The State Food and Drug Administration officially issued a document to evaluate the end of the year for consistency and confirm the extension!

On December 28, the official website of the State Food and Drug Administration issued the "Announcement of the State Drug Administration on Matters Concerning the Quality and Efficacy Consistency Evaluation of Generic Drugs (2018 No. 102)", and at the same time issued the "Regarding the Quality and Efficacy Consistency of Generic Drugs" Interpretation of the "Announcement on Evaluation Related Matters" policy.

Consistency evaluation expired on December 31, canceled!

Regarding the time limit requirements for consistency evaluation, the announcement of the State Food and Drug Administration clearly stated that "time is subject to quality, and the relevant work time limits and requirements should be adjusted reasonably":

"For generic drugs including essential drug varieties approved for marketing before the implementation of the new registration classification of chemical drugs, after the first product has passed the consistency evaluation, the consistency evaluation of the same varieties of other drug manufacturers should in principle be completed within 3 years. Overdue If it is not completed, if the company considers it to be clinically necessary or in short supply, it may submit an application for extension of evaluation to the local provincial drug regulatory authority. After the provincial drug regulatory authority and the health administrative department organize research and identification, the extension may be appropriately extended. Those who fail to complete the registration after the expiry date shall not be re-registered".

That is to say, the December 31st limit for the consistency evaluation of the "289 Essential Medicine Catalog" has been cancelled! cancelled! cancelled!

With only the last few days left before the end of 2018, all medical professionals are nervous. Because, for the varieties in the "289 Basic Drug List", the consistency evaluation is about to come.

In accordance with the previous requirements, for the oral solid preparations of generic chemical drugs approved for marketing before October 1, 2007 in the National Essential Drug List (2012 Edition), which is what we call the "289 Essential Drug List", before the end of 2018 To complete the consistency evaluation, if it is not completed within the time limit, no further registration will be granted.

According to Cyber Blue statistics, as of today, there are 139 products that have passed or deemed to have passed the consistency evaluation. Among them, there are only 50 products belonging to the "289 Basic Drug List", involving 21 varieties.

Previously, industry experts once stated to Cyberland that, based on the current status of passing varieties in the consistency evaluation, the consistency evaluation of the "289 Catalog" is limited and it is likely to be postponed.

Now everyone finally got what they wanted, and the postponement came.

The deadline is still there, and the cancellation approval document has not been completed after the deadline

Although we can confirm that the year-end expiration date of the "289 Essential Medicines List" has been cancelled, it must be noted that the expiration date is still there.

According to the policy interpretation of the “Announcement on the Quality and Efficacy Consistency Evaluation of Generic Drugs” issued by the State Food and Drug Administration, the time limit for the consistency evaluation of the “289 Basic Drug List” is the same as the previous approval for the listing of chemical drugs before the implementation of the new registration classification. The requirements of other generic drugs are the same, that is: "After the first product has passed the consistency evaluation, the same product of other drug manufacturers should in principle complete the evaluation within 3 years."

In addition, the State Food and Drug Administration has made it clear that, taking into account the regional and timeliness of clinical demand for drugs, in order to ensure market supply and the people’s access to drugs, companies that fail to complete the evaluation in accordance with the above requirements are deemed to be clinically necessary after evaluation. For varieties that are in short supply in the market, an application for postponement of evaluation can be submitted to the local provincial drug regulatory authority, explaining the reasons and providing an evaluation report. The provincial drug regulatory authority and the health administrative department will organize research and demonstration, and the products identified as clinically necessary and market-shortened , Can be extended appropriately, in principle, not more than 5 years.

At the same time, the provincial drug regulatory authority, in conjunction with relevant departments, shall continue to guide, supervise and support the evaluation work of enterprises for the varieties that have agreed to the extension. If it has not been completed by then, the drug regulatory authority shall not approve the drug re-registration application.

If the company fails to complete the consistency evaluation on time and does not apply for extension of generic drugs including essential drugs, the State Food and Drug Administration has made it clear that such varieties will not be re-registered and the approval number will be cancelled.

There is no time limit for the 2018 edition of the basic drug varieties

The State Food and Drug Administration has made it clear that for the varieties included in the National Essential Drug List, there is no longer a uniform time limit for evaluation.

There are two reasons:

First, the consistency evaluation of the essential medicines and the dynamic adjustment of the essential medicines catalog are promoted in conjunction. The "National Essential Medicines List (2018 Edition)" was implemented on November 1, 2018. Major adjustments have been made to the old version of the catalog. The essential medicines catalog has established a dynamic adjustment mechanism, and the varieties that have passed the consistency evaluation are given priority to be included in the catalog. The varieties that pass the consistency evaluation will be gradually brought out of the catalog.

Second, in the process of comprehensive advancement of consistency evaluation in our country, we are faced with many challenges such as improving scientific understanding, selection of reference preparations, determination of evaluation methods, and insufficient resources for clinical trials. The technical problems found in it need to be scientifically evaluated and gradually solved.

Essential drugs are the focus of the consistency evaluation work and are of great significance for ensuring the public use of drugs. Among the basic drug varieties, about 180 varieties are low-priced drugs, such as dapsone tablets, dexamethasone tablets, mercaptopurine tablets, etc., some of which are clinically necessary and are in short supply in the market. Ensuring the availability of essential medicines is related to the basic needs of the public for clinical medicine, and requires the active cooperation of the consistency evaluation policy and corresponding adjustments.

Since the consistency evaluation work of essential medicines has been advanced in conjunction with the dynamic adjustment of the essential medicines catalog, there is no longer a separate time limit for the evaluation of essential medicines.

Attachment: Announcement of the State Drug Administration on Matters Concerning the Quality and Efficacy Consistency Evaluation of Generic Drugs (No. 102 of 2018)

In recent years, all relevant departments have conscientiously implemented the "Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices" (Guo Fa [2015] No. 44) and the "Opinions of the General Office of the State Council on Carrying out the Quality and Efficacy Consistency Evaluation of Generic Drugs" (Guobanfa [2016] No. 8) and other regulations, take practical and effective measures to promote consistency evaluation; companies continue to increase R&D investment and actively carry out evaluations. In order to further improve the consistency evaluation work, with the approval of the State Council, the relevant matters are hereby announced as follows:

1. Strict evaluation standards and strengthen post-listing supervision

Strict consistency evaluation, review and approval, adhere to the review principle of consistent quality and efficacy of generic drugs and original research drugs, adhere to the standard not to be lowered, and carry out technical reviews in accordance with the published guidelines for relevant drug development technologies. Strengthen the post-market supervision and inspection of drugs, and the drugs that have passed the consistency evaluation will be included in the next year's national drug sampling plan, and the supervision and inspection of relevant enterprises will be strengthened.

2. Time obeys quality, and reasonably adjust related work time limits and requirements

(1) The "National Essential Drug List (2018 Edition)" has been implemented on November 1, 2018, and a dynamic adjustment mechanism has been established to achieve linkage with consistency evaluation. The varieties that pass the consistency evaluation will be included in the catalog first, and the varieties that have not passed the consistency evaluation will be gradually transferred out of the catalog. For the varieties included in the national essential medicines list, the time limit for evaluation will no longer be set uniformly.

(2) For generic drugs including essential drug varieties approved for marketing before the implementation of the new registration classification of chemical drugs, after the first variety has passed the consistency evaluation, the consistency evaluation of the same varieties of other drug manufacturers should, in principle, be completed within 3 years . If the product is not completed within the time limit, the enterprise may submit an application for extension of evaluation to the local provincial drug regulatory authority if it is assessed that it is clinically necessary and the market is in short supply. After the provincial drug regulatory authority and the health administrative department organize research and identification, the extension may be appropriately extended . If the application is not completed within the time limit, no further registration shall be granted.

3. Strengthen service guidance and make every effort to promote consistency evaluation

In-depth implementation of the State Council’s reform requirements of “delegating management and service”, insisting on giving equal attention to guidance, supervision and service, according to the specific conditions of the evaluation varieties, classify and implement separate policies, and further strengthen service guidance. Establish a green channel, and follow-up review of applications for consistency evaluation to speed up the review process. If an enterprise encounters a major technical problem during the research process, it can communicate with the drug review agency in accordance with the relevant provisions of the "Administrative Measures on Communication and Communication for Drug R&D and Technical Review." Further strengthen the guidance to key varieties and key enterprises, organize on-site investigation and communication, and help enterprises solve difficult problems.

4. Strengthen supporting policy support and mobilize the enthusiasm of enterprise evaluation

Give full play to the role of the market mechanism and stimulate the enthusiasm of enterprises to carry out consistency evaluation. For products that have passed the consistency evaluation, the drug regulatory authority allows them to be marked on the insert sheet and label, and included in the "China Listed Drug Catalogue"; for the same variety of drugs that have passed the consistency evaluation of more than 3 drug manufacturers In terms of centralized drug procurement, in principle, products that have not passed the consistency evaluation will no longer be selected. On the basis of ensuring the quality and supply of medicines, all localities should improve the centralized procurement policy based on actual conditions; the National Health Commission will support the low-priced and clinically necessary drugs in the "National Essential Drug List (2018 Edition)" in supporting policies. Guarantee the demand for clinical medication.

Special announcement.

National Food and Drug Administration

December 28, 2018