Reform of the review and approval system for drugs and medical devices: people's health needs review reform without stopping
Since the implementation of the review reform in 2015, the State Food and Drug Administration has reviewed and approved 95 innovative drugs and approved 155 innovative medical devices.
5 new coronavirus vaccines were approved for conditional listing, 2 new coronavirus vaccines were approved for emergency use, and 34 vaccine varieties with 5 technical routes entered clinical trials.
106 new coronavirus detection reagents were approved, including 38 nucleic acid detection reagents, 37 antibody detection reagents, and 31 antigen detection reagents.
"The quality of registration application materials is not high, and it needs to be supplemented and improved many times during the review process, which seriously affects the efficiency of review and approval; repeated construction and repeated applications for generic drugs, vicious market competition, and there is a big gap between the quality of some generic drugs and the international advanced level; The marketing approval time for new drugs urgently needed in clinical practice is too long, and drug R&D institutions and scientific researchers cannot apply for drug registration, which affects the enthusiasm for drug innovation."
This is a frank and sharp analysis of the problems of medicines and medical devices that are related to people's lives and health in a State Council document seven years ago.
This analysis resonates with the confusion of the common people: why are some drugs "half a beat slower" than abroad?
Why do some people go overseas to buy medicines?
The full name of the State Council document is "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices", which was issued in August 2015, which opened the prelude to the reform of my country's drug and medical device review and approval system (hereinafter referred to as the review reform). .
In particular, since the establishment of the State Food and Drug Administration in 2018, it has continued to deepen the review reform, encourage innovation in drugs and medical devices, improve the quality of drugs and medical devices, increase effective supply, and effectively protect the health and safety of the people.
1. The backlog of registration applications has been resolved
The quality of drugs and medical devices is related to everyone's health and safety, which is the original intention of implementing the review and approval system.
However, if the review efficiency is too low, resulting in a delay in the time to market of products, it will also affect people's health and safety.
After all, disease waits for no one.
Taking drugs as an example, the backlog of drug registration applications in my country has been serious in the past period of time, with a backlog of 22,000 applications at most.
After many drug applications are registered, they wait years for approval.
Pharmaceutical companies are helpless, and patients are miserable.
How to speed up the review?
This is the first problem to be solved by the reform.
The drug regulatory department saw the move and launched a series of powerful measures——
Fully implement the 60-day implied license system for drug clinical trials, which is one-third shorter than the 90-day review time limit before the reform.
Establish and improve the drug registration procedures for accelerated listing, optimize the review and approval process, and prioritize the implementation of urgently needed drugs in short supply, anti-cancer drugs, pediatric drugs, drugs for rare diseases, drugs for major infectious diseases, vaccines urgently needed for disease prevention and control, and innovative high-end medical devices. review, greatly shortening the review time limit.
For drugs that show efficacy in early clinical trials, they can be approved for marketing with conditions, and they can be used early for urgently needed patients who cannot continue to wait.
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As a drug technical review agency, the Drug Evaluation Center of the State Food and Drug Administration also strengthens review project management, refines review sequences, strengthens time limit management, establishes special groups, increases reviewers, formulates and revises review points, and standardizes technical requirements The evaluation standards, quality and efficiency of drugs have been greatly improved.
"From the peak in 2015, there was a backlog of more than 20,000 applications, and since 2018, more than 90% of them have been reviewed on time, and my country's drug review and approval has entered the fast lane." The relevant person in charge of the Drug Registration Department of the State Food and Drug Administration told reporters, such as In terms of clinically urgently needed overseas marketed new drugs, by the end of 2021, 51 clinically urgently needed overseas new drugs have been approved for marketing, among which the review of rare disease drugs should be completed within 3 months, and the review of other clinically urgently needed drugs should be completed within 6 months. It has greatly shortened the time for new clinically needed overseas new drugs to be marketed in my country.
2. The enthusiasm for innovation in the pharmaceutical industry has been stimulated
The problem of the backlog of applications was resolved, and the drug launch speed was accelerated.
However, in order to meet the people's drug needs, it is still necessary to continue to have new drugs on the market.
Encouraging drug innovation is the core of review reform.
The "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices" issued in 2015 raised the standards for drug approval, and adjusted new drugs from "drugs that have not been marketed in China" to "drugs that have not been marketed in China or abroad". , which is "Global New".
Two years later, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Drug and Medical Device Innovation", making special arrangements for drug and medical device innovation.
The reporter learned that in order to encourage the research and development of innovative drugs and medical devices, the State Food and Drug Administration not only provides support in priority review and other aspects, but also formulates a series of "Technical Requirements for Pharmaceutical Common Issues in Application for Phase I Clinical Trials of Innovative Chemical Drugs", etc. Technical guiding principles to guide the R&D declaration of innovative products.
The reviewers will also take the initiative to communicate with the R&D and production parties in key review links such as pre-clinical, clinical, and pre-market applications to avoid detours.
"The review reform encourages clinical value-oriented drug innovation, optimizes the review and approval procedures for innovative drugs, and speeds up the review of innovative drugs that are urgently needed in clinical practice, which has greatly stimulated the R&D vitality of pharmaceutical companies." Renfu Pharmaceutical Group Co., Ltd. The person in charge told reporters that in recent years, the company has had a number of new drugs approved for the market, and its innovation capability has achieved new breakthroughs.
Among the many reform measures, the drug marketing authorization holder system deserves attention.
Previously, only drug manufacturers could apply for drug registration.
To register drugs, scientific researchers and scientific research institutions must first invest in the establishment of factories.
This management system that bundles product registration and production license is not conducive to drug innovation.
In 2015, my country launched a pilot drug marketing authorization holder system in 10 provinces and cities, and drug R&D institutions and scientific researchers can apply for registration of drugs.
Expert analysis pointed out that this move reduces the capital investment and time cost of drug developers, and new drugs can be launched three to five years earlier.
In 2019, the drug marketing authorization holder system was written into the newly revised Drug Administration Law and fully implemented nationwide.
According to the State Food and Drug Administration, in recent years, my country has made great progress in the development of innovative drugs.
From 2018 to 2021, the number of innovative drugs approved for listing has increased year by year, with 11, 12, 20, and 45, respectively, including new coronavirus vaccines and clinically urgently needed therapeutic drugs in the fields of tumors, immune system diseases, and rare diseases.
The pace of medical device innovation is also accelerating. In 2021, 35 innovative medical devices have been approved for the market, which is the year with the largest number of innovative products approved in recent years.
3. Consistency evaluation to improve the efficacy of generic drugs
In recent years, many previously expensive drugs have begun to drop in price.
A closer look reveals that there is a "hero" behind the drop in drug prices - generic drugs.
Innovative drugs provide new options for treating diseases and saving lives, but for the vast majority of patients, generic drugs are their lifeline.
According to the State Food and Drug Administration, my country's modern pharmaceutical industry started relatively late, and the production of drugs is dominated by imitations. More than 95% of the approved chemical drugs are generic drugs.
Generic drugs are imitations of the original drugs after the patent protection period expires, and the price is much lower than the original drugs.
In the past, the review and approval standards for generic drugs in my country were not high, and there was a lack of high-quality generic drugs. The efficacy was very different from the original drugs.
Improving the quality and efficacy of generic drugs is an important goal of the review reform, and the solution is to evaluate the consistency of the quality and efficacy of generic drugs. The core is that generic drugs need to reach the same level as the original brand drugs in terms of quality and efficacy, and can replace the original brand drugs in clinical practice.
"There are several key issues in carrying out the consistency evaluation. One is the selection and determination of reference preparations, the second is the determination of technical standards, and the third is to strictly follow the procedures." The relevant person in charge of the State Food and Drug Administration introduced that the bureau passed the improvement of The review system, strict evaluation standards, strengthening of service guidance, and optimization of work processes ensure the smooth development of the consistency evaluation of generic drugs.
At present, 4,677 specifications of the generic drug reference preparation catalog have been published, and 437 varieties of 2,044 specifications have been applied for through consistency evaluation.
Consistency evaluation puts generic drugs on the right track, and ultimately benefits the common people.
Since 2019, the pilot program of centralized procurement and use of drugs organized by the state was launched nationwide, and a number of domestic generic drugs have won bids.
Medical insurance, health care and other departments have organized medical institutions to conduct research on 14 representative generic drugs that have won the bid, and confirmed that these 14 generic drugs that have passed the consistency evaluation are clinically equivalent to the original research drugs.
Generic drugs with the same efficacy as the original research drug are not only cheaper, but also further reduce the price of the original research drug under the pressure of competition, greatly reducing the drug burden on patients.
4. Emergency review and approval provide a strong guarantee for epidemic prevention and control
4 days, which is the time for my country to complete the review and approval of the world's first new coronavirus nucleic acid detection reagents and sequencing reagents.
On January 20, 2020, the Device Center of the State Food and Drug Administration started the emergency work overnight, and the reviewers worked through the night to connect with the enterprises one by one, and the review and R&D were carried out simultaneously.
On January 26, the first batch of 4 in vitro diagnostic reagent products were approved for the market, providing an effective detection method for the front line of anti-epidemic.
The outbreak of the new crown pneumonia epidemic has challenged the review reform.
Xu Jinghe, deputy director of the State Food and Drug Administration, said at the Boao Forum for Asia in 2021 that the role of the drug regulatory department in epidemic prevention and control has changed, from reviewers to instructors, working with enterprises to speed up product launch.
It is understood that the State Food and Drug Administration has made every effort to carry out emergency review and approval work during the epidemic.
Five new coronavirus vaccines have been approved for listing with conditions, two new coronavirus vaccines have been approved for emergency use, and 34 vaccine varieties with five technical routes have entered clinical trials.
The organization formulated 3 technical guidelines for the research and development of new coronavirus therapeutic drugs, approved 58 clinical trials of new coronavirus therapeutic drugs, and approved the registration and marketing of Qingfei Paidu granules, Huashi Baidu granules, and Xuanfei Baidu granules.
106 new coronavirus detection reagents were approved to effectively meet the needs of epidemic prevention and control.
The epidemic is not over yet, and the emergency review and approval is still going on.
As long as people's health needs it, the review reform will not stop.
The drug regulatory authorities and reviewers have been accelerating their efforts to achieve a healthy China, accelerating the pace of people's health.
(Reporter Chen Haibo of this newspaper)