Opinions of the General Office of the State Council on the evaluation of the consistency evaluation of the quality and efficacy of generic drugs

National Office [2016] No. 8

Each province、Autonomous Region、The People's Government of the Municipal Municipality，All Ministries and Commissions of the State Council、Direct institutions:

Carry out the consistency evaluation of the quality and efficacy of generic drugs (hereinafter referred to as consistency evaluation) work，To improve the overall level of my country's pharmaceutical industry，Guarantee drug safety and effectiveness，Promote the upgrade of the pharmaceutical industry and structural adjustment，Enhance international competitiveness，It has very important significance。According to the "Opinions of the State Council on Reforming the Approval System for Reform of the Reform of the Medical Devices and Medical Devices" (Guofa [2015] No. 44)，Agree with the State Council，The following comments are now made on the consistency evaluation work:

a、Clear evaluation objects and time limit。New registration of chemical drugs is approved stake betting appby the My stake betting apppublication before implementing it，Anyone who has not been approved in accordance with the principles of the quality and efficacy of the original drug，All consistency evaluations must be carried out。National Basic Pharmaceutical Catalog (2012 Edition) In the chemicals of chemical drugs approved by October 1, 2007，The consistency evaluation should be completed by the end of 2018，Among them, a variety of clinical effectiveness tests and special circumstances，The consistency evaluation should be completed by the end of 2021; if the overdue is not completed，No registered。

Other generic drugs approved before the implementation of chemical drugs，Since the first variety passes the consistency evaluation，The same variety of other pharmaceutical manufacturers should be completed in principle within 3 years; if the overdue is not completed，No registered。

2、Determine the selection principle of the reference preparation。Destination preparation In principle, the original research medicine，You can also choose the internationally recognized medicine。Pharmaceutical manufacturers can choose their own reference preparations，Report the Food and Drug Administration for record; the State Administration of Food and Drug Administration does not raise objections within the prescribed period，Drug production enterprises can carry out related research work。Industry Association can organize the choice of reference preparations for the same variety drug manufacturers，Report the Food and Drug Administration for review and determination。There is controversy for the reference preparations，Organizes by the Food and Drug General Administration of Food and Drug Administration to determine after the experts are publicly demonstrated。Food and Drug Administration is responsible for publishing reference preparation information in time，Drug production enterprises should choose the announcement of the reference preparation Stake Sports Bettingto stake sports betting appcarry out consistency evaluation work。

3、Reasonable selection of evaluation methods。Pharmaceutical manufacturers should adopt the method of biological equivalent tests in the body for consistency evaluation。varieties that meet the principles of exemption of biological equivalent test，Allowing drug manufacturers to adopt the method of in vitro dissolution test test for consistency evaluation，The list of specific varieties will be announced separately by the Food and Drug Administration。When conducting a test of biological equivalent test，Drug production enterprises shall organize implementation in accordance with the relevant provisions of the equivalent test of generic drug biology。with non -participants，Clinical validity tests from pharmaceutical manufacturers。

4、Implement the main responsibility of the enterprise。Drug production enterprises are the main body of consistency evaluation，It should be actively purchased by the participation preparation to carry out related research，Ensure that the quality and efficacy of the drug are consistent with the reference preparations。After completing the consistency evaluation，The evaluation result and adjustment prescription can be adjusted、Process information，Application procedure according to drug registration，Submit the food and drug supervision department。Domestic pharmaceutical manufacturers have been in the European Union、Imitation of the United States and Japan forum，The relevant information that can be registered abroad，Applying for drug listing according to the new registered classification of chemicals，After approval, it is approved to pass the consistency evaluation; use the same production line in China to produce and listed and in the European Union、Drugs approved by the United States and Japan，See it through consistency evaluation。

5、Strengthen the management of consistency evaluation。Food and Drug Administration is responsible for publishing relevant guidance principles for consistency evaluation，stake online sports bettingstake betting appStrengthen the technical guidance of the consistency evaluation work of drug manufacturers; organize experts to review the reference preparation information reported by the enterprise，In the stages, the reference preparation directory determined by the review was announced in batches，Establish a catalog set of my country's generic drug reference preparations; timely and announced the directory set of the drug income reference preparation preparation in accordance with the new standard; set up a unified review channel，Reviewing the consistency evaluation data submitted by the company and the application for drug registration supplement。Drug production enterprises purchase their own reference preparations that have not yet been listed in China，Approved by the State Administration of Food and Drug Administration in one -time import，For consistency evaluation research and use。

6、Encourage enterprises Stake Sports Bettingto stake sports betting appcarry out consistency evaluation work。Drug varieties that pass the consistency evaluation，announced to the public by the Food and Drug Administration。Pharmaceutical manufacturers can be in the pharmaceutical manual、Labels in the label; Enterprises in the pilot area of ​​the holder system of drug listing permits，Can be declared as a listing permit for the species of this variety of medicines，Entrusted other pharmaceutical manufacturers to produce，and assume the relevant legal liability after listing。Drug varieties that pass the consistency evaluation，Proper support for medical insurance payment，Medical institutions should prioritize and choose in clinical clinical use。Production enterprises with consistency evaluation passed by the same variety of medicines，varieties that have not been approved in terms of drug centralized procurement。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。

Each region、Each relevant departments should pay stake sports betting appstake online sports bettingattention to，Organizational guidance drug manufacturers actively participate，Scientific and standardized work -related work。Food and Drug Administration should strengthen guidance with relevant departments，Implement relevant supporting policies，Jointly promote consistency evaluation work。

The General Office of the State Council

February 6, 2016