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Import of Reference Preparations: The Generic Drug Market is Experiencing a large-Scale Readjustment

Date: 2020-02-19
浏览次数: 110

Amoxicillin Capsules, escitalopram oxalate tablets, entecavir dispersible tablets, entecavir capsules and other four drugs have reached three manufacturers through the conformity assessment of quality and efficacy of generic drugs. The trading qualification of the drug centralized purchase platform in some regions of the above drugs that failed to pass the conformity assessment of quality and efficacy of generic drugs has been suspended.

Temporary adjustment of the market

Amoxicillin is a famous drug. Moreover, with the continuous promotion of consistency evaluation, the drug market is expected to accelerate the adjustment.

According to the previous announcement, there are 241 domestic approval documents and five import approval documents for Amoxicillin Capsules in China. There are many companies in the manufacturers with relatively high sales volume.

Amoxicillin Capsules produced by a company can expand the market share of the drug and enhance the competitiveness of the market through the consistency evaluation of generic drugs. Meanwhile, valuable experience has been accumulated for the company's follow-up products to carry out the consistency evaluation of generic drugs.

According to the data released by the national drug review center, at present, there are more than three pharmaceutical enterprises that have passed the consistency evaluation of amoxicillin 0.25g product specification, namely Hunan Kelun Pharmaceutical Co., Ltd., Zhejiang Jinhua Kangenbei Biological Pharmaceutical Co., Ltd., Zhongshan branch of Zhuhai federal Pharmaceutical Co., Ltd. and Shiyao group.

Acceleration of market pattern adjustment

Because drugs through conformity assessment are the focus of national policy support. According to the latest information released by the State Food and drug administration, linkage with conformity assessment is realized. If the drugs that have passed the consistency evaluation are included in the catalog preferentially, if the drugs that have not passed the consistency evaluation will be gradually transferred out of the catalog. For drugs that have been included in the national essential drug catalogue, the time limit for evaluation can no longer be set uniformly.

In addition, the State Food and drug administration also proposed to strengthen the guidance of basic services, and to fully promote the consistency evaluation. It is proposed to establish a green channel to speed up the review progress of conformity assessment application. If an enterprise encounters major technical problems in the course of research, it may, in accordance with the relevant regulations, communicate with the drug evaluation institution. And further strengthen the guidance of key varieties and key enterprises, organize on-site investigation and communication, so as to help enterprises solve difficult problems.

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