A few days ago, the General Office of the CPC Central Committee and the General Office of the State Council issued the "Opinions on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices" (hereinafter referred to as the "Opinions"). The "Opinions" is of great significance for promoting China's drug innovation and comprehensively integrating with the international community. It will vigorously promote China's drug R&D and production to the international advanced level, and gradually realize the international sharing of evaluation, inspection, inspection standards and results.
The "Opinions" attaches great importance to the construction of clinical trial institutions. According to the relevant deployment, China will complete the consistency evaluation of 289 drugs by the end of 2018. At present, the evaluation varieties have entered the BE test (bioequivalence test) stage, and the domestic clinical trial resources are tight. The "Opinions" clarify the implementation of record management for the qualification of clinical trial institutions, which means that GCP certification will be abolished, encouraging social forces to invest in setting up clinical trial institutions. At the same time, it is encouraged to support medical institutions, medical research institutions, and medical colleges and universities to conduct clinical trials, to incorporate clinical trial conditions and ability evaluation into the evaluation of medical institutions, and to establish a separate evaluation and evaluation system. These measures are greatly beneficial to the release of clinical resources, and the clinical resources of the BE trial since the consistency evaluation has been expected to be alleviated.
Clinical trial approval will receive data from overseas clinical trials. The "Opinions" clarify that the clinical trial data obtained by domestic and foreign pharmaceutical companies in overseas multi-centers, in line with the relevant requirements for the registration of Chinese pharmaceutical medical devices, can be directly used to apply for registration in China. For pharmaceutical medical devices that are first applied for listing in China, the applicant for registration should provide clinical trial data on the existence of ethnic differences. This includes the BE test data of the applicant's approved generic drugs in Europe, the United States, and Japan, as well as the medical device clinical trial data submitted by the applicant when it is approved for overseas listing. It can be used as clinical trial data to declare medical device registration in China.
In the past two years, China has implemented a drug review and approval reform, and the speed of approval of new drugs has been greatly improved. The release of the "Opinions" will greatly promote the international mutual recognition of clinical data, greatly reduce the clinical trial cost of drug medical device research and development, shorten the examination and approval time, and help domestic patients to use the world's most advanced drugs and medical devices as soon as possible, and also be an innovative drug in China. And generics have opened the way to the world.
In addition, the "Opinions" allow overseas enterprises and scientific research institutions to simultaneously conduct new drug clinical trials in China, optimize clinical trial approval procedures (cancel clinical approvals), establish and improve communication mechanisms between registered applicants and review institutions, and support extended clinical trials. (Promoting cellular immunotherapy), serious investigations and other major measures such as data fraud, will greatly promote the healthy development of clinical research in China, paving the way for clinical trial results to be internationally recognized and shared.
The release of the "Opinions" can be described as a milestone in the history of the development of the Chinese pharmaceutical industry. In addition to the clinical trial reform, the Opinions also proposed the “conditional approval for listing†for the accelerated examination and approval of medical devices for urgently needed drugs and rare diseases. In order to promote the development of drug innovation and generic drugs, the “medical patent term†was proposed. "Compensation system for compensation" and "Improvement and implementation of drug test data protection system"; in line with the international DMF system, the examination and approval of the drug and medicinal raw materials and packaging materials will be carried out, and the approval number of the drug substance will not be issued; And carry out re-evaluation of drug injections, and so on. The implementation of these new policies will lead the Chinese pharmaceutical industry to a comprehensive level at the international level.
Promote the integration of Chinese pharmaceutical industry with the international
The innovative development of the pharmaceutical industry is inseparable from the internal drive of innovative main enterprises, and it is inseparable from the matching regulatory science and payment system. The programmatic documents such as the Opinions on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices (hereinafter referred to as the "Opinions") are published by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council. The intensity is unprecedented, not only for innovative enterprises. Encourage and have a positive impact on ensuring drug safety.
The 36 articles in the "Opinions" mainly focus on the two keywords of "innovation" and "quality". At present, China's ability to innovate, the quality of medicines, and the accessibility of medicines are inconsistent with the status of the world's second largest economy. The timely release of the "Opinions" will play a key role in promoting the integration of China's pharmaceutical industry with the international market.
There are many policy provisions in the Opinions that encourage innovation, echoing the industry's expectations for many years. For example, the protection policy for intellectual property rights, including the establishment of a drug patent link system, the pilot of the drug patent term compensation system, and the improvement and implementation of the drug test data protection system are all supporting policies for building a pharmaceutical innovation country.
The relevant departments proposed by the "Opinions" should coordinate and cooperate and form a joint force for reform, which is a highlight of the document. The innovation projects for medicines and medical devices are vast. The Opinions pointed out that the national food and drug supervision departments should take the lead role, do a good job in the implementation of reforms, and coordinate the implementation of tasks. The relevant departments, including the development and reform departments, the labor and credit departments, the science and technology departments, and the health and family planning departments, must work together to form a synergy. Compared with the previous policies, this is the first time that the roles and responsibilities of various ministries are clearly listed, which provides an important guarantee for the effective and orderly implementation of the follow-up policies.
It is worth mentioning that the "Opinions" proposed that innovative drugs should be included in the scope of basic medical insurance payment in a timely manner according to regulations. At the same time, it is also suggested that all localities can timely incorporate new drugs with clear curative effects and reasonable prices into the centralized procurement of drugs in public hospitals. If innovative drugs can be better and faster included in the scope of national medical insurance payments, high-quality innovative drug companies can obtain reasonable returns, and enterprise innovation has the power and strength to help the pharmaceutical industry form a virtuous circle and thus better promote Innovation and development. This is the premise for China to become a big country for innovative medicine. Innovative enterprises are waiting for it, and we hope to see more positive policies follow-up.
The policy of not covering capital markets in the Opinions is somewhat regrettable. If we can rely on the power of capital and base ourselves on independent innovation, it will be conducive to creating a new model for the development of Chinese pharmaceutical companies.
The environment for the research and development of new drugs in China, including policies, talents, capital, venture capital, and supervision, is constantly improving, and the prospects are bright. The concept of Chinese pharmaceuticals in the international market is also changing. However, the domestic biotechnology industrialization stage has not really come yet, and many technologies and products are still in the “green seedling†stage. In the next 5 to 10 years, this situation may not be fundamentally changed. However, the overall level of research and development of new drugs in China will definitely be greatly improved. Some R&D fields will change from “running†to “running†at the current stage. ", and then to "lead", this will be an inevitable process for the improvement of the research and development level of Chinese pharmaceutical companies.
Focusing on innovation, quality and reform
The General Office of the Central Committee of the Communist Party of China and the General Office of the State Council recently issued the "Opinions on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices" (hereinafter referred to as the "Opinions"). The "Opinions" vigorously promoted the reform of the drug regulatory system. The advanced nature and scientific nature of its reform ideas have greatly surpassed the trend of developed countries, fully embodying the strength and determination of the Party Central Committee and the State Council, and is a vivid practice of the central government to comprehensively deepen reforms. It is a milestone for the development of China's pharmaceutical industry. As a pharmaceutical innovation company, we are encouraged and fortunate to catch up with the best era of Chinese pharmaceutical innovation.
Encouraging innovation and protecting innovation and innovation are the first essentials of the “Five Development Concepts†and the driving force for enterprises to cultivate core competitiveness. Throughout the full text of the Opinions, the core is to encourage and promote innovation, and boost the confidence of enterprises in the research and development of new drugs. In terms of clinical trials, the Opinions encourage medical institutions and social resources to join clinical research, and change the qualifications of clinical trial institutions to the filing system. What makes us more excited is the protection of the rights and interests of innovators. The "Opinions" not only clarified the exploration of the establishment of a patent link system, but also further improved the protection of drug test data, and carried out a trial of the drug patent term compensation system, which is actually an innovative drug. A set of combination boxing for intellectual property protection, through the construction of a systematic and scientific intellectual property protection mechanism, effectively protects the legitimate rights and interests of innovators and stimulates the motivation and vitality of innovators.
The implementation of the full life cycle management of the "Opinions" for the first time proposed the implementation of the full life cycle management in the development of pharmaceutical medical devices, the clear implementation of the legal liability of the holder of the listing permit, serious investigation and punishment of clinical trial data, so that all key aspects of drug development There are chapters to follow, and the "Ren Du Ermai" of new drug research and development has been opened up. At the same time, after the listing of drugs, medical institutions are encouraged to give priority to purchasing and using innovative drugs, to support innovative drugs to be included in the scope of basic medical insurance payments, to effectively promote the clinical application of innovative drugs, so that innovative drugs can benefit the people as soon as possible.
Accelerating the integration of medical innovation and international standards The Opinions clarify the content of data received from overseas clinical trials. The clinical trial data obtained by the applicants in overseas multi-centers, which meet the relevant requirements of China, can be used for registration applications in China. This has made it possible for Chinese patients to use the latest therapeutic drugs in the world as soon as possible, and paved the way for China's innovative drugs to go international.
The release of the "Opinions" not only points the way for our future development, but will further enhance the driving force for continuous innovation. Beida Pharmaceutical will surely rely on the national reform, based on the health needs of the people's livelihood, uphold the concept of "exploitation and innovation, benefit the people", earnestly shoulder the mission of revitalizing the national pharmaceutical industry, increase the research and development of new drugs, and develop more for the people. Affordable medicine can make greater contributions to the health of the Chinese nation.
China's pharmaceutical innovation ushers in the best era
During the "Thirteenth Five-Year Plan" period, China is transforming from a big pharmaceutical country to a strong pharmaceutical country. During the critical period of development of this industry, the General Office of the CPC Central Committee and the General Office of the State Council issued the "Research on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices. The Opinions (hereinafter referred to as the "Opinions") fully demonstrate that the party and the government attach great importance to medical innovation.
Each of the "Opinions" responds to the industry's many years of expectations, not only provides policy support for enterprises to carry out innovation, but also provides a guarantee for meeting the needs of patients.
As one of the participants in this ecosystem, pharmaceutical companies need to adjust their roles as soon as possible around the three major themes of reform, innovation and quality, and actively participate in the reform.
With the deepening of the reform, the "Opinions" are very concerned about "unmet medical needs". While safeguarding the safety of drugs, through reforms such as decentralization and decentralization, and speeding up examination and approval, we will focus on supporting new drugs that fill the clinical gap as soon as possible.
As the first responsible person of drug quality, the company is responsible for the research and development, production and after-sales service of drugs, as well as the full cycle of clinical use reports. This requires not only pharmaceutical companies to ensure the quality of drug production with a clearer sense of responsibility, but also further Intensifying innovation will have a foothold in the future pharmaceutical industry.
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