Since the reform and opening up, with the continuous advancement of medical technology, China's drug review standards have been continuously improved. Past drug review standards have not mandated that generic drugs are consistent with the quality and efficacy of original drugs, so some drugs have certain efficacy and original drug. The gap needs improvement and improvement. Carry out the conformity evaluation of generic drugs to ensure that the generic drugs are consistent with the original research drugs in terms of quality and efficacy. It can not only save medical expenses but also improve the quality of generic drugs and the overall development of the pharmaceutical industry. Level to ensure that public medication is safe and effective.

A reference preparation is a control drug used for the evaluation of the quality and efficacy of a generic drug, usually a generic object, such as an original drug or an internationally recognized drug of the same type. The reference preparation should be a medicine with reasonable prescription process, stable quality and exact curative effect.

The state encourages enterprises to actively carry out the evaluation of the consistency of essential drug varieties. The work on the consistency evaluation of essential drug varieties and the dynamic adjustment of the essential drug list were promoted. The National Essential Drugs List (2018 edition) was implemented on November 1, 2018. The old catalogues were greatly adjusted. The basic drug catalogue has established a dynamic adjustment mechanism. The varieties that have passed the consistency evaluation are preferentially included in the catalogue. The varieties that pass the consistency evaluation will be gradually transferred to the catalogue, so the evaluation time limit is no longer set separately for the essential drug varieties. For the generic drugs containing the basic drug varieties approved before the implementation of the new chemical registration classification, the same varieties of other pharmaceutical manufacturers should be evaluated in three years in principle after the first varieties have passed the consistency evaluation.

Considering the clinical needs of drugs, there are regional and time-sensitive features. In order to ensure the market supply and the accessibility of the people, if the enterprise fails to complete the evaluation according to the above requirements, it is considered to be a clinically necessary and market-disabled variety. Submit an application for deferred evaluation to the local provincial drug regulatory department, explain the reasons and provide an evaluation report. The provincial drug regulatory department and the health administrative department organize research and demonstration. If the research is determined to be clinically necessary and the market is short of varieties, it may be extended appropriately. Not more than 5 years. At the same time, for the varieties that agree to postpone the extension, the provincial drug supervision department and the relevant departments should continue to guide, supervise and support the enterprises to carry out evaluation work. If it is still not completed by then, the drug regulatory department will not approve the application for re-registration of the drug.

Mingren Medicine has a wide range of stable supply channels at home and abroad, including more than ten years of cooperation with European, American and Japanese partners. Mingren Medicine has been cultivating in the pharmaceutical industry. It is well aware that the stable supply of medicines and product quality are major events related to the national economy and the people's livelihood. On the occasion of the transformation of the pharmaceutical industry, we have launched a one-stop compliance solution for reference preparations, which is consistent with China's generic drugs. Sexual evaluation adds bricks and tiles. For details of our services and advantages, please refer to Mingren Reference Preparation Mall http://www.mrrld.com.