I. The drug supervision code is fully rolled out

 

January 4，The State Food and Drug Administration issued the "Announcement on the Comprehensive Implementation of Pharmaceutical Electronic Supervision of Drug Production and Management"，Indicates before December 31, 2015，Domestic drug preparation manufacturers、Imported drugs and pharmaceutical manufacturers must be included in China Pharmaceutical Electronic Supervision Network，Chinese Pharmaceutical Electronics Regulatory Code (hereinafter referred to as an exciting code)。The drug preparations produced after January 1, 2016 should be fully code。

 

my country has implemented drug electronic supervision work since 2006，Incorporate various drugs into electronic supervision in stages。This year，As an electronic supervision target year as the entire process of the entire variety of drugs，Views of the industry and society。issues such as platform operation rights and use rights have always been the focus of public opinion discussion。

 

2. Pharmaceutical collection is designed and introduced

 

February 2My stake betting app8，The General Office of the State Council issued the "Guiding Opinions on Improving the Public Hospital's Centralized Procurement Work"。June 19，The National Health and Family Planning Commission announced the "Notice on Implementing and Implementing the Guiding Opinions of the Public Hospital's Drug Concentrated Procurement Work"。No. 7 civilization clearly proposed the provincial (district、City) The centralized procurement direction of online drugs in the unit，Implement a platform、Liech up and down、Public transparency、Category purchase，Adopt recruitment enterprises、Recruitment one、Loss and price linked、Dual envelope system、Monitoring and other measures in the whole process。In addition，It also proposed to purchase pilot cities、Sunshine Purchase and other content，and strengthened the regulatory requirements of distribution and repayment。No. 70 further refined the drug classification procurement measures，and bid for dual envelope、Drug settlement、Drug distribution、Construction of the Procurement Platform、Pilot city guidance, supervision and management and other content put forward specific requirements。

 

This is the well -known Circular 7 and No. 70，Two articles are immediately attracted close attention in the industry，Various interpretations are also endless，The meaning of this article will not be repeated here。Under this framework，The 2015 pharmaceutical collection and mining plan of all places was introduced，It can be seen from these schemes，Category purchases gradually become the core of drug recruitment work。

 

3. Drug price government pricing cancellation

 

May 4、The National Development and Reform Commission issued the "Notice on Printing and Distributing the Opinions on Promoting Drug Price Reform"，Requires from June 1, 2015，Except for anesthesia drugs and first type of psychiatric drugs，Cancel the price of drugs formulated by the original government。Anesthesia、The first category of psychotropic drugs is still temporarily implemented by the National Development and Reform Commission to implement the maximum ex -factory price and the highest retail price management。

 

The highest retail price limit policy with 15 years of history is officially entered into history，It marks an important step forward in my country's medical reform。At present, the more common point of view is believed，Drug price liberalization is just the first step in medical reform，How to truly benefit Yumin also needs supporting design and final implementation。It is worth mentioning that letting go of the price of drug prices is forcing the regulatory agency to improve the regulatory ability。

 

Four, the reform of the public hospital's reform

 

Stake Sports BettingMay My stake betting app8，The General Office of the State Council issued the "Implementation Opinions on the Comprehensive Reform of the County -level Public Hospital"。17th，The General Office of the State Council once again issued the "Guiding Opinions on the Pilot on Comprehensive Reform of Urban Public Hospitals"。Two documents are based on the target of eliminating the mechanism of drug -care and public hospitals.，From the hospital system、Operating mechanism、Medical Insurance Pay、Personnel salary、Hierarchical diagnosis and treatment、Social medical treatment and other aspects of the reform opinion，Consolidate and expand the effectiveness of reform。

 

Two public hospital reform documents cover the content very comprehensive，The reform content includes the core of the most important pharmaceutical care and profit -seeking mechanism，It also includes a collaborative development system such as hierarchical diagnosis and treatment and social medical treatment。Current，The most obvious industry experience must be the decline in drug prices。But the reform of the public hospital is led by the whole body，Facing huge difficulties in reform，The implementation of these two opinions will still wait and see。

 

5、& ldquo;

 

June 15，The General Office of the State Council issued the "Several Policies and Measures on Promoting Social Medicine Accelerating Development"，This article is further relaxed from access、Greed the investment and financing channels、Promoting resource flow and sharing、Optimized development environment and other aspects，I have proposed as detailed policy measures as possible，Encourage localized exploration。

 

Always，Social medical medicine & ldquo; Entering difficult & rdquo; The problem is in sharp comparison with the state's attitude of encouraging the social medical treatment。The strong plus the institutional mechanism barrier from the public hospital hinders the development of social medical treatment。This document shows the problem of admission to the social medical treatment，Relevant administrative departments at all levels are required to enter the principle of & rdquo;，Improve the establishment of approval management of social medical institutions。But relaxing social medical treatment is only the first step in development，Social medical treatment also needs to face talent introduction、Funds support、A series of challenges such as scale control and development environment，Unexpected policy supporting and landing。

 

6. Self -examination of clinical trial data

 

July 22，The State Food and Drug Administration issued the "Announcement of the State Administration of Food and Drug Administration on the Checkpiece of Pharmaceutical Clinical Experimental Data" decided to decide on the application of drug clinical experimental data verification for drug registration applications for production or imported drug registration，and said that the active withdrawal of the problem registration application can be exempted from punishment。

 

Since its release，The announcement was nicknamed & ldquo; 7.22 tragedy & rdquo;。After the State Food and Drug Administration, the State Food and Drug Administration has been promoting clinical trial data self -examination inspection，Announcement of self -inspection multiple times。The latest announcement released on December 8th，More than one -third of，A total of 596 varieties actively withdraw from drug registration application。In addition，There are 23 drug registrations to be withdrawn，9 clinical trial institutions have been filed for investigation。

 

7. Accelerate the accumulation of drug registration applications

 

July 31，The State Administration of Food and Drug Administration issued the "Announcement on Opinions on Soliciting Perception of Drug Registration Applications"，Makes ten opinions to improve the backlog of drug registration applications。

 

It is worth noting that the announcement mentioned the principle of consistency of generic drugs、Biological Equivalent Test Approval Reform File、Severe punishment of clinical trials to falsify、Concentrated approval of the same variety、Restricted approval of generic drug varieties catalog。These contents are implemented in the documents published after the National Bureau。According to the data of the China Pharmaceutical Industry Information Center，The supplementary application for the monthly conclusion since July shows a downward trend，The clinical applications that were concluded from less than 100 previously increased to nearly 200 pieces，The listing application for review has also risen。

 

Eight.

 

August 2，The General Office of the State Council issued the "Opinions of the General Office of the State Council on the Implementation of Urban and Rural Residents' Disease stake online sports bettingstake betting appInsurance"，This opinion is & ldquo; people -oriented、Guarantee major illness & rdquo;，It is clearly proposed & ldquo; strive to safeguard the health rights and interests of the people，Effectively prevent the people from poverty due to illness、Back to poverty due to illness。& rdquo; Opinions are also proposed until the end of 2015，Medical Insurance of Major Diseases to cover the basic medical insurance of all urban residents、New type of rural cooperative medical insurance crowd。2017，To establish a relatively complete serious illness insurance system。

 

2012，my country starts the work of urban and rural residents' serious illness insurance。During the implementation process，The biggest difference in various places is the definition of & ldquo; major illness & rdquo;，There is a disease division，There is also a paying fees。This document clearly proposes that the insured person suffers from high medical expenses in the incidence of major illnesses，It is given protection by regulations in accordance with regulations。supplemented by & ldquo; high medical expenses & rdquo; dynamic adjustment according to the disposable income of urban and rural residents in various regions，This & ldquo; expensive & rdquo; that is, & ldquo; major illness & rdquo; determination method is more scientific and more human。In addition，The document also proposes to use commercial insurance institutions to host major illness insurance，This approach can dilute risk，Extension of medical insurance funds，Let the limited medical insurance funds play & ldquo; four or two pounds & rdquo;，to benefit more patients。

 

Nine、Drug review reform & ldquo; four most stringent & rdquo;

 

August 1My stake betting app8，The General Office of the State Council issued the "Opinions of the State Council on the Approval System for Reforming the Reform of Drug Medical Devices for Reform"，Clarifying multiple drug review reforms，Including improving the approval standard for newly listed drugs、Promote the consistency evaluation work of the quality of generic drugs、Encourage the creation of new medicine、Solve the backlog of registration application、Strengthen the ability of drug technology review and improve the transparency of approval。

 

August 24th to August 25th，The Reform of the National Drug Review Approval System Reform Work Conference clarified that the reform of the drug review should adhere to & ldquo;。Repeatedly emphasized the approval and approval system of pharmaceutical medical equipment from the State Council，Promoting the opinions quickly implemented to actual policies。

 

10、& ldquo; The strictest restrictions in history & rdquo; upgrade

 

August 27，The National Health and Family Planning Commission issued the "Notice on Printing and Distributing the Principles of Antibacterial Drug Application Guidance (2015 Edition)" and "Notice on Further Strengthening the Management of Clinical Application of Antibacterial Drugs"，Selection of antibacterial drugs and product regulations、Purchasing、Prescription、Adjustment、Clinical applications and evaluations for the whole process management，Dispensing 2004 version at the same time。It is worth noting that it is，The National Health and Family Planning Commission requires all medical institutions to formulate and improve the number of antibacterial drugs、Antibacterial drug use strength、Class I -Class incision surgery to prevent antibacterial drug ratio、Microbial inspection rate and other management and control indicators，and the administrative department of health and family planning in various places inspect medical institutions in accordance with the management evaluation indicators、Evaluation and assessment。

 

In order to get rid of the title of & ldquo; antibiotics & rdquo;，Containing antibiotics abuse，my country's health regulatory authorities are becoming more and more severe on the use of antibiotics。August 2012，The "Administrative Measures for Clinical Use of Antibacterial Drugs" issued by the National Health and Family Planning Commission was due to the proposal measures for antibiotics，Strict punishment of illegal doctors is called & ldquo; the most stringent restrictions in history & rdquo;。January 2015，The "Notice on Printing and Distributing to further Improve the Medical Service Action Plan" issued by the Health and Family Planning Commission has made further restrictions on the doctor's use of antibiotics。This restrictions on this restricted order proposed to be linked to the performance of the hospital，Clarify the hospital responsibility，Further upgrade & ldquo; the most stringent restricted anti -order & rdquo;。

 

My stake betting appStake Sports Betting11. Promoting the construction of a hierarchical diagnosis and treatment system

 

September 11，The General Office of the State Council issued the "Guiding Opinions on Promoting the Construction of Hierarchical Diagnosis and Treatment System"，Proposed to 2017，To initially improve the hierarchical diagnosis and treatment policy system，Basically forming a division of labor collaboration mechanism for medical and health institutions，and formulated a detailed pilot work assessment standard。

 

According to Internet data statistics，From the perspective of geographical allocation，Urban and rural medical resources distribution is only 1/8。From the nature of medical treatment，The total number of services in public hospitals accounts for 89.8%。Hierarchical diagnosis and treatment is a good recipe for solving the problem of allocation and allocation of medical resources in my country。Control the scale of the third -level hospital、Cultivate the general doctor、Encourage the opening of an individual clinic、The pilot work of not going out of the county and special disease will help my country in the future to achieve classification diagnosis and treatment。But the hierarchical diagnosis and treatment system is based on the reform of public hospitals，Sinking of doctor resources，Patients' referrals are indispensable to cooperate with hospitals at all levels，This situation makes the establishment of a hierarchical diagnosis and treatment system as challenging as the reform of public hospitals，It can be said that this is also a system that moves the whole body。

 

Twelve、Maternal and Children's Specialty Non -Patent Drugs、Urgent (grabbing) Salvation Demonstration Demonstration Drug List Announce

 

September 16，Chinese Medical Association、The Chinese Physician Association released the "About Maternal and Children's Specialty Non -Patent Drugs、Urgent (grabbing) Salvation Drug Directly Purchase Demonstration Dharine (Chemical Drugs and Biological Products) Selection Principles and Notice of Demonstration Demonstrations "，A total of 108 varieties were selected as a list of demonstration drugs。This list has been issued one，It has become the basis for formulation of the directory in many provinces' collection programs。

 

Thirteen, Pharmaceutical Licensed Holders System Expand Pilot

 

November 4，The Seventeenth Meeting of the Standing Committee of the Twelfth National People's Congress reviewed the "Decision on Authorized the State Council's Pilot Pilot and Pilot Reform of the State Council for Pharmaceutical Licenses and Pilot Classification Reform (Draft)，Authorized the State Council to organize the pilot of the system of drug listing permit holders，Allowing drug research and development institutions and researchers to obtain the drug approval number，Affordable to the quality of drugs。

 

my country's existing pharmaceutical listing license system is the approval number system，Binding drug listing permits and enterprise production licenses，Have easy supervision，Easy to combat fake drugs to ensure the safety of people's safety。But with the continuous development of socio -economic，& ldquo; Binding & rdquo; Management gradually cannot meet the public's needs for scientific management，And the ownership of the drug can only be classified as a drug manufacturer，Also combat the enthusiasm of other institutions' new drugs。Listing license holder system，With its enthusiasm for the development of new drugs、The advantages of saving new drug research and development costs and reducing the input of duplicate construction have attracted much attention。From the perspective of management，Drug listing license holder system puts forward higher requirements for drug supervision in my country。

 

14、The new policy of the drug review & ldquo; consistency evaluation，Accelerate approval，be filing the eye -catching & rdquo;

 

November 11，The State Food and Drug Administration issued the "Announcement of the State Food and Drug Administration on several policies for drug registration review and approval (No. 230, 2015)" has made major adjustments and upgrading policies for my country's drug registration approval approval。The announcement implemented the consistency evaluation of generic drugs as a necessary basis for drug review、Clarified the drug conditions for accelerating the approval alone。In addition，Clinical trial one -time approval、Imitation drug biological equivalent test approval and reconstruction of the filing logo my country clinical trial enters the era of wide entrance。

 

Fifteen, the consistency evaluation of generic drugs began to solicit opinions

 

November 18，The State Administration of Food and Drug Administration issued the "Opinions on the Evaluation of Consistent Evaluation of the Quality Stake Sports Bettingand Consistent Effects stake online sports betting(Draft for Consultation)。In addition to passive requirements such as the 3 -year period of consistency evaluation，The National Bureau encourages enterprises to actively carry out consistency evaluation work，Release a lot of benefits。

 

The benefits of the consistency evaluation include，Variety through consistency evaluation，announced to the public by the Food and Drug Administration。Enterprise can be in the drug manual、Labels in the label to indicate the in vivo evaluation and in vitro evaluation。Enterprise can declare as a drug listing license holder for this variety，Entrusted other pharmaceutical manufacturers to produce，and assume the relevant legal liability after listing。Variety through consistency evaluation，The social security department gives appropriate support for medical insurance payment。Medical institutions are prioritized and preferred in clinical clinical。Development Reform Commission、The Ministry of Industry and Information Technology will support the technical transformation of pharmaceutical companies through consistency.。So consistent evaluation changed from previous chicken ribs to fragrant。

 

Sixteen, BE test approval for the record

 

December 2，The State Administration of Food and Drug Administration issued the "Announcement on Implementing Recording Management of Chemical Pharmaceuticals and Bio Eligibility Tests". From December 1, 2015，Equivalence (hereinafter referred to as BE) of chemicals and creatures from the approval system to filing management。The National Bureau has made a notice on this change in the new policy released by Double Eleven。The policy implementation speed is amazing。

 

Seventeen, two -fixed approved approval implementation agreement management at the end of the year

 

December 2，The Ministry of Human Resources and Social Security issued the "Guidance Opinions of the Ministry of Human Resources and Social Security on improving the management of the agreement management of the basic medical insurance"，Implementing & ldquo; Basic medical insurance fixed retail pharmacy qualification review & rdquo; and & ldquo; Basic medical insurance fixed medical institution qualification review & rdquo; cancellation at the end of the year，and propose to implement agreement management。

 

One aspect，The cancellation of the two -fixed qualification review can give full play to the leading role of the market in resource allocation，Stimulate industry competition，Form a reasonable and effective exit mechanism。On the other hand，Using Agreement Management，It can ensure the legitimate rights and interests of the agency and designated medical institutions at the same time，Help medical insurance control fees，It can also play a role in correcting the profitability of a pharmaceutical institution。