CFDA states that new drug approvals will be accelerated or government purchase services will be adopted

Source: Southern Metropolis Daily on November 6, 2014, Yin Li, deputy director of the State Food and drug administration, said that the government's purchase of services will become an important means to improve the efficiency of drug approval For new drugs to go on the market, first of all, they have to pass the drug review, and the efficiency of drug review has been a controversial topic Many pharmaceutical companies feel that the current drug review is too slow However, it is also believed that the first meaning of drug approval is "safety" In the case of limited existing systems and resources, the slow approval is the price paid for safety According to Yin Li, under the background of learning from international experience, the newly revised Measures for the administration of drug registration will be more oriented, and the administrative approval matters for CFDA will be further reduced In addition to entrusting some drug registration applications to the Provincial Bureau and gradually realizing the review and approval pattern of classification responsibility and mutual support between the State Administration and the Provincial Bureau, we will also study and improve the new drug review charging policy, and adopt the way of government purchase services to solve the outstanding problem of shortage of drug reviewers The shortage of personnel slows down the speed of evaluation At present, a new drug generally goes through two stages from the beginning of research and development to the final approval for listing The first step is to develop and market new drugs A new drug must first apply for clinical trials and start clinical trials after obtaining the approval After successful development, it needs to be registered and approved before it can be put on the market According to the insiders, generally speaking, this process will take at least 4-5 years For example, Kemena, an anti lung cancer drug developed by Zhejiang Beida Pharmaceutical Co., Ltd., which was launched in 2011, applied for clinical trials in October 2005, obtained the approval for clinical trials in June 2006, applied for new drugs in July 2010 and obtained the approval for new drugs in June 2011 Some industry insiders have disclosed to Nandu reporters that this is even faster It's only the first step in the long march to get the approval of new drugs Drugs still need to enter the market for sale In China, when drugs enter hospitals for sale, they must pass the provincial access and hospital access, which means drug bidding IMS research shows that the average bidding period of 31 provinces in China is 14 months If it fails to catch up with the 14 months, it can only wait until the next period After winning the bid, hospital procurement is required Most hospitals only hold a pharmaceutical Committee once a year or two to select drugs Data shows that only 20% of the new drugs launched in the past five years have obtained access to 11-13 provinces in the second year, and 30% of the new drugs still fail to enter any province after two years of launch Next, if the new drug wants to become a reimbursable drug, it needs to enter the national health insurance catalog, which may be a longer process After a new drug is put on the market, it needs a five-year monitoring period before it can enter the Pharmacopoeia Only when it enters the Pharmacopoeia can it enter the medical insurance However, the updating cycle of national and provincial medical insurance catalog is long, which is updated once every 4-5 years, and it will be delayed for 1.5 years until the real updating Combined with the above factors, compared with other countries such as the United States, patients will be about 8 years late in drug use due to the lag of drug listing and reimbursement qualification in China Hu Shanlian, School of public health management, Fudan University, told reporters, "in general, the molecular research of a new chemical drug needs to go through nearly 20 years, clinical phase I, phase II and phase III trials to prove its efficacy is safe and reliable Then it enters the patent period and then enters the market If it wants to come to China, it needs to repeat clinical trials In addition, if it wants to be listed in the medical insurance reimbursement catalogue of China, it needs to be approved again, which involves bidding between regions All of these delay the time when our new drug approval is in the hands of patients " Lack of approval staff? In view of the slow speed of new drug approval, many people in the industry first attribute it to the lack of resources, mainly the lack of manpower Yu Mingde, President of the pharmaceutical enterprise management association, pointed out that "in terms of personnel allocation, countries with fast approval, such as the US FDA, have more than 4000 people, the European Drug Administration (EMA) has more than 3000 people, while China's CFDA only has more than 100 people, who are responsible for a large number of drug approvals every year The average annual approval volume of the national food and drug review center is about 7000, and there are still more than 14000 drug projects waiting for review " According to Hu Shanlian, "the approval of new drugs in China is relatively late, because China is not included in the reimbursement of medical insurance immediately after the production of new drugs like the United States, and our funds are limited, so we cannot be included in the reimbursement of medical insurance immediately." In addition, new drugs can be approved or listed as soon as possible, of course, it is a beneficial aspect for patients But the medical and health systems in different countries are different In addition, there are some difficulties in the source of health funds The general problem of our basic drugs is not very big The price of these patented new drugs is particularly high, which also makes it difficult for them to enter the scope of reimbursement " Some industry insiders engaged in pharmaceutical research and development believe that CFDA is not the only one responsible for the slow approval of new drugs in China The real problem is that the registration of generic drugs in China is seriously blocked The problem is that patents are still waiting for expiration CFDA has to study the priority review of generic drugs Many imported new drugs, if foreign enterprises do not care about the cost of research and development, will go to China for clinical practice (not limited to international multi centers) before FDA approval, and can be listed in China within 1-3 years after FDA approval Some insiders of the drug regulatory system told reporters, "the total number of CFDA is more than 300, which can not be increased if CFDA wants to increase If we count the number of provincial bureaus, it is quite a lot, but it was not easy to take the local examination and approval right back to the country at that time If we choose between the slow examination and approval speed of the National Bureau and the confusion of local examination and approval, I think the former is better It is also a way to entrust a third party, but who is the third party and how to supervise it is a problem " In addition, China's drug review is facing a low level of repeated applications, which wastes limited resources to a certain extent According to the 2013 annual drug review report (hereinafter referred to as the "report") released by CFDA on its website recently, in 2013, the drug review center of State Food and Drug Administration accepted 7529 new registration applications (calculated by acceptance number, excluding reexamination), an increase of 8.8% compared with 2012, including 6409 chemical drugs, 594 traditional Chinese medicine and 526 biological products Compared with 2012, the status of low level and repeated applications for registration of chemical generic drugs has not changed According to the report, there were 2427 new applications for chemical drug imitation and dosage form modification (anda) in 2013 Among them, there are 1039 drug applications with more than 20 approval numbers, accounting for 42.8% of the total annual ANDA applications; there are 932 drug applications with less than 10 approval numbers, accounting for 38.4% of the total annual ANDA applications Due to the large number of applications, the efficiency of the evaluation of the application for copying and changing dosage forms and the application for the production and marketing of new drugs has decreased correspondingly The waiting time for the review of the former was extended from 24 months in 2012 to 34 months, while the latter from 12 months to 14 months In response, the head of the drug evaluation center of the State Food and Drug Administration said that the center is cooperating with the State Food and drug administration to promote the construction of the priority evaluation system for generic drugs in clinical needs For example, 89 varieties of drug patents that are about to expire in 2013-2014 have been sorted out, and 62 of them have been applied to drug review centers to determine the priority review strategy Recently, a Yale University study showed that during 2001-2010, compared with drug regulatory agencies in Canada and Europe, the U.S FDA reviewed new drug applications faster and more frequently According to the study, most new drugs are approved within one review cycle, but this proportion is the highest in EMA (96%), while FDA and HC are 62% and 69%, respectively The median time to complete the first review (the number of days between the submission of the application and the notification of the decision by the drug regulatory agency) was 303 days for FDA, 366 days for EMA and 352 days for HC Among the 72 new drugs approved by three organizations, FDA is 254 days, EMA is 356 days, HC is 346 days It is reported that the approval of PDUFA in 1992 gave FDA the right to charge companies applying for new drugs, which was used to speed up the review process, including hiring additional staff The bill is reauthorized every five years and will be reauthorized this year This year, FDA has discussed with the pharmaceutical industry how to make the new drug and biologics review process more efficient and how to increase the number of drugs approved in a single review cycle.