of the use of medicine is inevitable. Jiangxi allows primary medical institutions to use 30 to 40 percent of non-essential drugs; Chongqing is allowed to use 50% of non-basic drugs; Hubei is 20%. A total of 12 provinces, such as zhejiang, shandong and shaanxi, have adopted a partial liberalisation of the drug use of primary medical institutions.
Recently the guangdong health commission on further clear the basic drug system in our province on the requirements of the notice, in guangdong province as the unit for the first time as a big opening, at the base of basic medicine usage is expected to impact. This means that the products of the 289 catalogue products that are not attractive to enterprises will continue to be neglected in the future if there is no further good news to promote the imitation of enterprises. |
