Drug registration verification storm is still fermenting. On December 25, the State Food and Drug Administration disclosed on its official website that Bi Jingquan, director of the General Administration, said at a recent symposium on drug clinical trial data verification that it is necessary to speed up the promotion of the drug marketing license holder system and the consistency evaluation of generic drugs, and rebuild the ecology of drug research and development.
Lin Li (pseudonym), the R & D leader of a listed pharmaceutical company in Guangdong, told the reporter of ''Daily Economic News'' that clinical trials with rigorous specifications and reliable data are a key safety barrier before the drug goes on the market. After this round of verification storm, overcapacity, Generic drugs with low-end competition will face the impact of industry reshuffle, and the production and R & D costs of enterprises will also rise one after another.
Drug registration threshold increased
The self-examination and verification of drug clinical trial data launched in late July this year caused a strong "shock" in the industry ". As of December 17, more than 200 enterprises have voluntarily withdrawn 727 drug registration applications. This, Lin Li is not surprised. She told the "Daily Economic News" reporter that clinical data fraud is an open secret of the industry, and more companies will take the initiative to withdraw new drug applications.
"Clinical trials are a highly professional and complex process from design, experimental operation, statistical analysis of data to application for approval, but the problems of unreliability, untruth and fraud are more serious." Lin Li said that although many domestic generic drugs are consistent with the original drug in chemical structure, there is still a gap in process and actual clinical application.
Bi Jingquan said frankly at the symposium that the untrue and incomplete clinical trial data and the irregular clinical research behavior have profound historical and social reasons. Since the reform and opening up, the pharmaceutical industry has made great development, and the problem of drug accessibility has been basically solved. However, there is still a big gap between the quality of some drugs and the quality and efficacy of the original research products. The foundation of drug research and development is weak, the management and supervision of clinical trials are weak, and the power of drug technical review is weak.
Enterprises take the initiative to withdraw the drug registration application, which means that the previous investment or water drift. The reporter noticed that the announcement issued by Renfu Pharmaceutical showed that the holding subsidiary Yichang Renfu Pharmaceutical Co., Ltd. has invested about 3 million yuan in the research and development project of amlodipine besylate tablets recently withdrawn. The enalapril and felodipine sustained-release tablets withdrawn by Baiyunshan Pharmaceutical General Factory, a subsidiary of Baiyunshan, have invested about 650 yuan in research and development.
"Relatively speaking, the research and development cost of generic drugs is relatively low, but the work before the application is withdrawn is done in vain." Lin Li said frankly that with the regulatory authorities raising the threshold for drug registration applications, institutions with clinical trial qualifications are currently afraid to accept orders easily, "the price is three or four times higher than before, and they are afraid to take responsibility."
It is understood that at present, only more than 400 clinical trial institutions in China have relevant qualification certification, most of which are top three hospitals in various regions. An executive of a large pharmaceutical company in Jiangsu, who spoke on condition of anonymity, told reporters that the situation of more monks and less porridge will push up the cost of clinical trials within three to five years.
Generic drug companies will shuffle
In addition to waiting in line for approval of new drugs, generic drugs will also usher in the most severe reshuffle. According to relevant announcements, for the oral solid preparations of chemical drugs in the national essential drug list approved before October 1, 2007, the consistency evaluation should be completed before the end of 2018. If the evaluation fails at the expiration, the drug approval number will be canceled. For other generic drugs approved for listing before 2007 and generic drugs approved for listing after 2007, after the first variety has passed the consistency evaluation, if the same variety of other production enterprises fails to pass the evaluation within 3 years, the drug approval number shall also be canceled.
The relevant person in charge of Guangdong Saifeng Pharmaceutical Technology Co., Ltd., which provides consistency evaluation services for pharmaceutical companies, believes that in the early era of lack of medicine and drugs, the regulatory authorities adopted a relatively loose policy to let a batch of generic drugs go on the market first. However, with the development of the times, many products have been unable to keep up with the demand in quality, and consistency evaluation is needed to improve the quality of drugs. This means that it takes longer and costs more for pharmaceutical companies to apply for a drug registration, and the industry will usher in a new round of cruel "knockout rounds".
According to the statistics of the Food and Drug Administration, there are nearly 5000 pharmaceutical companies in China, with generic drug companies accounting for more than 90%. Among them, the total number of existing drug approval numbers is as high as 189000, and more than 95% are generic drugs. For large pharmaceutical companies with strong financial strength and stable product market, this competition is undoubtedly good.
Dong Mi, a listed company in Guangdong, said that the original research drugs in the industry where its core varieties are sold for hundreds of yuan a box. Many domestic generic drugs are around 10 yuan, and some are even only 5 yuan. The price difference is 20 times, which has triggered the market. Vicious competition, "This verification is a disaster for non-compliant small and medium-sized enterprises, and many will be cleaned out."