Medical network - on December 9, 2016, China's pharmaceutical industry very lively, the state council, the state development planning commission, the state food and drug supervision and administration of administration departments have promulgated several policies and regulations, conformity assessment, clinical data inspection and process inspection strictly the quality pass, to accelerate the industry evolution; Urban and rural system and medical insurance directory of readjustment process; "everyone enjoys health" era Circulation verification a strong start, landscape accelerated reshaping. Under the impetus of the health care policy reform, the development of pharmaceutical industry in China are moving in the specification of the fast lane! 2016 blockbuster drug policy, sina medical news for your inventory as follows: (click on the title, access to the original policy)
1, the CFDA issued "about suspended 2015 announcement of announcement no. 1 to the relevant provisions of the drug electronic monitoring (40, 2016)"
On February 20th, the state food and drug supervision and administration bureau released on the suspended 2015 announcement of announcement no. 1 to the relevant provisions of the drug electronic monitoring (40, 2016), decided to suspend the relevant provisions of the drug electronic monitoring, ado drug electronic regulatory dispute over for many years. On June 30, the state food and drug supervision and management of the administration, adopted at the meeting examined and approved on the modified < drug management quality management > decision ", modify the content of the circulation of medicines and pharmaceutical trading enterprises how to implement drug traceability system operational requirements are put forward.
Micro policy review: without the electronic supervision code, after tracing system how to build? In the CFDA issued a draft amendment to the GSP, adjust drug electronic monitoring system for drug tracing system, emphasizing on pharmaceutical production, management enterprise, the main responsibility for establish the traceability system, implementation can check drug source, go back, responsibility to investigate. At the same time, the enterprise shall set up to meet the requirements of the business process management and quality control computer system, realize the drug quality traceability. So at this stage no drug safety code, after tracing system construction, is not is a particularly challenging problem.
2, the state council issued the development strategy of traditional Chinese medicine outline (2016-2030)"
On February 26, the state council issued the development strategy of Chinese medicine outline (2016-2030), has been clear about the future 15 years development direction and focus of Chinese medicine in our country, is promoting the development of the cause of Chinese medicine in our country in the new period the programmatic document. At the same time put forward by the year 2020, everyone enjoys the basic services of traditional Chinese medicine, Chinese medicine industry become one of the important pillar of the national economy; By 2030, complete coverage of services implementation of traditional Chinese medicine, Chinese medicine will markedly enhance its capability of health service, make greater contributions to the economic and social development. On December 6, the state council issued a white paper on China's traditional Chinese medicine, again for Chinese medicine attaches great importance to the business.
Micro policy review: the "program" is the first time at the national level of TCM development planning, marks the development of traditional Chinese medicine has been listed in the national development strategy. Chinese medicine is the quintessence of our country, and Chinese medicine as a unique health resources in our country has strong economic, ecological and cultural advantage. Form of aging in China, traditional Chinese medicine health service demand growing situation urgently need us to strengthen the inheritance and innovation of traditional Chinese medicine.
3, the state council issued the implementation of generics consistency quality and curative effect evaluation of opinion"
On March 5, the state council formally issued the implementation of generics's opinions on quality and curative effect evaluation consistency, require chemicals new registered classification (March 4) approved prior to implementation of generics, who is not in accordance with the principle of in line with the original drug quality and curative effect of examination and approval, shall be in consistency. In the national list of essential medicines (2012 edition) on October 1, 2007 approved chemicals generics (289), oral solid preparations should be completed by the end of 2018 the consistency evaluation, which need to carry out clinical effectiveness test and the variety of special circumstances, should be completed by the end of 2021 the consistency evaluation; Fails to complete, and shall not be registered.
Micro policy review: as early as 2012 promulgated by the state council in the "national drug safety" twelfth five-year "plan" has consistency evaluation is put forward to improve the quality of generic drugs, generic quality consistency and curative effect evaluation work, to improve the overall level of the pharmaceutical industry in our country, to ensure drug safety and effectiveness, to promote the pharmaceutical industry upgrade and structural adjustment, strengthen the international competitive ability, has the very vital significance.
4, the state council issued the deepening medical and health system reform in 2016 key task"
On April 26, the state council general office issued the deepening the reform of medical health system key tasks in 2016, explicitly reform pilot provinces to spread all over the whole range of two votes, to encourage a vote, hospital and pharmaceutical production enterprise of direct settlement payment for goods, drug companies and distribution enterprise computing distribution costs. This year added four reform pilot provinces (municipalities), the national health reform pilot provinces (municipalities) reached eight, namely, anhui, fujian, jiangsu, qinghai, shaanxi, Shanghai, zhejiang, sichuan province (city), etc. 100 new pilot cities, make the national pilot cities to about 200.
Micro policy review: at present, the reform of the medical institution, the center of gravity is to break out the mechanism of medicine for the medical. Tender compression product space on one hand, on the one hand, cancel the hospital drugs addition, damaged the interests of hospitals and doctors, timely launch of two votes, lead to the perfect the reform plan: reduces the drug prices, both at the same time maintain the benign operation of the hospital, also don't have to increase fiscal input, is fully staffed. Two votes in the field of pharmaceutical circulation promotion will accelerate industry reshuffle, distribution power company integrating annexation provincial agency business company will become the industry development trend.
5, the CFDA release an announcement in the medicine circulation field illegal business behavior
On May 3rd, the CFDA announcement to illegal drugs circulation management behavior to carry out the centralized control. Notice to require all pharmaceutical wholesale enterprises to carry out the inspection first, whether there is any suspicion of this enterprise affiliated, go comparing the problems of 10 aspects, such as inspection, corrective actions and plan, introspects and rectification report on May 31, 2016 submitted to the provincial food and drug regulatory authorities.
Micro policy review: circulation verification a strong start, landscape accelerated reshaping. Issued the announcement is to mend the early vaccine events reflects the circulation of the holes is also for the implementation of two votes across the country, the ultimate goal is to regulate drug management, improve the industry concentration, reduce circulation, reduce prices, promote medicine separation.
6, issued by the state council general office on the pharmaceutical marketing authorisation holder system pilot program"
On June 6, the state council issued the drug marketing authorisation holder system pilot programme, to drug marketing authorisation holder system pilot work deployment. In Beijing, tianjin, hebei, Shanghai, jiangsu, zhejiang, fujian, shandong, guangdong, sichuan and other 10 provinces (municipalities) to carry out the pilot work.
Micro policy review: to carry out the drug marketing authorisation holder system experiment is an important content of drug approval for examination and approval system reform, is advantageous to the drug research and development institutions and scientific research personnel actively development of new drugs, is advantageous to the industrial structure adjustment and optimal allocation of resources, promote the professional division of labor, improve industrial concentration, avoid duplication of investment and construction, to encourage drug innovation, improving the quality of drugs is of great significance.
7, people club department "about promoting instructional advice on the reform of medical treatment, health care, medical linkage"
On June 29 people club department issued by the "about promoting instructional advice on the reform of medical treatment, health care, medical linkage", put forward actively explore play a fundamental role in health care in health care, give play to the role of health care the external restriction to the medical service, promote the reform of mechanism of system of medical treatment, medicine. In terms of payment, "opinions" clearly pointed out that the outstanding position to put the payment reform in health care, payment play in regulating the behavior of medical service and control the medical expense unreasonable growth, strengthen and reform of public hospitals, price reform, such as the linkage, play a health insurance to pay for medical institutions and medical personnel role of incentive and constraint.
Micro policy review: "opinion" series of "discovery" of health care reform itself and with the relevant reform of "fit", almost offers an interpretation as much as possible to the health care payer "essential role". Concerned personage thinks, develop scientific medicine pay for health care policy, is the key to solve the problem of drug prices, a lot of future, the long-awaited health care payment standards may be accelerated.
8, the CFDA inviting public "about the comments of the drug clinical trial data verification issues related to the announcement (draft)"
On August 24, the CFDA inviting public "about the comments of the drug clinical trial data verification issues related to the announcement (draft)", the main punishment including: shall be investigated for the applicant, the clinical test units, contract research organization of the responsibility; Gross clinical trials in fraud shall not apply for 1 year; Fraud is in clinical trials has approved three years not to accept the application; Inspection report will be linked to an application for registration. In July 2015, the CFDA issued "about a drug clinical trial data comprehensive inspections of announcement, asked to report has the manufacture or import drug application for registration of the pending drug clinical trial is to carry out the check list, as of 1 January 2016 to withdraw and not through a combined 1151, almost three-quarters of total check list for verification.
Micro policy review: our country is the generic drug production power, pharmaceutical industry after 30 years of rapid development, to meet people's basic medical drug accessibility at the same time, also associated with serious product homogeneity, excess production capacity, research and development problems such as lack of innovation. Especially in new drug research and development foundation is weak, experienced a disorderly, overheating stage, a large number of "new drug" application for registration in a market driven by the interests of the flock to register for examination and approval department. For clinical data is incomplete or fraudulent companies, relevant personage thinks, the enterprise actively withdrawn is smart, complete relevant materials and submit it again, also can avoid being punished.
9, people club department about the "2016 national basic medical insurance, inductrial injury insurance and maternity insurance drug catalogue adjustment work plan (draft)"
Released on September 30, people club department issued the "on" 2016 national basic medical insurance, inductrial injury insurance and maternity insurance drug catalogue work adjustment plan (draft) > public advice notice, the drug directory is divided into the drug bring up the call and medicines, transferred to consider high clinical value in the new drug, local drug b adjustment to increase more drugs as well as the major disease treatment, medicine, occupational medicine for children, urgent rescue special medicine, etc.; Directory of the original drug, such as has been the national drug regulatory department is prohibited to produce, sell and use, should be bring up the directory; There are other do not conform to the requirements of the medical insurance drugs and conditions, the corresponding review program can be paged out directory.
Micro policy review: it is seven years since 2009, the national start again the adjustment of medical insurance directory. The personage inside course of study points out that the adjustment of the medical insurance directory, will be on drug market layout and marketing interests rearrangement.
10, people club department: from 2017, our country will begin to establish a unified urban and rural residents health care system
On October 9, people club department issued a notice, put forward to promote basic health care integration between urban and rural areas, efforts to achieve by the end of all provinces, autonomous regions and municipalities directly under the integration plan, in 2017 began to establish a unified urban and rural residents health care system. In January, the state council issued "on the opinions of the integration of urban and rural residents basic medical insurance system, stressed that the integration of urban and rural residents health care system is a priority task of deepening reform, the provinces (autonomous regions and municipalities) in 2016 to the end of June to system integration planning and deployment, each region as a whole to a concrete implementation plan prior to the end of December 2016. At present, tianjin, Shanghai, zhejiang, shandong, guangdong, chongqing, ningxia, qinghai, xinjiang production and construction corps in 9 provinces (autonomous regions and municipalities) have been fully realize the integration of the joining together of two insurance work; Hebei, hubei, Inner Mongolia, guangxi, jiangxi, xinjiang, Beijing 8 provinces (autonomous regions and municipalities) has issued integration scheme.
Micro policy review: urban and rural health care integration of medical insurance system in China will from the original "3 + 1", that is, from the worker health, residents' health care and new farming + medical aid into "2 + 1", worker health, urban and rural residents health care + medical relief, the system construction will be improved. For ordinary people, after the integration can be implemented both in urban and rural areas, both farmers and the identity of the city, people enjoy a system, a kind of policy, this is beneficial to equal civil rights, also is advantageous to the equalization of public services, to further promote the social equity and justice.
11, the state council issued the "healthy China 2030" planning outline
, according to xinhua news agency on October 25, the party central committee and the state council recently issued the "healthy China 2030" planning outline, and issued a circular, urged all localities departments combined with real earnest implementation. "The plan" put forward: by 2030, the main health indicators in high-income countries, life expectancy is currently adding about 3 years old to 79 years old, health science and technology innovation such as the overall strength among the world top strategic objectives.
Micro policy review: the health program for China's 2030 will "healthy China" strategy to unprecedented heights, as is so intertwined with the biological pharmaceutical industry, in the new times will no doubt bring up more opportunities, the emergence of more structured opportunity.
12, ministry of industry and so on six departments jointly issued by the pharmaceutical industry development planning guide"
On November 7, the ministry, national health development planning commission and so on six departments jointly issued by the pharmaceutical industry development planning guide, pharmaceutical industry how to improve the level of internationalization development, encourage new drugs, chemical generic drugs, Chinese medicine, biological medicine similar international registration, achieve 3-5 new drugs and more than 200 chemical generics market in developed countries.
Micro policy review: as "much starker choices-and graver consequences-in" guiding the development of the pharmaceutical industry special planning guide, the guide is made clear the deficiency existing in the present our country medicine industry with difficulty, also indicate the necessity for the pharmaceutical industry from large to strong, for the future development of Chinese pharmaceutical industry, undoubtedly have an indicator of explanatory significance. |
