In the past ten years, some typical new drugs listed in China have been listed on the market for an average of 5-7 years later than Europe and the United States. It has been used for six or seven years abroad, and China has only listed. This is because many institutional designs have caused new drugs to be listed in China. . Because of this situation, there are more and more hidden diseases in the online purchase of drugs, including individuals carrying drugs from abroad.
Recently, one of the most important policies since the founding of the pharmaceutical industry was the "Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices" issued by the General Office of the CPC Central Committee and the General Office of the State Council (hereinafter referred to as "Opinions") Let the pharmaceutical industry boil.
Chinese new drugs are seriously lagging behind
When it comes to China's drug approval and listing system, it first appears in people's minds - "slow". Many new drugs are often blocked on the road to approval, and they are criticized by the industry.
As everyone knows, lack of medical care is a serious fact facing the Chinese people.
Wu Hao, deputy director of the State Food and Drug Administration, said at a press conference held recently that although we have made substantial reforms, there are still some problems. For example, some innovative drugs that are now required to be imported must be approved for listing in foreign countries before they can be applied for listing in China. For example, after the completion of the first phase of clinical trials in foreign countries, it is possible to apply for clinical trials in China. It is a late step, a slow half-shoot, and can not be synchronized. To some extent, some foreign innovative drugs are approved for listing in China.
The State Food and Drug Administration has made statistics. From 2001 to 2016, 433 new innovative drugs were approved for listing in developed countries, and only 100% were listed in China, accounting for only 30%.
In the past ten years, some typical new drugs listed in China have been listed on the market for an average of 5-7 years later than Europe and the United States. Foreign countries have used it for six or seven years, and China has only listed. This is because many institutional designs have caused new drugs in China. The listing is slow and half beat. Because this status quo exists, there are more and more hidden diseases in the online purchase of drugs, including individuals carrying drugs from abroad.
Earlier, some media reported that a new drug was imported in China for 6 to 10 months, the application review time was 20 months, and the slow time was 62 months. The total time lasted 5 years. Compared with the review time in Europe and the United States, the average US is 303 days, and Europe is about 1 year.
Heavy new drugs are expected to speed up listing
In recent years, the State Policy and the State Food and Drug Administration have continuously encouraged innovation, and have repeatedly issued policy dividends to speed up the process of new drugs from the laboratory to the clinic and then to the market.
In the past few years, the state has spent a lot of effort to reform the drug review and approval system. Since 2015, we have carried out a substantial reform of the review and approval system. In August 2015, the State Council issued a special document (No. 44), “Opinions on Reforming the Approval System for Drug Medical Device Evaluation and Approvalâ€, and made a series of reform system designs. At the same time, after the publication of the "Opinions", a series of matching reform measures were formulated. I can tell you today that the reform has achieved a phased effect.
Although these new policies may take some time to see the results, we have already seen some very exciting changes. The plight of the Chinese people's "difficulty in using drugs" is expected to become a thing of the past.
The "Opinions" issued by the "two offices" proposed to "accelerate the examination and approval of clinically urgently needed medical device evaluations", "encourage the development of new drugs and innovative medical devices, support national major science and technology projects and national key research and development programs, and national clinical medical research." The Center conducts clinical trials and new drugs and innovative medical devices approved by the central management department, giving priority review and approval.
At the same time, in the process of reviewing and approving new drugs, overseas clinical trial data can also be used to apply for registration.
Wu Hao pointed out that the key to solving the problem of public drug use is innovation. To get some new drugs listed as soon as possible, we say that not only domestic new drugs are listed, but also new drugs from abroad are listed in China as soon as possible.
According to reports, since the National Food and Drug Administration started reforms last year, the number of backlogs of clinical applications and registration applications has dropped from 22,000 to 8,000. Under high efficiency, we are welcoming the accelerated launch of many innovative drugs.
Wu Hao said that in the past two years, a number of new drugs and innovative medical devices have been approved for listing. The atmosphere of domestic pharmaceutical innovation has become increasingly strong. Some overseas medical and scientific researchers have returned to China to innovate more and more, and the investment in enterprise R&D has increased significantly, which has greatly stimulated the vitality of pharmaceutical medical device innovation.
Zhifei Biology announced in the evening that the “15-valent pneumococcal conjugate vaccine†of its wholly-owned subsidiary Beijing Zhifei Green Bamboo Bio-Pharmaceutical Co., Ltd. obtained the drug clinical trial approval from the State Food and Drug Administration, and agreed to use the product as a preventive organism. The product is clinically tested. The company stated that it will carry out relevant clinical trial work as soon as possible according to the requirements of clinical trial approvals.
As of the first half of 2017, Fosun Pharma has 6 monoclonal antibody varieties approved in China, 2 of which have entered the clinical phase III, and 4 1.1 small molecule innovative drugs have obtained clinical approval. 173 projects including new drugs, generic drugs, biosimilar drugs and vaccines.
Analysts in the pharmaceutical industry told Cypress that the "Opinions" will further stimulate the enthusiasm of drug companies for research and development of new drugs. Among them, measures such as speeding up the approval of listing review, promoting drug innovation and the development of generic drugs will bring direct benefits to companies with strong innovation and R&D capabilities, and companies with new drug reserves will also benefit from this policy.
In the past, Saibailan was also informed during the communication process with a number of multinational pharmaceutical companies. The recent fast-track review and approval of the regulatory authorities also prompted them to quickly adjust their new drug introduction programs in China and began to seek in China. The right business partner.
There is no doubt that the Chinese pharmaceutical industry is welcoming the spring of innovation. A vibrant and innovative environment is taking shape. Returning to the product-oriented competition in the pharmaceutical industry will also profoundly affect the circulation, sales and use of the industrial chain. .
For every medical person, this is the best time and a rare opportunity to seek development.
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