In order to meet the clinical needs of patients and ensure the safety, effectiveness and controllable quality of drugs, applicants are encouraged to select the varieties included in the catalog of reference preparations published by the national drug regulatory authorities for generic research. For varieties not included in the catalog of reference preparations, i.e., varieties without reference preparations, the applicant may carry out generic research if there is expected clinical value after evaluation. The relevant requirements for the research on the imitation of non-reference preparation varieties are hereby announced as follows:
1. Adhere to high standards and strict requirements. Problem-oriented, deepen the reform of the drug review and approval system, and carry out relevant work in accordance with the principle of providing high-quality generic drugs to the public and promoting the high-quality development of the generic drug industry.
2. Adhere to the guidance of clinical value. The generic varieties should be in line with the current scientific understanding and clinical diagnosis and treatment needs and practices, be widely used as mainstream drugs, and have irreplaceable characteristics, and have sufficient clinical trial data to support that the clinical benefits outweigh the risks. The applicant should fully evaluate the expected clinical value of the proposed product and prove its expected clinical value through well-designed clinical trials.
3. Adhere to the most rigorous standards and improve product quality. The applicant should carry out generic research based on the current technical requirements, and carry out a comprehensive quality assessment of the drugs of the same variety that have been marketed. The quality of generic drugs is not lower than that of marketed varieties that are fully researched, have a good marketing foundation or have a large market share in the corresponding disease field.
4. On the basis of fully evaluating the expected clinical value of the non-reference preparation, the applicant shall submit an application for communication and exchange (Class III) to the Center for Drug Evaluation of the State Food and Drug Administration (hereinafter referred to as the Drug Evaluation Center) and submit relevant research data if it intends to imitate. The drug review center shall organize experts and applicants to communicate on the expected clinical value of the drug within the specified time, and the results of the communication shall be provided for the applicant’s reference and disclosed in an appropriate form. If there are no special circumstances for the same varieties in the future, you can refer to the published communication results.
5. For varieties that have been preliminarily judged to have expected clinical value, after the applicant completes the relevant research, the applicant shall submit a clinical trial application in accordance with the current clinical trial application procedures, and the results of communication and exchange will be fully referred to in the review process of the clinical trial application. After the completion of the clinical study, the applicant shall submit a marketing application with reference to the current generic drug registration classification. The drug review center shall review the generic drug application in strict accordance with the current technical requirements, and approve the application if the quality meets the requirements and there is sufficient evidence to support its clinical value.
6. After the generic drugs of non-reference preparations for clinical research are approved for marketing, they will be included in the “Catalogue of Chemical Drugs Newly Approved for Marketing and Approved for Consistency Evaluation of the Quality and Efficacy of Generic Drugs”. Listed generic drugs without reference preparations do not belong to the scope of consistency evaluation, and the relevant policies of consistency evaluation do not apply after the approval of the relevant supplementary application.
7. This announcement shall be implemented from the date of promulgation. In the event of any inconsistency between the previous provisions and this announcement, this announcement shall prevail.
The announcement is hereby made.
Attachment: Policy interpretation of the announcement of the State Food and Drug Administration on the research on the imitation of non-reference preparations
State Food and Drug Administration
October 12, 2023
