From 2015 to now, we have witnessed some milestone events in the pharmaceutical field in China, such as the reform of the drug review and approval system in 2015, the launch of the consistency evaluation of generic drugs, the ICH in 2017, and the drug patent link system in 2021. For example, we are currently on the way to join PIC / S. As we all know, the consistency evaluation of generic drugs in China is a historical remedial lesson, of great significance and far-reaching. The consistency evaluation of generic drugs aims to improve the overall quality level of China's drugs and accelerate the upgrading and adjustment of China's pharmaceutical industry. For pharmaceutical enterprises, the general principle of the country is to say, and the driving force to do this and the input-output ratio are to be weighed.

 On March 21,2018, the State Council General Office issued "The General Office of the State Council on reform and improve the generic drug supply security and use policy opinions", has been clear about the series requirements and measures to promote generic drug research and development, encourage through consistency evaluation of drugs to replace the original drug, to better meet the demand of clinical medication, speed up our country from pharmaceutical power to pharmaceutical power. The consistency evaluation of generic drugs means that generic drugs must have the high standard requirement of "management consistency, consistency in the middle process, quality standard consistency and other whole process consistency" of the original research drugs. After completing relevant experiments, enterprises should submit materials to prove the consistency of their products and the original research drugs. It is difficult and expensive to promote the consistency evaluation of generic drugs, but it is of great significance. On the one hand, to improve the overall quality level of drugs, on the other hand is also conducive to improve the quality of pharmaceutical excipients, packaging materials, accelerate the evolution of evolution, transformation and upgrading, enhance the level of preparation production in China, further promote our pharmaceutical products to the international market, improve the international competitiveness.

 The overall investment in the process of product declaration consistency evaluation is large, and the comprehensive cost is generally increased after the evaluation. On May 12,2020, the State Medical Products Administration issued the Announcement of the State Food and Drug Administration on the consistency Evaluation of quality and Efficacy of Generic Chemical Injections (No.62,2020), which officially launched the consistency evaluation of injections. According to the third party statistics, the average a product from the declaration to the consistency evaluation, including the cost of basic research, probably need to cost 3 million-5 million yuan, during the raw materials and packaging materials to the selection, production equipment, the optimization of production process, enterprise GMP compliance inspection series of work. On the whole, the comprehensive cost of drugs that pass the consistency evaluation of generic drugs is higher than that of the same drugs that fail to pass the consistency evaluation.

 Whether the enterprises that actively respond to this work will get the due output and return, and what support policies, these are the most concerned issues of the enterprises.

 In order to encourage enterprises to actively participate in the consistency evaluation of generic drugs, the state stipulates that after evaluating the three companies, they will no longer choose the unevaluated drugs in the aspects of drug collection and acquisition, and no longer only take low prices, which shows the state's determination to improve the quality of drugs. Document no. 13,2017 further emphasizes that: for the manufacturers with more than 3 drugs that have passed the consistency evaluation, no longer choose the varieties that have not passed the consistency evaluation in the centralized drug procurement; for no more than 3 drugs, give priority to purchasing and using the varieties that have passed the consistency evaluation.

 The National Medical Insurance Administration requires enterprises to follow the principle of quality and price consistency when setting prices, allowing drug prices to reflect cost changes and market supply and demand; the national and provincial network access policies also allow the moderate price increase of evaluated products, and quality is the first factor.

 On December 6,2019, the national health care security bureau issued by the opinions on the current drug price management work, mentioned to adhere to the market regulation of the overall direction of drug prices, drug operators (including marketing license holders, production enterprises, enterprises, etc., similarly hereinafter) prices should follow the principle of fair and honest and credit, quality, make the drug prices reflect the cost change and market supply and demand, maintain reasonable and stable prices. In this sense, the cost of overevaluated drugs is higher and the quality is better, and the price should match the quality. Only by making the enterprises that pay attention to product quality maintain a reasonable profit space, can the enterprises have the impetus for further innovation, and the whole pharmaceutical industry will develop more healthily and sustainably.

 In most provinces, we open a green channel for the evaluation of generic drugs, and the price is higher than the price of the original research drugs. In some provinces (such as Guangxi, Shanxi, Hebei, etc.), the price difference between drugs at the same level. These policies basically ensure that the price of evaluated drugs is scientific and reasonable. Considering that the quality of unevaluated drugs can not be compared with that of unevaluated drugs, and the state has clarified the policy of suspending the network of 3 unrated products, no province has made clear requirements on the price difference between unevaluated generic drugs and unrated drugs.

 The consistency evaluation of generic drugs can be consistent with the original drug in terms of quality and efficacy, and can be replaced with the original drug clinically. Compared with the high price of the original drug, the use of evaluated generic drugs can greatly reduce the economic burden of patients with the same treatment effect, and also play a double-layer role in saving the medical insurance fund. The trust and stubbornness of the original medicine, and their long-term medication habits are difficult to be changed in the short term. Not to mention the PK of the product and the original drug, but also the game between the product.

 Before has been calling for the product after the review, after all, the quality and price are consistent. But after the start of price management in the second half of 2023, it is almost impossible to increase the price. Many enterprises just stuck at this point, hanging out a part of the province, and a part of the province is still low prices, the network channel is also sealed. The early investment may be wasted, now the national monitoring price is basically given according to the product code, if the low price before the evaluation is large, it is likely that your monitoring price is low. Now the provincial implementation of the monitoring price policy, is more rough, on the one hand, allowing enterprises to appeal, on the other hand, said that the monitoring price is formulated by the National Medical Insurance Bureau, they have no right to modify, can only help enterprises online feedback. It is to help enterprises feedback, but the actual acceptance of the appeal is still simple and rough, not considering the difficulties and embarrassment caused by the policy transition period to enterprises, do not recognize the price explanation before and after the transfer of the factory, or even considering whether you have an actual transaction, what is the significance of the zombie price?The early investment of the enterprise can not be avoided, but do not often use credit rating to frighten the enterprise. The author also learned the terms of credit rating, can be rated because of the price factor is very serious degree.

 National mining from the pilot is the national implementation, the first response to the enterprises, really divided into the consistency evaluation and national mining of a big cup of hot soup, but the latter enterprises may not be. Now the price limit of national mining is more and more strict, the selected price is more and more volume, even many enterprises, especially group companies, even won the bid at a loss, the logic of choosing the province is no longer "selective admission", but which province I choose which, because I am willing to lose, but I do not want to lose too much. People who do not know will certainly ask why you want to win, it is because my enterprise needs positive energy, I need a lot of added value and halo selected by the country. Although real world research has been conducted at the national level, the quality of generic drugs can be evaluated and the PK of the original drugs. However, as a vulgar and poor person, I still spend money to buy medicine as much as possible unless I can not buy it out of stock, not because I want to spend this money, but I dare not risk easily and test medicine by myself.

The tenth batch of national mining has been on the way, it is said that the catalogue selection has been completed, and the report is expected to start in April, the specific will be subject to the official announcement. It is expected that the enterprises that have invested a lot of money and effort in the consistency evaluation, especially the products with relatively small products, can seize the opportunity of national mining, plan and fully prepare to earn back the investment as much as possible.