Heavy! Official Announcement on Consistency Evaluation of Injection

Answer: In order to implement the work deployment of the State Council on accelerating the consistency evaluation of generic drugs, the General Drug Consistency Evaluation Office of the State Food and Drug Administration organized an expert committee to formulate a series of documents, such as "Technical Requirements for Quality and Efficacy Consistency Evaluation of Generic Chemical Injections", "Technical Requirements for Quality and Efficacy Consistency Evaluation of Generic Chemical Injections (Special Injections)", "Application Data Requirements for Quality and Efficacy Consistency Evaluation of Generic Chemical Injections" and other documents, which were released after extensive consultation, the quality and efficacy consistency evaluation of generic chemical injections was officially launched.

What are the objects of generic drug consistency evaluation for 2. chemical injections?

A: For generic chemical injections that have been listed, consistency evaluation is required for varieties that have not been approved in accordance with the principle of consistency with the quality and efficacy of the original drug. The drug marketing license holder shall select the reference preparation in accordance with the "Catalogue of Reference Preparations for Generic Drugs" issued by the State Drug Administration, and carry out the consistency evaluation research and development declaration.

For varieties that have not been included in the Catalogue of Reference Preparations for Generic Drugs, the drug marketing license holder shall declare the reference preparations in accordance with the provisions of the Announcement of the State Food and Drug Administration on Issuing the Procedures for Selection and Determination of Reference Preparations for Chemical Generic Drugs (No. 25 of 2019). After the reference preparations are determined, the consistency evaluation research and development declaration shall be carried out to avoid any discrepancy between the selection of the reference preparations and the reference preparations published by the state, research projects, resulting in waste of resources and other issues.

For chemical injection generic drugs with clear clinical value but unable to determine the reference preparation, such as sodium chloride injection, glucose injection, glucose and sodium chloride injection, water for injection, etc., such varieties do not need to carry out consistency evaluation. The generic drug consistency evaluation office of the State Food and Drug Administration will organize expert committees to sort out and release the catalogue of such varieties in stages and batches. Drug marketing license holders are encouraged to carry out research on drug quality improvement in accordance with the relevant guiding principles such as "Technical requirements for quality and efficacy consistency evaluation of generic drugs for chemical injections" and "Technical requirements for quality and efficacy consistency evaluation of generic drugs for chemical injections (special injections), and in accordance with the relevant provisions of the post-marketing change management of drugs to declare, the implementation of consistency evaluation of the review time limit.

What is the time requirement for the consistency evaluation of generic drugs for 3. chemical injections?

Answer: In accordance with the "Announcement of the State Drug Administration on Matters Concerning the Consistency Evaluation of the Quality and Efficacy of Generic Drugs (No. 102 of 2018)" and other relevant regulations.

What are the time limit requirements for the consistency evaluation and review of generic drugs for 4. chemical injections?

According to the Announcement on Matters Related to the Evaluation of the Quality and Efficacy Consistency of Generic Drugs (No. 100 of 2017), the review shall be completed within 120 days after acceptance. If the applicant's supplementary information is considered necessary after review, the applicant shall complete the supplementary information at one time within 4 months. The time limit for issuance of supplements shall not be included in the time limit for review.

5. varieties that have passed the consistency evaluation continue to enjoy relevant policy support?

Answer: For varieties that have passed the consistency evaluation, the drug regulatory authority allows them to be marked on the instructions and labels, and include them in the "Catalogue of Chemicals Newly Approved for Marketing and Passed the Quality and Efficacy Consistency Evaluation of Generic Drugs." Relevant departments will also provide policy support in accordance with the requirements of the "Opinions of the General Office of the State Council on Carrying out the Consistency Evaluation of the Quality and Efficacy of Generic Drugs" (Guo Ban Fa [2016] No. 8).