The time for the consistency evaluation of generic drugs is approaching, and then hear the price cuts of the original research drugs

Yesterday (December 25), "daily economic news" reporter learned that, by the end of this year, the State Food and Drug Administration will complete the consistency evaluation of 75 generic drugs, and plan to comprehensively improve the quality and safety standards of drugs On December 23, a policy research expert of the health and Family Planning Commission disclosed to the big wisdom news agency that the state is promoting the consistency evaluation of generic drugs, aiming to protect high-quality generic drugs "If there is no difference between the consistency of generic drugs and the original research drugs, there is no sufficient basis to prove the independent pricing, so the qualification of single pricing should be cancelled." Zhao Zhen, an analyst of Zhuo Chuang information pharmaceutical industry, believes that the long-term tolerance of high prices of original research drugs at the policy level is related to the difficulty of most generic drugs in China to reach the level of original research drugs at this stage, which is also a reason why the management is hard to make up their minds Recently, the generic pharmaceutical industry is facing a reshuffle Some media pointed out that after the results of generic consistency evaluation were released, those with excellent quality and effect of generic drugs can narrow the price gap with imported original research drugs, and more easily enter the medical insurance and the bidding system of all regions If they are unqualified, they will be delisted The consistency evaluation of generic drugs will promote the overall "reshuffle" of chemical pharmaceutical industry, which will be beneficial to companies with strong R & D technology and integrated producers of raw materials and preparations, such as Hengrui pharmaceutical, Huahai pharmaceutical, modern pharmaceutical, etc Chen Zhefeng, senior consultant of Qinmai pharmaceutical consulting, said frankly that 94.7% of the existing 189000 drug marketing licenses in China were issued before the implementation of the new measures for the administration of drug registration in 2007, far lower than the current listing approval standards For this reason, on February 13, 2012, the State Council issued the 12th Five Year Plan for national drug safety, which clearly requires that generic drugs approved before the implementation of the revised Measures for the administration of drug registration in 2007 should be evaluated for quality consistency with generic drugs by stages and batches, and "historical supplementary Courses" should be conducted The main impact of generic consistency evaluation is on the industry concentration, and many enterprises will be eliminated According to Zhao Zhen, there will be more interest disputes in the indicators set and standards selected for the consistency evaluation of generic drugs, and the consistency evaluation may not be so smooth However, it is also a huge challenge to complete the task of conformity evaluation of generic drugs According to the statistics of relevant data, the United States launched bioequivalence evaluation in 1971, which lasted for 10 years, and eliminated 6000 drugs; Japan launched the "drug quality re evaluation project" in 1997, which has completed about 730 varieties so far; and to complete the re evaluation of more than 100000 generic drugs in China, the State Food The State Food and drug administration is under great pressure on human resources and technical reserves Guo Fanli, manager of CIC's consulting industry research department, told the daily economic news that under the impact of the policy of conducting generic consistency evaluation, the generic pharmaceutical industry is facing a new round of reshuffle, and those small and medium-sized pharmaceutical enterprises that are unable to follow up the technology upgrading are bound to fall into crisis, "but from another perspective, it will promote the transformation and upgrading of domestic pharmaceutical enterprises and indirectly accelerate the pharmaceutical industry The transfer of industry from imitation to creation " For a long time, the original research drugs and generic drugs have been competing with each other on the same platform The original research drug is a unique concept in China In 1993, China began to implement the drug patent protection policy, but before that, the patent drugs entering the Chinese market lacked legal protection Therefore, the state introduced such a retroactive administrative protection system, enabling foreign pharmaceutical enterprises to obtain economic compensation, and also encouraging them to bring innovative drugs to China But GSK's "bribery door" in China has opened the window for the price reduction of original research drugs Sun Zhigang, deputy director of the national health and Family Planning Commission, made it clear at the national bidding symposium that we should reduce the super national treatment of the original research drugs and let the original research drugs compete with the generic drugs If the price of the original research drugs can't be reduced, the country will gather together, and the country will negotiate and judge the price, or even unify the pricing The reporter found that in recent domestic bidding policies for basic drugs and non-basic drugs in various provinces and cities, there are restrictions on the original research drugs Even in some provinces and cities' drug bidding documents, the independent bidding qualification in the original research drug bidding has been cancelled At present, in the future pharmaceutical market, foreign drugs with expired patents will compete directly with generic drugs on the same platform, which is the general trend In such a policy environment, foreign pharmaceutical companies that are reluctant to reduce their prices begin to abandon bidding Guo Fanli believes that the independent pricing of original research drugs can promote drug innovation and mobilize the enthusiasm of enterprises to invest in drug research and development, so it is unreasonable to cancel the independent pricing of original research drugs However, it is reasonable for generic drugs to cancel the qualification of independent pricing, that is to say, it is based on the original research drugs, has an advantage in cost and affects fair competition in the market, so it is necessary to promote the policy level.