Bi Jingquan: one of the main reasons for the slow marketing of new drugs is the small number of approvers

[interview with people on chinapharma.com] at present, the approval of drugs in China is slow, which leads to the late listing of new drugs in China than in other countries On the morning of March 5, Bi Jingquan, director of the State Food and drug administration, said in an interview at the "two sessions minister channel" in the Great Hall of the people that the current squeeze on drug approval has improved significantly From a high of 22000 to 8000 at the end of last year Bijingquan pointed out that one of the main reasons for the slow marketing of new drugs is the low number of drug approval centers (Bi Jingquan: the small number of approval is one of the main reasons for the slow listing of new drugs Picture source: Baidu picture) minister Bi raised four reasons for this, which has institutional problems In China, it is required that the drug can be applied in China only after the first phase of clinical trial Second, the protection of domestic intellectual property rights is not perfect, and foreign pharmaceutical companies dare not list in China Third, the adjustment of medical insurance reimbursement catalog is not timely, and pharmaceutical companies are worried that they will not be able to recover costs The latter is due to the lack of approval staff Mr Bi said the number of drug approval centers in the U.S stood at 5000, while the number of drug approval centers in China rose to 600 at the end of last year after efforts by the China food and drug administration At present, CFDA is actively negotiating with relevant departments to solve problems, canceling unreasonable requirements, strengthening the intellectual property system, and improving the efficiency of examination and approval by optimizing the process and increasing efficiency Director Bi also talked about the listing of foreign multinational pharmaceutical companies in China He said that with a population of 1.3 billion and a huge market potential, China has also adjusted the medical reimbursement catalogue for this purpose, and the country hopes foreign drugs will come to China to apply for listing Later, a reporter also asked about the "drug marketing license holder system", which encourages researchers in the industry greatly I hope director Bi will describe the implementation of the system To this end, director Bi said, "the" drug listing permit holder system "is an internationally accepted system." In the past, China limited the drug marketing license to manufacturing enterprises, including the application for drug clinical trials The implementation of the "drug marketing license holder system" is conducive to stimulating the enthusiasm of scientific researchers "From selling young crops in the past to selling finished and semi-finished products behind, the price of selling young crops is different from selling finished and semi-finished products." Second, the "drug listing license holder system" allows the holders who have obtained the drug listing license to bear all the legal liabilities, while the production enterprises and distributors only accept the entrustment and do not bear the legal liabilities This system can improve the problems of small, scattered and disorderly drug manufacturers and distributors in China In addition, the "drug listing license holder system" is conducive to promoting the "supply side" reform of the pharmaceutical industry Last year, the State Food and drug administration has launched a pilot program, hoping to spread the system as soon as possible in the future.