August 2015，Reform of the State Council launched the approval system for the review and approval of drug medical device，Among them, advancing the consistency evaluation of the quality and efficacy of generic drugs (hereinafter referred to as & ldquo; imitation drug consistency evaluation & rdquo;) is one of the key tasks of reform。March 5 this year，The "Opinions on the Evaluation of the Consistency of the Quality and Effects of Make Drugs" issued by the General Office of the State Council (National Office [2016] No. 8) (hereinafter referred to as "Opinions") officially announced，It marks the comprehensive expansion of the quality and efficacy of the quality and efficacy of the imitation drugs in my country。Subsequent，The State Food and Drug Administration issued the "Announcement on the Research Reference Preparation and Recommendation Procedure of the Launch of the Quality and Effects of Make Drugs" (No. 99, 2016)、"Announcement on the Release Work Procedures for the Launch of the Quality and Consistency Evaluation of the Make Drug" (2016 No. 105) and other series of documents。May 26，The General Administration also issued the "Announcement on Implementing the Implementation of the Evaluation of the Evaluation of the Quality and Consistency of the Makeup Drug" (2016 No. 106)，(hereinafter referred to as the "Announcement") deployed the consistency evaluation work of generic drugs。June 21-22，The General Administration held a working meeting for the evaluation of the quality and efficacy of the quality and efficacy in Beijing，Implement the opinions of the State Council on the evaluation of the consistency of the quality and efficacy of the State Council，In -depth promotion of the reform of the drug review and approval system。

 

  Develop the consistency evaluation of generic drugs，It is an important task proposed by "National Drug Safety & Ldquo; Twelve Five -Year Plan"，It is a major measure taken by the State Food and Drug Administration since its establishment.，It will have a profound impact on the healthy development of the pharmaceutical industry。Also because of this，The consistency evaluation of generic drugs has also been a problem with high attention in the pharmaceutical industry in the recent period。Interpretation of relevant policy issues on consistency evaluation。

 

  1. Why do you want to carry out the consistency evaluation of generic drugs?

 

  Consistent evaluation of generic drugs that have been approved for marketing，This is a lesson for history。Because the drugs we approved in the past did not have the compulsory requirements of the consistency evaluation of the original drug，So there are some gaps with the efficacy with the original drug in terms of efficacy。History，The United States、Japan and other countries have also experienced the same process，Japan has spent more than ten years to promote the consistency evaluation work of generic drugs。Develop the consistency evaluation of generic drugs，It can make generic drugs consistent with the original medicine in terms of quality and efficacy，It can replace the original medicine in clinical practice，This can not only save medical expenses，At the same time, it can also improve my country's generic drug quality and the overall development level of the pharmaceutical industry，Ensure that the public medication is safe and effective。The consistency evaluation of generic drugs is a supplementary lesson in my country，Also innovation。Be consistent with the quality and efficacy of the original drug，We are not far away from creating new medicines。

 

  2、What is the real significance of carrying out the consistency evaluation of generic drugs?

 

  The significance of this work in my country is currently in China，You can use four & ldquo; help & rdquo; to summarize:

 

  First, it is conducive to improving the effectiveness of the medicine。People must achieve safety in medication、Effective、。Since the founding of New China，Imitation drugs played an irreplaceable role in ensuring the health of the people and the development of China's medical and health undertakings。But it is undeniable that，Although Chinese generic drugs can ensure safety，But some varieties have certain differences with the original research drugs in terms of quality and efficacy。Evaluation work through consistency，The quality of imitation drugs in my country can be greatly improved，The effectiveness of the people's medication can also be guaranteed。

 

  Second, it is helpful to reduce people's medication expenses，Save medical expenses。Imitation drugs through consistency evaluation，Stake Sports BettingIts stake online sports bettingquality is the same as the original medicine。Preferential use of these & ldquo; can replace & rdquo;，Can greatly reduce the burden on the people's medication，Reduce medical insurance expenditure，Improve the use efficiency of medical insurance funds。

 

  Third, it is conducive to improving the quality of development of the pharmaceutical industry，Further promote the internationalization of the pharmaceutical industry。my country is a major pharmaceutical country，but not a powerful country of pharmaceutical。In the international pharmaceutical market，my country still takes the export of raw materials，Preparation exit, whether it is a variety or amount，The proportion of occupied by is small，The root cause of this phenomenon is the relatively backwardness of the preparation level。Consistency evaluation of generic drugs，It will continue to improve my country's medicinal auxiliary materials、Quality of bag materials and generic drugs，Accelerate the survival of the fittest in my country's pharmaceutical industry、Transformation and upgrade pace，Improve my country's preparation production level，Further promote my country's preparation products to the international market，Improve international competitiveness。

 

  Fourth, it is conducive to promoting supply -side structural reforms。Product quality is the supply side problem，How to better meet the problems of market demand，It is also a structural problem。The quality of generic drugs has been improved，Clinically realized alternative with the original medicine，can promote structural reforms in the field of drug production，Change the situation where the drug sales ratio of the original drug in some large hospitals reaches 80%，It is conducive to reducing total medical expenses，It is conducive to eliminating backward production capacity，Improve the competitiveness of generic drugs。Pharmaceutical companies through the assessment of consistency of generic drugs，It is also conducive to innovation。Preparation is an effective ingredient、Organic combination of accessories and packaging materials，Consistency evaluation will promote enterprises to carry out more production technology and auxiliary materials、Comprehensive research on bag materials，Comprehensively improve preparation level。

 

  3、What are the guarantee measures for the smooth development of the consistency evaluation of generic drugs?

 

  First of all, to build a hand，Food and Drug Administration under the framework of the leading group of the review and approval system of drug medical equipment，Established an Evaluation Office of the Consistent Drug。Consistency Evaluation Office is responsible for consistency evaluation work，Organize experts to review and determine the reference preparation; evaluate the consistency evaluation materials submitted by the enterprise; consult the relevant policies and work procedures，and responsible for organizing the technical requirements of the Organizational Drug Examination Center for the technical requirements of biological equivalent tests and clinical validity tests, inquiring and guidance; responsible for organizing inspection centers to check the production site、Technical requirements for the research and development site inspection and clinical verification of the work for consultation and guidance; responsible for organizing the technical requirements of the Chinese Food and Drug Inspection and Research Institute and undertaking the review and inspection of the review and inspection work for the technical requirements of various varieties of review and inspection。

 

  Second, the team of experts，Consistency Evaluation Office organizes the establishment of an expert committee，Professional scope coverage of pharmacy、Clinical Medicine、Drug Economics、Statistics、Law, etc.。The expert committee is responsible for the selection of evaluation varieties of the consistency evaluation office、Reference Preparation Review、Variety Evaluation and other tasks put forward consultation opinions; be responsible for reviewing results and variety evaluation results of the reference preparation; responsible for the overall deployment of consistency evaluation、Major policies and key technical issues provide decision -making consulting opinions。

 

  The third is the construction of an information platform，Strengthen information disclosure。Food and Drug Administration and the China Food and Drug Inspection Research Institute opened & ldquo; Microcontrolist consistency evaluation & rdquo; information column，Release the progress of the consistency evaluation work in time，Public reference preparation filing、variety declaration、Acceptance and other dynamic information，Comprehensive guidance and standardization of enterprises to carry out consistency evaluation work。Consistency Evaluation Office to speed up the establishment of a special information work platform，Informatization management of the workflow，Make sure the consistency evaluation work is open and transparent。

 

  The fourth is the supervision mechanism，Requires provincial food and drug supervision and management departments shall be in accordance with the requirements of the Announcement，Do a good job of supervision of the consistency evaluation of pharmaceutical manufacturers in the administrative area，At the same time, implement information acceptance、On -site inspection and sampling test、Data summary and submission work。

 

  Stake Sports Betting4. Stake Sports BettingWhat are the scope of launching consistency evaluation?

 

  New registration of chemical drugs is approved before the implementation,，Whether it is domestic generic drugs，Still imported generic drugs、Original Research Drug Real Estate Variety，Approval of the principle of consistency of the quality and efficacy of the original drug，All consistency evaluations must be carried out。

 

  The first batch will conduct a consistency evaluation。In principle。Why do you first conduct consistency evaluation of the chemical drug oral solid agent in the basic drug directory? There are two main points: one is because of oral solid dosage doses and wide faces、The most commonly used; second, basic drugs are varieties that ensure the basic medication needs of the masses。

 

  Other chemicals other than the above -mentioned chemicals imitated drugs oral solid -solid institutional agents，Enterprise can organize consistency evaluation work，Since the first variety passes the consistency evaluation，No longer accepts the consistency evaluation application of the same variety of other pharmaceutical manufacturers in three years。

 

  Other chemical generic drugs except the above generic drugs，Including drugs of other dosage types in the basic drug directory，varieties of non -basic medicine directory, etc.，Because there are many varieties、Complex situation，The State Food and Drug Administration will release the list of varieties for the evaluation of quality and efficacy consistency evaluation in batches。For these varieties，Encourage everyone to conduct evaluation in advance。

 

  5、How should a pharmaceutical manufacturer respond to consistency evaluation?

 

  Consistency Evaluation Work，It is both a challenge and an opportunity。Opinions clearly stipulate，Drug production enterprises are the main body of consistent evaluation。The list of varieties of the State Administration of Food and Drug Administration released the list of consistency evaluations，Drug production enterprises should compare the list released by the General Administration，Research on the assessment of consistency evaluations produced in stages in batches。

 

  Preliminary statistics，Chemical drugs for chemical drugs approved by October 2007，There are 289 varieties in the base medicine directory、17740 approval number or registration certificate number，Involved in 1817 domestic production enterprises、42 imported drug companies。I can't do so many medicine numbers，Can't do it，No necessary。Consistency Evaluation is a question of life and death for enterprises，It is a process of survival of the fittest，How much is meaningless，The varieties with the same quality efficacy as the original drug can have market value。Enterprises need to choose a variety of confidence，Pay crystal type、Accessories、Crafts and other basic research，Test of in vitro dissolution，Renew biological utilization clinical trial，Take less detours。A company has several varieties to complete the consistency evaluation，Plus the implementation of the system of listing permit holder，You can get opportunities in the competition。

 

  Drug production capacity in my country is serious excess excess，Excessive number of enterprises，Some enterprises are not consistent evaluation very normal。Pharmaceutical companies through consistency evaluation，It can be used as a list of drugs for drugs to entrust other companies to produce; enterprises that are not consistent evaluations，You can use your own advantages to engage in the commission processing of drugs。The key is that the enterprise needs to be positioned。

 

  6、How should an enterprise scientifically arrange consistency evaluation work?

 

   Drug manufacturers who do consistency evaluations，First of all, refer to the requirements of the "General Oral Oral Solid Preparation Preparation Preparation and Determining Principles of Guidance" (announcement of the General Administration of Food and Drug Administration 2016).。According to the "Requirement and Recommendation Procedures for the Evaluation Reference Preparation Preparation Preparation Preparation Preparation Preparation Preparation Preparation Preparation Preparation of the Quality and Effects" (Announcement of the General Administration of Food and Drug Administration No. 99)，The selected reference preparation to the Evaluation Office of the Quality Consistency Evaluation Office (hereinafter referred to as & ldquo; consistency evaluation office & rdquo;)。Industry Association can recommend reference preparations to consistency evaluation office，Original Research Drug Production Enterprise、Internationally recognized pharmaceutical manufacturers can declare reference preparations to the consistency evaluation office。Consistency Evaluation Office actively filing the reference preparation、Recommended and declared information disclosure to the society。Food and Drug Administration announced the recommendation and determined reference preparation information，Drug production enterprises should choose the announcement of the reference preparation to carry out consistency evaluation。

 

  For the company that cannot be found and cannot determine the reference preparation，The clinical validity test should be conducted by a pharmaceutical manufacturer。

 

  During the process of launching consistency evaluation，Drug production enterprises must take the reference preparation as the control，Comprehensive and in -depth comparative comparison research。Including prescription、Quality Standards、Crystal type、Comparison Stake Sports Bettingof major pharmacy indicators Stake Sports Bettingsuch as particle size and impurities，and comparative research on the solid -made agent dissolved curve，To improve the success rate of the biological equivalent test，and provide a basis for the inclusion of drug characteristics into the corresponding quality standards。For the variety that meets the "Principles of the Principles of the Exemption Guidance of Human Bio Equal Tests"，It is declared by a pharmaceutical manufacturer，Consistency Evaluation Office Organization Organized after review，Allows the drug manufacturer to adopt the method of in vitro dissolving test for consistency evaluation。

 

  Variety of biological equivalent tests，Announcement of the "Announcement on the Implementation of File Management on Chemical Pharmaceutical Bioquisions Tests" (announcement of the General Administration of Food and Drug Administration 2015 No. 257) registered，and follow the relevant requirements of the relevant requirements of the relevant requirements of the "Principles of the Principles of the Pharmaceutical Parameters as the final evaluation index of the chemical drugs" (the State Administration of Food and Drug Administration announced the announcement of 2016), etc.。

 

  varieties that need to conduct clinical validity tests for non -paramembling preparations，Two cases should be distinguished: (1) If it is an unchanged prescription、Crafts，Should be recorded in accordance with the requirements of the consistency evaluation office，and conduct experimental research in accordance with the corresponding requirements of the guidance principle of the drug clinical trials; (2) If it is a change of the approved prescription、Crafts，Performance research on the application of the "Administrative Measures for the Registration of Drugs"。

 

  Seven. Regarding the shortage of clinical trial resources.

 

  Some companies reflect the shortage of clinical trial resources，It may affect consistency evaluation work。Enterprises should face up to this question，Can't wait to wait and see because of clinical resources，Disclosure of timing。

 

 On the other hand，The State Administration of General Administration is also hasscating to solve the problem of the shortage of clinical resources。There are 475 clinical drug test agencies that are currently qualified by the General Administration.，and concentrated in the third -class hospital。The General Administration has communicated with the State Health and Family Planning Commission，Considering the adjustment of the qualification identification to filing management，Announcement has been drafted，Solving the opinions of relevant departments。After implementing the filing management，The contradiction of tight clinical trial resources can be relieved。Some reflected high clinical trial costs，This should be analyzed for specific analysis。Clinical trials to occupy medical resources，Clinical trial costs must not only compensate the hospital's opportunity cost，Also compensate the salary cost of medical staff，This can mobilize the enthusiasm of medical staff。

 

  eight、Understand different application and acceptance departments of different varieties of generic drugs

 

  After completing the consistency evaluation research，Should be reported in accordance with the "Work Procedures for the Evaluation of the Quality and Consistency Evaluation of the Make Drug" (announcement of the General Administration of Food and Drug Administration 2016): Domestic generic drugs are responsible for the consistency of the provincial food and drug supervision and management department in charge of the administrative area The receiving and related supplementary application materials of evaluation materials，Organize the development site inspection and production site inspection，Three batches of continuous samples of continuous production on -site were sent to the designated pharmaceutical inspection agency for review and inspection。After completing the above work，Summary by the provincial food and drug supervision and management department to submit the consistency evaluation office。Imported generic drugs are accepted by the Administrative Service and Complaint Reporting Center of the State Administration of Food and Drug Administration (hereinafter referred to as acceptance and reporting center)，Formation of the application information，and notify the enterprise to send three samples to the designated pharmaceutical inspection agencies for review and inspection。After completing the above work，Summary of the Consistency Evaluation Office from the Acceptance and Report Center。

 

  Nine、Note & ldquo; deemed & rdquo;

 

  First, use the same production line in China to produce and listed and in the European Union、Pharmaceuticals approved by the United States or Japan，The acceptance and reporting center is responsible for the application of information to accept; the consistency evaluation office notify the Food and Drug Administration of the Drug Review Center (hereinafter referred to as the drug review center) to the original territory、Outer listing declaration information for review，Notification of Food and Drug Review and Inspection Center of the State Administration of Food and Drug Administration (hereinafter referred to as & ldquo; Checking Center & RDQUO;) check the production site。Consistency Evaluation Office review and approval deemed to pass the consistency evaluation。

 

  Second, domestic drug manufacturers have been in the European Union、The US or Japan's approved imitations，According to the "Announcement on Research on the Reform of the Reform of Chemistry Drug Registration and Classification" (relevant requirements of the Food and Drug Administration announced No. 51, 2016)，Review from the Drug Stake Sports BettingAudit Stake Sports BettingCenter，After approval, it is deemed to pass the consistency evaluation。

 

  This is also an encouragement of pharmaceutical companies in our country to actively enhance their international competitiveness，Can more、Better、Go to the international market faster，Participate in international competition places。

 

  10. Use enough related support and encouragement policies

 

  Consistency Evaluation is a need for enterprises to invest funds、Quality of Technology and Time、Scientific research of process improvement and technological improvement，For the variety of generic drugs that have passed consistency evaluation, more support policies should be given。Drug varieties that pass the consistency evaluation，announced by the General Administration to the society，Pharmaceutical manufacturers can be in the pharmaceutical manual、Label in the label。Enterprises in the pilot area of ​​the holder system of drug listing permits，Can be declared as a listing permit holder of this variety of drugs，Entrusted other pharmaceutical manufacturers to produce，and assume the relevant legal liability after listing。

 

  What can be clear now is，To encourage enterprises to conduct the consistency evaluation of generic drugs，The state will pay in medical insurance、Policy support。What has been reached at present is: drug varieties that pass the consistency evaluation，The social security department will appropriately support medical insurance payment，Medical institutions should prioritize and choose in clinical clinical use。Production enterprises with consistency evaluation through the same variety of medicines，The health and family planning department will no longer choose varieties that have not been approved in terms of centralized procurement of drugs。Technical transformation of drug manufacturers through consistency evaluation，In the case where the relevant conditions are met，Can be reforming reform、Industry Information and Finance and other departments apply for central infrastructure investment、Industrial Fund and other fund support。

 

   eleven、Careful implementation of the General Administration of Executive Bureau，Actively promote work development

 

  The consistency evaluation work of generic drugs，Sometimes limit requirements，Quality requirements。Pay attention to all places，Director must personally supervise，Strengthen leader，Coordinated coordination，Improve various working mechanisms，Research and solving problems encountered in the work。

 

   In order to make the consistency evaluation work of generic drugs smoothly carried out，Each department should do the following points: First, we must carefully study the spirit of Document No. 8 of the National Office of the Conference; the other is to establish and continuously improve the working mechanism; the third is to effectively fulfill the work responsibilities; the fourth is to strengthen policy publicity，Mobilize the enthusiasm of the enterprise; the fifth is to actively strive for multiple support; sixth, strict work discipline requirements。

 

 

 

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