2016 my country's pharmaceutical industry is so lively，State Council、National Health and Family Planning Commission、The State Food and Drug Administration and other departments have promulgated multiple policies and regulations，Consistency Evaluation、Clinical data self -examination and craft verification strictly control the quality，Accelerating the industry's survival of the fittest; re -adjustment of urban and rural areas and medical insurance directory & ldquo; everyone enjoys medical insurance & rdquo;，Industry pattern accelerated reshaping。Driven by the reform of the medical policy，The development of my country's pharmaceutical industry is entering a standard fast track! 2016 heavy pharmaceutical policy，Sina Pharmaceutical News takes a look at the following: (click the question，Get the original text of the policy)

 

  1、CFDA issued "Announcement on the suspension of the implementation of the relevant provisions of the relevant regulations of the Pharmaceutical Electronics Supervision (No. 40)"

 

  February 20，The State Food and Drug Administration issued the "Announcement on the suspension of the implementation of the relevant regulations on the implementation of the announcement of the Pharmaceutical Electronic Supervision (2016 No. 40)"，Decision to suspend the relevant regulations of the implementation of drug electronic supervision，Disposal disputes that have been disturbed for many years come to an end。June 30，The State Food and Drug Administration Bureau of the State Administration of Food and Drug Administration reviewed and approved the "Decision on Modifying & LT; Drug Business Quality Management & GT;，Modify the content of the pharmaceutical circulation link of how Chinese medicine business enterprises implement the pharmaceutical traceability system。

 

  Policy micro -review: Without electronic supervision code，13452_13479，Adjust the drug electronic supervision system into a drug traceability system，Emphasize the production of drugs、Business enterprise is responsible subject，Establishing a drug traceability system，Realize the source of medicines can be checked、Go to the whereabouts、Responsibility for investigation。At the same time，Enterprises shall establish a computer system that can meet the requirements of the entire process management and quality control requirements，Realize the quality of drugs to traceable。So there is no drug supervision code at this stage，The construction of the traceability system after the following，Not a particularly challenging problem。

 

  2、The State Council issued the "Outline of the Strategic Planning of Traditional Chinese Medicine Development (2016-2030)"

 

  February 26，The State Council issued the "Outline of the Strategic Planning of Traditional Chinese Medicine Development (2016-2030)"，Clarified the development direction and work focus of Chinese medicine in my country in the next 15 years，It is a programmatic document that promotes the development of Chinese medicine in the new period。At the same time, it is proposed to 2020，Realize everyone who basically enjoys Chinese medicine services，The Chinese medicine industry will become one of the important pillars of the national economy; by 2030，A full coverage of the field of Chinese medicine services，Traditional Chinese medicine health service Stake Sports Bettingcapabilities stake betting apphave significantly enhanced，Make greater contributions to economic and social development。December 6，The State Council published "Chinese Medicine in China" White Paper，once again point out that the state attaches great importance to the cause of Chinese medicine。

 

  Policy micro -review: This "Planning Outline" is the first time to prepare the development plan of Chinese medicine at the national level，It marks that the development of Chinese medicine has been included in the national development strategy。Chinese medicine is the national essence of my country，and Chinese medicine as a unique health resources in my country has a strong economy、Ecological and cultural advantages。Chinese aging forms intensify，The increasing status quo of the needs of Chinese medicine health services urgently requires us to strengthen the inheritance and innovation of Chinese medicine。

 

  3、The State Council issued the "Opinions on the Evaluation of Consistent Evaluation of the Quality and Consistent Effective Effects"

 

  March 5，The State Council officially issued the "Opinions on the Evaluation of the Consistent Evaluation of the Quality and Consistent Effects"，Requirement of new registered and classification of chemicals (before March 4) approved the imitation drugs for listing，Approval for not in accordance with the principle of consistency in the principle of the quality and efficacy of the original drug，All consistency evaluations must be carried out。National Basic Pharmaceutical Catalog (2012 Edition) The chemical drugs of chemical drugs (289 in total)，The consistency evaluation should be completed by the end of 2018，Among them, a variety of clinical validity tests and special circumstances，The consistency evaluation should be completed by the end of 2021; if the overdue is not completed，Never registered。

 

  Policy micro -evaluation: As early as the "National Drug Safety & Ldquo; Twelve Five -Year Plan" issued by the State Council in 2012, it has been proposed in consistency evaluation to improve the quality of generic drugs，Carry out the consistency evaluation of the quality and efficacy of generic drugs，To improve the overall level of my country's pharmaceutical industry，Guarantee drug safety and effectiveness，Promoting the upgrade of the pharmaceutical industry and structural adjustment，Enhance international competitiveness，All of them are very important。

 

  4、The State Council issued "Deepening the Reform of the Medical and Health System Reform 2016 Key Work Task"

 

  April 26，The General Office of the State Council issued "Deepen the Reform of the Medical and Health System Reform 2016 Key Work Task"，Clarifying the provinces of medical reform must promote two votes in full range，Encourage one vote，Direct settlement of hospitals and pharmaceutical manufacturers，Pharmaceutical companies and distribution companies calculate the delivery fee。Four new medical reform pilot provinces (cities) this year，Make the national medical reform pilot province (city) reached 8，Anhui、Fujian、Jiangsu、Qinghai、Shaanxi Province、Shanghai、Zhejiang Province、Sichuan Province (city), etc.。Added 100 pilot cities，Makes 200 pilot cities across the country。

 

  Policy micro -review: Current，Reform of medical institutions，The center of gravity is to break away from the mechanism of drug care for medicine。On the one hand, bidding compressed products space，On the one hand, cancel hospital drug bonus，When the interests of hospitals and doctors are damaged，Two -vote system in time，This reform plan is perfect: both reduce the price of drugs，At the same time, the healthy operation of the hospital is maintained，No need to increase financial investment，Can be described as more in one fell swoop。The promotion of the two -vote system in the field of medical circulation will accelerate the reshuffle of the industry，Companies with strong distribution power to annex the provincial agency commercial company will become the development trend of the industry。

 

  5、CFDA issued an announcement on illegal business behavior in the field of drug circulation

 

  May 3，CFDA issued an announcement requires that local governments carry out centralized rectification of illegal operations in the field of drug circulation。Announcement stake online sports bettingrequires stake online sports bettingall drug wholesale enterprises to conduct self -examination first，Is there a suspected affiliation with the company?、Tickets and other aspects of 10 questions for comparison checks，Formulate rectification measures and plans，The self -examination and rectification report will be submitted to the provincial food and drug regulatory authorities before May 31, 2016。

 

  Policy micro -review: Startup inspection strong start，Industry pattern accelerated reshaping。The introduction of this announcement is to repair the loopholes refracted by the pre -vaccine incident.，The ultimate purpose is to regulate drug management，Improve industry concentration，Reduce circulation link，Reduce the price of medicine，Promoting medical separation。

 

  6、The General Office of the State Council on Printing and Distributing the Pilot Plan for the Pharmaceutical License Ownership System

 

  June 6，The State Council issued the "Pilot Plan for the Pharmaceutical Located Permit held by the drug"，Deployment of the pilot work of the holder system of drug listing permits。In Beijing、Tianjin、Hebei、Shanghai、Jiangsu、Zhejiang、Fujian、Shandong、Guangdong、Sichuan and other 10 provinces (cities) to carry out pilot work。

 

  Policy micro -evaluation: The pilot pilot of the Pharmaceutical Listing of Pharmaceutical Located is an important part of the reform of the drug review and approval system，It is conducive to the active creation of new drugs for drug research and development institutions and researchers，It is conducive to industrial structure adjustment and resource optimization allocation，Promote professional division of labor，Improve industrial concentration，Avoid repeated investment and construction，For encouragement of drug innovation、It is important to improve the quality of drugs。

 

  7、The Ministry of Human Resources and Social Security "Regarding active promotion of medical treatment、Medical Insurance、Guidance Opinions of the Reform of Medicine Links "

 

  June 29，The Ministry of Human Resources and Social Affairs issued "Actively Promoting Medical、Medical Insurance、Guidance Opinions of the Reform of Medicine Links "，Proposal to actively explore the basic role of medical insurance in medical reform，Give play to the external restriction effect of medical insurance for medical services，Promoting medical treatment、Reform of the medical system and mechanism。In terms of medical insurance payment，"Opinions" clearly pointed out，The reform of the payment method should be put in the prominent position of the medical reform，Give full -time payment method in standardized medical service behavior、Active role in controlling unreasonable growth of medical expenses，Strengthen the reform of public hospitals、Price Reform and other parties linkage，Give play to the incentive and restraint of medical insurance payment on medical institutions and medical staff。

 

  Policy micro -reviews: "Opinions" a series of & ldquo; exploration & rdquo; and & ldquo; expressing & rdquo; expression，Almost as much as possible & ldquo; basic role & rdquo;。Relevant persons think，Develop a scientific medical insurance and drug payment policy，The key to solving many problems in the field of drug prices in the future，The long -awaited medical insurance payment standard may be accelerated。

 

  8、CFDA publicly solicited "Announcement on the Opinions on the Processing Opinions on the Relevant Issues (Consultation Draft)" Opinion

 

  August 24，CFDA publicly solicited "Announcement on the Opinions on the Processing Opinions on the Relevant Issues (Consultation Draft)"，The main punishment includes: the applicant、Clinical trial institution、The responsibility of the contract research organization; not applying for fraud within one year of fraud during the application of clinical trials; the application for clinical trial fraud will not be accepted within 3 years; the self -examination report will be linked to the registration application。July 2015，CFDA issued the "Announcement on the Checking of the Pharmaceutical Clinical Test Data Verification"，It is required to carry stake online sports bettingout self -examination for My stake betting appclinical trials of drug registration applications that have been declared or imported，As of January 2016, withdrawing and not passing a total of 1151，The total number of self -inspection inspections is nearly 3/4。

 

  Policy micro -review: my country is a major country of generic drug production，After 30 years of high -speed development，While satisfying the people's basic medical medication, while，It has also been accompanied by a serious homogeneity of the product、Excess capacity、Insufficient R & D and innovation capabilities。Especially my country's new drug research and development foundation is weak，I have experienced disorder、Overheating phase，A large number of & ldquo; new medicine & rdquo; Register application under market interests, pouring to the registration approval department。For companies that are incomplete or fraudulent in clinical data，Related persons think，It is a wise move to take the initiative to withdraw by the company，Supplement the relevant materials for complete，Submit again，It can also be avoided for punishment。

 

  9、The Ministry of Human Resources and Social Affairs on the "2016 National Basic Medical Insurance、Work Injury Insurance and Maternity Insurance Drug Directory Adjustment Work Plan (Draft for Opinions)

 

  September 30，The Ministry of Human Resources and Social Affairs released the "About & LT; 2016 National Basic Medical Insurance、Work Injury Insurance and Maternity Insurance Drug Directory Adjustment Work Plan (Draft for Solicitation) & GT;，The adjustment of this drug directory is divided into drugs and drugs.，Considering new drugs with high clinical value、Class B adjustment of local B and increase the treatment of major diseases for major diseases、Children's medication、Urgent rescue medicine、Special medicine for occupational diseases, etc.;，If the production has been banned by the national drug regulatory authorities、Sales and use，It should be transferred to the directory; there are other that does not meet the requirements and conditions of medical insurance medication，After the corresponding review process, you can be transferred out of the directory。

 

  Policy micro -review: This is the seven years since the adjustment of 2009，The country once again activated the adjustment of the medical insurance directory。Some people in the industry pointed out，Adjustment of the medical insurance directory，The benefit of the pharmaceutical market layout and marketing methods will be re -exclusive。

 

  10、Ministry of Human Resources and Social Affairs: my country will start a unified urban and rural residents' medical insurance system in 2017

 

  October 9，The Ministry of Human Resources and Social Affairs issued a notice，Proposal to accelerate the integration of basic medical insurance for urban and rural areas，Efforts to achieve all provinces (districts at the end of the year、City) Introduction of integration plans，Starting to establish a unified urban and rural resident medical insurance system in 2017。In January，The State Council issued the "Opinions on Integrated Urban and Rural Residents' Basic Medical Insurance System" emphasized，Integrated urban and rural residents' medical insurance system is a key task for deepening medical reform，Provincial provinces (district、City) Plan and deploy system integration by the end of June 2016，Each region should introduce a specific implementation plan before the end of December 2016。Current，Tianjin、Shanghai、Zhejiang、Shandong、Guangdong、Chongqing、Ningxia、Qinghai、Xinjiang Production and Construction Corps and 9 provinces (districts、City) The integration of the two guarantees has been fully realized; Hebei、Hubei、Inner Mongolia、Jiangxi、Xinjiang、Beijing、8 provinces of Guangxi (district、City) The integration plan has been introduced。

 

  Policy micro -review: After the integration of urban and rural medical insurance, my country's medical insurance system will be from the original & ldquo; 3+1 & rdquo;，is from employee medical insurance、Resident medical insurance and Xinnonghe+medical assistance integration to & ldquo; 2+1 & rdquo;，employee medical insurance、Urban and rural residents medical insurance+medical My stake betting appstake online sports bettingassistance，System construction is more complete。For the common people，After integration, it can be achieved regardless of urban and rural，The identity of the peasants and the city does not distinguish between farmers and the city，Enjoy a system，A policy，This is conducive to equalization of citizen rights，It is also conducive to the equalization of public services，further promoted social fairness and justice。

 

  11、The State Council issued "& ldquo; Healthy China 2030 & rdquo; Planning Outline"

 

  According to Xinhua News Agency, October 25th，Central Committee of the Communist Party of China、The State Council recently issued "& ldquo; Healthy China 2030 & rdquo; Planning Outline"，and issue a notification，Requires and regional departments to implement it carefully in accordance with the actual situation。"Planning Outline" proposed: by 2030，my country's main health indicators enter the ranks of high -income countries，Per capita life expectancy is about 3 years old to 79 years old，Health Science and Technology Innovation overall strength is at the forefront of the world and other strategic goals。

 

  Policy micro -review: "Health China 2030 Planning Outline" raised & ldquo; Healthy China & RDQUO;，As a biomedical industry related to this rest，In the new situation, it will undoubtedly create more opportunities，More structural opportunities emerged。

 

  12、The Ministry of Industry and Information Technology and other six departments jointly issued the "Guide to the Medical Industry Development Planning Guide"

 

  November 7，Ministry of Industry and Information Technology、The National Health and Family Planning Commission and other six departments jointly issued the "Guide to the Medical Industry Development Planning Guide"，Requires the medical industry to improve the international development level，Encourage new medicine、Chemical imitation drugs、Chinese medicine、International registration of biological similar drugs，Achieve 3-5 new drugs and more than 200 chemical generic drugs in developed countries。

 

  Policy micro -review: as a special planning guide for the development of the pharmaceutical industry as a period of 135 & rdquo;，The Guide clearly clarifies the deficiencies and difficulties of the current existence of the pharmaceutical industry in my country，It also indicates the road of the pharmaceutical industry from large to strong，For the future development of China's pharmaceutical industry，It undoubtedly has the meaning of the vane of the outline。