I. "Announcement stake betting appon the Evaluation of the Matters of Consistency of the Quality and Consistent Effects of the Make Drug" (2017 No. 100，The following is referred to as the "Announcement")?
Opinions of the "General Office of the State Council stake betting appon the Evaluation of the Consistency of the Quality and Consistent Effect of Photics" (National Office Fa [2016] No. 8)，Evaluation of the Consistency of the Quality and Consultation of Imitation (hereinafter referred to as consistency) work is solidly advanced，Some companies have completed some varieties of research，Enter the application review stage。To further strengthen the guidance of enterprises，Improve work efficiency，Our bureau summarized and analyzed the early work，Research formulated this "Announcement"，Optimized adjustment of the consistency evaluation work，It aims to guarantee acceptance、Check、Inspection and review and other links smoothly，A unified evaluation criteria。
2. Determination and obtaining the reference preparation，What optimization measures are proposed in the "Announcement"?
In order to facilitate the company's research work，The General Administration has released 8 batches of 610 varieties specifications for reference preparations，Including "Opinions on the Implementation of the General Office of the State Council stake betting appon the Evaluation of the Consistency of the Quality and Consistent Effects of the State Council ﹥ Related matters (relevant matters of the relevant matters" (2016 No. 106) "The Evaluation of Consistency of Photos Before the end of 2018 must be completed by the end of 2018) The 163 varieties (hereinafter referred to as "289 Variety Catalog" (hereinafter referred to as the "289 Variety Catalog)。About 90 varieties in this directory are changed specifications、Modified dosage type、The variety of salt -changing base，According to the "Evaluation of Modeling Drugs (Oral Solid Institutions) in the Evaluation of the Quality and Consistent Effect Evaluation of the Make Drugs", "General Implementation of the Modified Dabbon (Oral Solid Instant) Evaluation in the Consistency Evaluation of the Quality and Effect of the Make Drug" is generally considered " "General consideration of the Evaluation of Salt Pharmaceuticals in the Evaluation of the Evaluation of the Quality and the Consistency Evaluation of the Make Drugs" and other technical guidelines，The above stake sports betting app-mentioned changes、Modified dosage type、The basis for choosing the reference preparation of about 90 varieties of salt -based varieties is also clear。So far，Selection of the reference preparations of most varieties in the "289 Variety Catalog" gives guidance。"Announcement" On the one hand, the order of the selection of reference preparations is further clear，On the other hand, it is clear that our bureau will continue to select and confirm the reference preparation of the company's filing，Release Reference Directory Catalog Catalog comply with the reference preparations。
About the reference preparation obtaining matters，Enterprises can apply for a one -time import application and import filing、Clearance and other procedures to get the reference preparation，In addition，"Announcement" clearly that the company can also obtain reference preparations in other ways，When submitting consistency evaluation information，Only need to provide a purchase voucher in the information、Product packaging and instructions，or to prove the authenticity of the reference preparation with other appropriate methods。
3. Independent behavior of choosing a reference preparation for enterprises，Do you clarify the responsibilities of the company?
"Announcement" Article 3 proposes，Enterprise's own reference preparation products purchased from overseas，The reference preparation products found in the company are fake products，Time to terminate related work in time，"Allow the situation as responsibilities"，What situation is given free，How to grasp the standard，How to ensure the accurate execution of accountability exemption，No accidental injury or indulgence?
Enterprise is responsible for the selection of reference preparations、Buy and use，Responsible for the whole process。After discovering the reference preparation stake sports betting appproduct is fake products，The General Administration will investigate in accordance with the law，According to the results of the survey，If there is evidence to prove that the company's non -subjective factors choose counterfeit products，can be exempted。
4. For the problem of deficiency of clinical institutions，What solutions are proposed?
"Insufficient" problem for biological equivalent test agencies，The Announcement proposes: First, implement a filing system for biological equivalent test agencies。Biological equivalent tests in consistency evaluation can be performed in the existing identified clinical trial institutions，It can also be performed in other conditional institutions。Our bureau has determined 619 clinical trial institutions with the Health and Family Planning Commission in the early stage。Our Bureau is studying and formulating supporting regulations related to filing management。Second, the sixth is the sixth、7、eight、In the nine articles, it proposes to meet the exemption conditions or can be exempted from evaluation.，According to the scientific judgment，Reduce unnecessary biological equivalent test。
5. Announcement proposed，Biological equivalent test sponsor can hire a third party with evaluation ability to conduct evaluation of biological equivalent test agencies according to GCP。How can I clearly define the third -party evaluation ability?
The biological equivalent test in the consistency evaluation can be performed at the existing identified clinical trial institution，It can also be performed in other conditional institutions。If you choose to choose in other institutions with conditions，Biological equivalent test applicants can hire third parties with evaluation ability in accordance with the requirements of the "Quality Management Specifications for the Clinical Test of Drugs" (GCP) requirements to evaluate the institutions that carry out biological equivalent tests。Third -party evaluation is an effective external improvement mechanism，It can make up for some applicants for limited ability，Can't be accurate、System evaluation The shortcomings of the selection agency。The third -party evaluation agency is responsible for the evaluation results。To give full play to the decisive role of the market in resource allocation，Through market -oriented competition，Applicants can choose to have a better foundation、rich experience and obtained a widely recognized third party。Related industry organizations can formulate self -discipline industry rules and technical specifications，Improve the third -party evaluation mechanism。
6. For the variety that conforms to the "Principles of Human Bio Equal Test Examination Guidance"，and varieties that are not suitable for developing in -human research，Enterprises can submit an exemption application to the General Administration and explain the reason。What about the exemption process，Is there any relevant regulations?
Study on exemption of human biological equivalent in consistency evaluation work，It should be treated scientifically and prudently。Relevant exemption requirements for enterprises can be proposed according to the following process:
(1) The applicant can apply to the Pharmaceutical Review Center of the State Administration，The content includes the specific situation of the variety、Exempt the scientific basis of human biological equivalent test (hereinafter referred to as be)，Posted a public document to the Pharmaceutical Review Center of the General Administration to apply for BE exemption，The Pharmaceutical Review Center of the General Administration will be evaluated according to the specific conditions of the variety。
(2) For exemption varieties announced by the General Administration，The applicant can indicate exemption in additional applications when applying for consistency evaluation，and submit the relevant basis for exemption in the application information。The Pharmaceutical Review Center of the General Administration will conduct review according to the specific conditions of the variety。
7. Announcement mentioned，When the enterprise submits consistency evaluation applications，It is necessary to review and inspect it by relevant agencies，Can it be tested by a third -party institution here? What specific standards are when choosing a third -party agency?，Which institutions should be passed for inspection?
When the enterprise submits consistency evaluation application，The reporting information shall include a drug review inspection report。The applicant can be inspected or entrusted to the statutory drug inspection agency、Other third -party inspection agencies are performed。The announcement of the Consistency Evaluation Office of the General Administration of Consistency before the release of the announcement，The variet，Enterprises can test in the inspection agency，You can also conduct inspection in other institutions。An institution issued a inspection report，It shall pass the laboratory qualification identification and national laboratory stake betting apprecognition，Organization、Management System、Test ability、Personnel、Environment and facilities、Equipment and standard substances meet the requirements of drug test，The ability to carry out drug test。
Drug Review Center during the review process，You can propose to test the specifications，After the review and inspection center of the General Administration is sampled，Pay the legal drug inspection agency for inspection。For the varieties of the previous announcement, the variety of review and inspection agencies，Test from the designated institution; the unspecified，A separate specification of the Consistency Evaluation Office of the General Administration。
8. Regarding the variety of unclear reference preparations，How to solve the problem of consistency evaluation，It is waiting for the expert consulting committee to be determined and then carried out，It will still propose other solutions，To ensure that the enterprise completes the evaluation work within the prescribed time limit?
The Pharmaceutical Review Center of the General Administration will organize research and discuss issues related to the variety of reference preparation varieties as soon as possible; applicants can also be based on the variety，According to the "Notice on Further Strengthening Consistent Evaluation Related Consultation Services" in accordance with the Pharmaceutical Review Center of the General Administration of General Administration，The State Administration of Pharmaceutical Review Center will reply。
Nine.，What encouraging policies have been established in centralized procurement of drugs? How to ensure that these policies really land?
"Opinions of the General Office of the State Council stake betting appon the Evaluation of the Consistency of the Quality and Consistency of the Make Drugs" (Guoqi Fa [2016] No. 8) regulations，Drug varieties that pass the consistency evaluation，Appropriate support for medical insurance payment，Medical institutions should prioritize and choose in clinical clinical use。15228_15252，No longer selected varieties that have not been approved in terms of centralized procurement of medicines。Technical transformation of drug manufacturers through consistency evaluation，Under the circumstances that meet the relevant conditions，You can apply for central infrastructure investment、Industrial Fund and other fund support。"Several Opinions of the General Office of the State Council on further reform and improvement of drug production circulation and use policies" (National Office Fa [2017] No. 13) further stipulate，Drugs that pass the consistency evaluation，Relevant information to the society in time，and incorporate it into the directory of the drug with the original drug。15228_15252，No longer selected varieties that have not passed consistency evaluation in centralized procurement of drugs;，Priority procurement and use varieties that have passed consistency。Relevant departments will speed up the formulation of medical insurance payment standards in accordance with the general name，Incentive mechanisms that are conducive to the use of imitation drugs through consistency evaluation as soon as possible。In the later period, our bureau will cooperate with the relevant departments to make a good policy of policies。The above -mentioned policy environment will create a policy of supporting and eliminating inferiority，Improve the concentration of the pharmaceutical industry，Guide superior enterprises to form a scale effect，Reduce cost，Guarantee market supply，Promote the formation of enterprises，Professional production pattern。
10. "Announcement" Article 16 mentioned，"Through consistency evaluation" logo is a drug label for passing or depending on the consistency evaluation of drugs、Identification of the Manual。Does the company need to apply for a pharmaceutical manual change?
"Announcement" proposed that our bureau will issue announcements to varieties that pass consistency evaluation。This work will be considered with the work of the "Orange Book" in the future，Special release of a class of announcements，Clearly published the drug directory and related information that passed the consistency evaluation，and continuously improve and develop based on this，"Orange Paper" formed China's "Orange Book"。Variety through consistency evaluation，Domestic Drug News Provincial Food and Drug Supervision Department File，Imported Drug Newsable State Food and Drug Administration after the filing can be recorded in the manual、Tags use the "Passing Consistency Evaluation" logo。
Eleven. Is there any adjustment to the content of the consistency evaluation issued in the past in the past?
The content of this "Announcement" mainly evaluates the consistency and accepts、Review、Check、Inspection and other working procedures for adjustment，and did not specify the previous file part of the file，For example, "Notice on the Selection and Determining Principles of the Release of General Oral Solid Destiny Destination Preparation Preparation Preparation Preparations" (announcement、"Announcement on Implementing the Opinions of the General Office of the State Council stake betting appon the Evaluation of the Evaluation of the Quality and Effects of Make Drugs" (Announcement on the Evaluation of the Matters of Consolidation of the Quality and Effects "(the announcement of the General Administration of Food and Drug Administration No. 106, 2016)、"Announcement on the Launch of the Work Procedures for the Evaluation of the Quality and the Consistency Evaluation of the Make Drug" (announcement of the General Administration of Food and Drug Administration No. 105) and other documents, etc.。
Twelve. As before the end of 2018，Some basic drugs oral solid -system varieties cannot complete the consistency evaluation，What are the considerations of the General Administration of Food and Drug Administration?
Enterprises shall be in accordance with the requirements of the "Opinions of the General Office of the State Council stake betting appon the Evaluation of the Consistency and Consistency of the Quality and Effective Effects" (National Office [2016] No. 8)，Complete the consistency evaluation work of the basic drug oral solid preparation variety on time。The General Administration will continue to strengthen the guidance of enterprises，Scientific Organization review work，Pay close attention to the progress of the variety。For varieties that affect market supply due，The General Administration issued a list with relevant ministries and commissions，Encourage enterprises to develop and declare imitation drugs，To ensure market supply。
Thirteen. In the EU、The United States or Japan is listed but not listed in China，It is confirmed by clinical studies to confirm that there is no racial difference，Research on biological equivalent can be used in overseas listing、Data and other technical information of pharmacy research shall submit a listing application to the State Food and Drug Administration; there may be racial differences，The corresponding clinical trial should be carried out。The review passed by the review is deemed to pass the consistency evaluation。Why consider race differences?
Imitation drugs that have been listed in Europe, America and Japan，Research on biological equivalent can be used in overseas listing、Pharmaceutical research data and other technical data proposes to list for listing，Prove the consistency of its quality and efficacy with the original research。but，Since this product is not listed in China，There may be race differences，So，Whether its usage and dosage applies to the Chinese population，It also needs further test research。
14. For the original real estate varieties，What policies will the General Administration guide it?
The "Announcement" has clearly specified the path of the original research enterprise's production and listing in China，The General Administration will release detailed data requirements for follow -up。It belongs to a large change after listing，or after listing, a large change occurs, but the review does not affect quality and efficacy，The review and verification of the General Administration can be included in the reference preparation directory，Published uniformly during the release of the reference preparation directory。
It belongs to major changes that occur after listing and have different quality and efficacy of the same product as native countries，Enterprise issued a statement by the company，Explain the differences and reasons for the existence，and conduct consistency evaluation as required。
Fifteen. When the enterprise encounters a problem with the consistency work,，Is there any feedback channel?
Specific problems encountered by the company in research，You can follow the "Notice on Further Strengthening Consistent Evaluation Related Consultation Services Work"，Consultation to the drug review center。Drug Examination Center will study the problems raised by the enterprise。
16. In Article 8 of the Announcement，Application for imitation drug registration accepted by the registered of the original chemical drugs，The applicant shall apply to the Drug Review Center of the Food and Drug Administration of Food and Drug Administration.，What channels can I apply for?
The situation of Article 8 of the Announcement，The applicant can apply in writing to the center to apply to the center to apply in accordance with the standard review of the quality and efficacy of the original drug，and pay the fee in accordance with relevant regulations。
17. As the time limit at the end of 2018 is approaching，There is not much time left for the enterprise。What measures will the General Administration take to promote consistency evaluation work，If you think about the original real estate varieties，How to guide companies to obtain reference preparations，How to apply for BE exemption，Can the regulatory authority be based on the actual situation (such as the reference preparation can be available、Is the clinical efficacy clear and other indicators) Classification of drugs，Consistency evaluation，Appropriate extension of some special varieties?
The "Announcement" has clearly specified the path of the original research enterprise's production and listing in China，Fine refined data requirements will be released in follow -up。
In order to facilitate the company's research work，The General Administration has released 8 batches of 610 varieties specifications for reference preparations，Including 163 varieties in "289 Variety Catalog"。About 90 varieties in this directory are changed specifications、Modified dosage type、The variety of salt -changing base，According to the change specification、Modified dosage type、Technical Guide related to the consistency evaluation of salt -based generic drugs，The above stake sports betting app-mentioned changes、Modified dosage type、The basis for choosing the reference preparation of about 90 varieties of salt -based varieties is also clear。So far，Selection of the reference preparations of most varieties in the "289 Variety Catalog" gives guidance。"Announcement" On the one hand, the order of the selection of reference preparations is further clear，On the other hand, it is clear that our bureau will continue to select and confirm the reference preparation of the company's filing，Release Reference Directory Catalog Catalog comply with the reference preparations。About the reference preparation obtaining matters，Enterprises can apply for a one -time import application and import filing、Clearance and other procedures to get the reference preparation，In addition，"Announcement" clearly that the company can also obtain reference preparations in other ways，When submitting consistency evaluation information，Only need to provide a purchase voucher in the information、Product packaging and instructions，or to prove the authenticity of the reference preparation with other appropriate methods。
About be exemption，The Pharmaceutical Examination Center of the General Administration will announce the BE exemption directory in batches on the basis of careful research，Enterprise can send a public document to the Pharmaceutical Review Center of the General Administration to apply for BE exemption，You can also indicate exemptions in additional applications when applying for consistency evaluation，and submit the scientific basis for exemption in the application information。
Resources for the trial institution for biological equivalent，Our bureau has determined 619 clinical trial institutions with the Health and Family Planning Commission in the early stage。In addition, the "Announcement" proposes to implement a filing system for biological equivalent test agencies。Our Bureau is studying and formulating supporting regulations related to filing management。
"Announcement" integrates acceptance、Review、Check、Inspection and other resources，and adjust the main department of consistency evaluation review to the drug review center。Specific problems encountered by the company in research，You can follow the "Notice on Further Strengthening Consistent Evaluation Related Consultation Services Work"，Consultation to the drug review center。Drug Examination Center will study the problems raised by the enterprise。
18. For companies that generally give up evaluation and the market needed for the market，Imitation takes a certain time，Thus may cause the medication of the medication，Can you consider the continuation period of these drugs?
The General Administration is in promoting consistency evaluation work，will continue to strengthen the guidance of enterprises，Scientific Organization review work，Pay close attention to the progress of the variety。Affecting market supply、No alternative varieties，The list of the General Administration will timely release the list with relevant ministries and commissions，Encourage enterprises to develop and declare imitation drugs，Accelerate the review and approval，To ensure market supply。
The General Administration will make progress based on consistency evaluation，Published related supporting documents in time，and do a follow -up interpretation。
