The 2017 season is approaching. Looking back at this unsettled year, the pharmaceutical industry has ushered in several major changes. The author has inquired through the database of pharmacological policies and regulations. As of December 22 this year, the competent national authorities and local competent authorities have successively issued more than 1,500 policies and administrative orders related to the medical and pharmaceutical industries.

The new policy was introduced and the direction of the baton was adjusted accordingly. In this article, we have compiled a heavy policy that has a greater impact before the ten projects, in order to get a glimpse of the recent dynamics and future trends in the pharmaceutical industry. The policy rankings are listed according to the release time, and the text sub-headings or important tasks are taken as a brief note, which is combined with the important significance of the policy and the significant impact that may occur. The original address of the top ten policies is attached for readers to read and download related documents.

NO. 1: Two-vote system officially promulgated and implemented

On January 9, 2017, the State Council Medical Reform Office and the State Health Planning Commission jointly issued the “Notice on Implementing the “Two-Ticket System” in the Drug Purchase of Public Medical Institutions (Trial)” and implemented it throughout the country. . This opinion clearly defines the "two-vote system" and stipulates the scope of implementation of the "two-vote system". It requires all localities, departments and public medical institutions to fully understand the important significance of implementing the "two-vote system" and strictly implement the drug purchase and sales bills. Management regulations, create conditions to support the implementation of the "two-vote system", effectively strengthen the supervision and inspection of the implementation of the "two-vote system" and strengthen policy publicity.

Comments: "Two-vote system" is a major measure to deepen the reform of the medical and health system and promote the healthy development of the pharmaceutical industry. It is an important starting point for regulating the order of drug circulation, compressing circulation links, and reducing the high and high drug prices. It is to purify the circulation environment and combat " It is an inevitable requirement to protect the safety of medicines used by urban and rural residents and safeguard the health of the people.

The two-vote system was officially promulgated and implemented, which brought a larger investment opportunity for new medical and economic investment, formed a favorable development environment for large-scale circulation enterprises and sales outsourcing organizations, and served as a comprehensive hospital with supply chain management as its main business and hospital as a customer. The industry is bound to rise.

NO. 2: Chinese medicine "One Belt, One Road" plan released

On January 16, 2017, the State Administration of Traditional Chinese Medicine and the National Development and Reform Commission jointly issued the "One Belt and One Road" Development Plan for Chinese Medicine (2016-2020), proposing that by 2020, the new pattern of all-round cooperation of Chinese medicine "Belt and Road" Basically, it will cooperate with countries along the route to build 30 Chinese medicine overseas centers, promulgate 20 international standards for Chinese medicine, register 100 kinds of Chinese medicine products, and build 50 demonstration bases for foreign exchange and cooperation of Chinese medicine.

Comments: The "One Belt, One Road" plan for Chinese medicine will inevitably establish a more comprehensive multilateral mechanism, promote the overseas registration of Chinese medicine products, promote the export of Chinese medicine culture, and bring unprecedented opportunities for Chinese medicine to go abroad.

NO. 3: The opinions on the reform of pharmaceutical production and circulation are released

On February 9, 2017, the General Office of the State Council promulgated the "Several Opinions on Further Reforming and Perfecting the Policy of Drug Production and Circulation Use", which puts forward reform opinions on the three links of drug production, circulation and use, involving drugs. Quality, consistency evaluation, drug listed holder system, medical insurance control fees, medical separation and other aspects are of great significance to promote the transformation and upgrading of the pharmaceutical industry.

Comments: The "Opinions" embodies the state's support for innovative drug research and development from the whole process and top-level design; starting from the whole chain of drug production, circulation and use, improving the drug production and use policy; starting from increasing the structural adjustment of the pharmaceutical industry, The withdrawal of outdated enterprises will guide pharmaceutical companies to develop in the middle and high-end, and solve the problems of large number, small scale and low level of pharmaceutical production enterprises; it is to promote the "two-vote system" of drug purchase and sales in the country to promote a strong guarantee.

NO. 4: The “13th Five-Year” National Drug Safety Plan is issued

On February 21, 2017, the "13th Five-Year National Drug Safety Plan" issued by the State Council pointed out that during the "13th Five-Year Plan" period, there are five major tasks in China's drug safety that will be completed: First, accelerate the imitation of imitation The consistency of pharmaceutical quality and efficacy evaluation; second, deepen the reform of drug medical device review and approval system; third, improve the regulatory standards system; fourth, strengthen the whole process supervision; fifth, comprehensively strengthen capacity building.

Comments: The "13th Five-Year National Drug Safety Plan" is the basic basis for the overall deployment of China's drug safety work in the next five years, an important indicator for building a healthy China, and the beginning of the improvement of drug quality and safety as determined by the Fifth Plenary Session of the 18th Central Committee. The work. Among them, the plan emphasizes the use of “Internet +”, big data, etc. to implement online smart supervision, strictly implement the safety responsibility of all aspects of drug production, operation, use, testing, supervision, etc., and bring a booming emerging market for the pharmaceutical industry.

NO. 5: 2017 new national drug catalog implementation

On February 21, 2017, the Ministry of Human Resources and Social Security issued the Notice on Printing and Distributing the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drugs Catalogue (2017 Edition). After eight years, the latest medical insurance catalogue was released again, and 36 Negotiated drugs are included in the scope of medical insurance payments. A total of 2,535 drugs were collected in Western medicine and Chinese patent medicines, an increase of 339 compared with the 2009 edition, an increase of about 15.4%, which has a far-reaching impact on the pharmaceutical market in China.

Comments: 2017 is the year of the medical insurance catalogue policy, the era of change, the strong and strong, the ability to win. The expansion of the new medical insurance catalogue reflects the steady growth of the pharmaceutical industry, and it also reminds us of the necessity of structural adjustment and strong implementation of control fees. Most of the key therapeutic varieties of key companies have entered the catalogue. This is not only the introduction of a medical insurance catalogue, but also a guiding sign for the pharmaceutical industry. It is the fuse of the pharmaceutical market, indicating the beginning of the spring of the pharmaceutical industry.

NO. 6: Generic drug consistency evaluation variety classification guidance

On April 5, 2017, the State Food and Drug Administration officially formulated the “Guiding Opinions on the Classification of Generic Quality and Efficacy Consistency Evaluation Varieties”. This opinion classifies the original imported and listed varieties, the original research enterprises in China to produce listed varieties, imported imitation varieties, domestic imitation varieties, change specifications, change dosage forms, change the base of imitation products and six varieties of endemic varieties, and six Large varieties have given specific guidance on the development of consistency evaluation work.

Comments: The release of "Opinions" means the landing of another important document of consistency evaluation. This will be a big reward for companies and products that have been declared in strict accordance with the principle of consistency. The consistency evaluation has entered a comprehensive development stage. The classification method has made a clear clearing of the previously chaotic and difficult situation, which makes the enterprise have a rule in the process of carrying out the consistency evaluation work. The enterprise is in the process of promoting this work. Many problems encountered are also being gradually solved.

NO. 7: State Council overhaul "Regulations on Medical Device Supervision and Administration"

On May 19, 2017, the State Council once again “modified” the management regulations, adjusted the approval of large-scale medical equipment from non-administrative licensing approval items to administrative licensing items, and further standardized and strengthened the management of the allocation and use of large-scale medical equipment. To ensure the quality and safety of medical care and promote the deployment of medical resources.

Comments: Strict examination and approval, and gradually realize legalization, standardization, and refinement. It is a management trend that has long been clearly defined in the management of large-scale medical equipment. The state has clearly stated that the configuration of large-scale medical equipment should conform to regional health planning and be compatible with the functional positioning of medical institutions. This regulation is an organic part of implementing China's deepening medical and health system reform medical control fee requirements and realizing the income structure of public hospitals. It is conducive to mobilizing and enhancing the enthusiasm of medical institutions to carry out their work, and helps to further rationalize supervision. The relationship between departments, medical institutions, and medical equipment companies.

NO. 8: The Chinese Medicine Law of the People's Republic of China is officially implemented

On July 1, 2017, the "Chinese Medicine Law of the People's Republic of China" was officially implemented. On December 25, 2016, the Standing Committee of the National People's Congress deliberated and approved China's first "Chinese Medicine Law", which clarified the important position and development policy of the Chinese medicine industry, and proposed to establish a management system that conforms to the characteristics of traditional Chinese medicine and increase the use of traditional Chinese medicine. Supporting the cause of the cause, insisting on equal emphasis on support and regulation, strengthening supervision over Chinese medicine, and increasing penalties for violations of Chinese medicine.

Comments: The "Traditional Chinese Medicine Law" raises the party's and the state's Chinese medicine guidelines and policies to the national will, and fixes the responsibility for developing Chinese medicine in the form of law, providing a solid guarantee for supporting and promoting the development of Chinese medicine. The "Traditional Chinese Medicine Law" will incorporate the development funds for the Chinese medicine industry into the financial budget, and open the door to medical insurance, which will vigorously promote the revitalization of the Chinese medicine industry. The Chinese Medicine Law changed the traditional Chinese medicine clinic from the current licensing management to filing management, changing the mode of managing Chinese medicine clinics by administrative examination and approval. Next, a large number of Chinese medicine clinics are expected to emerge. At the same time, it will also greatly increase the degree of marketization of the Chinese medicine industry.

NO. 9: Two papers to encourage innovation in pharmaceutical medical devices

On October 8, 2017, 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 Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices," from reforming clinical trial management, speeding up the approval of listing review, and promoting drug innovation. In the six aspects of the development of generic drugs, 36 specific measures were proposed to promote the structural adjustment and technological innovation of the pharmaceutical medical device industry.

Comments: At present, China's pharmaceutical medical device industry is developing rapidly, innovation and entrepreneurship are on the rise, and the reform of the review and approval system continues to advance. The Opinions regulates and stipulates a series of processes for the R&D and clinical trials of drugs and devices, and then registers and approves the listing, further encouraging innovation, especially clarifying that enterprises should play a corresponding role as the main body of innovation. This series of policy guidance is bound to bring about tremendous changes in the follow-up integration of pharmaceutical innovation companies and the competition pattern of generic drugs.

NO. 10: Imported drugs registered and listed

On October 10, 2017, the State Food and Drug Administration issued the "Decision on Adjusting the Relevant Matters Concerning the Registration and Administration of Imported Drugs." The "Decision" adjusted the scope of application of the relevant matters concerning the registration and management of imported drugs, including the application for international multi-central drug clinical trials in China, new drugs for chemical drugs, and clinical and import listing applications for the import of innovative biological drugs for therapeutic use.

Comments: This series of adjustments of "Decision" has relaxed the process of domestic registration approval for imported drugs, which means that multinational pharmaceutical companies can bring new drugs into the Chinese market earlier and benefit more patients, which will also encourage Chinese pharmaceutical companies to develop. Generic drugs are shifting toward the direction of developing new drugs.

Outlook

The pharmaceutical industry itself is an industry with obvious policy orientation and relatively solid structure. The series of reforms in 2017 will inevitably promote the growth of China's pharmaceutical market and bring about historic development opportunities in the pharmaceutical and medical industries . At the same time, this series of policies will also give full play to the top-level design. The leading advantage is to mobilize the resources of social resources to provide a supply of medical and medical services with rich levels, reasonable structure and high quality for our residents.

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