I. What requirements does the Provisions set forth for the safety management of experimental research involving narcotic drugs and psychotropic substances (hereinafter referred to as narcotic and psychotropic drugs)?

To strengthen the safety management of experimental research involving narcotic and psychotropic drugs, the Provisions propose requirements from multiple aspects, including safety management systems and facilities and equipment, entrusted research management, management of experimental researchers, and management of narcotic and psychotropic drugs and active substances. For example, the approval holder is required to assess the research capability and the safety management capability regarding narcotic and psychotropic drugs of third-party institutions entrusted to conduct research; the approval holder and co-development entities are required to strictly manage the active substances generated during experimental research. The approval holder and co-development entities should manage the entire experimental research process in accordance with the Provisions to prevent narcotic and psychotropic drugs, active substances, and related synthesis technologies from flowing into illegal channels.

II. The Provisions require that the approval holder and co-development entities complete the research within the validity period of the experimental research project approval for narcotic and psychotropic drugs and submit a drug registration application. How should "drug registration application" be understood?

"Drug registration application" refers to submitting an application for drug clinical trials (or completing the bioequivalence trial filing) in accordance with statutory procedures and relevant requirements; for drugs meeting the conditions for exemption from clinical trials, it refers to submitting an application for marketing authorization.

III. How should experimental research project approvals obtained prior to the implementation of the Provisions be managed?

 The Provisions extend the validity period of experimental research project approvals from 3 years to 5 years, and except for innovative drugs, approvals for other varieties are generally not subject to extension. For approvals obtained prior to the implementation of the Provisions and still within their validity period, the approval holder may apply for a one-time extension. The National Medical Products Administration (NMPA) will decide whether to approve the extension in accordance with prescribed procedures, considering the progress of experimental research and other factors.

IV. How should "varieties not yet listed in the narcotic drugs and psychotropic substances catalog but with dependence potential" be understood?

It refers to varieties indicated in relevant literature as having dependence potential, varieties already controlled as narcotic and psychotropic drugs overseas, varieties structurally similar or sharing the same targets as narcotic and psychotropic drugs, and varieties demonstrating dependence in animal experiments.

If dependence is discovered during clinical trials of the studied variety, the approval holder should promptly submit a project application for experimental research.

V. Under what special circumstances should an experimental research application be submitted for varieties newly listed in the catalog of the narcotic and psychotropic drugs?

From the date on which the national announcement adjusting the catalog of narcotic and psychotropic drugs is issued, entities that have already initiated experimental research involving newly listed varieties, obtained approval to conduct clinical trials (or completed the filing for bioequivalence trials), or whose product is undergoing drug registration review and approval but has not yet received a marketing authorization for the relevant variety, should promptly submit an experimental research project application for the variety in accordance with the Provisions.

VI. How is the term "Principal Investigator" defined in the Provisions?

"Principal Investigator" refers to researchers who possess knowledge of the preparation methods of the experimental research variety, as well as the persons in charge of the respective levels of research work for the variety.

VII. How should "corresponding or higher level of control" be understood?

The Provisions specify that the levels of control over narcotic and psychotropic drugs, from highest to lowest, are ranked as narcotic drugs, Class I psychotropic substances, and Class II psychotropic substances. For experimental research on varieties other than innovative drugs, at least one of the applicant or co-development entities should be a designated manufacturer holding the corresponding control level or a higher control level qualification for the proposed research variety. For example, if the proposed research variety is a Class II psychotropic substance, at least one enterprise among the applicant or co-development entities should have obtained designated manufacturing qualification for Class II psychotropic substances, or at least one enterprise should hold designated manufacturing qualification for Class I psychotropic substances, or at least one enterprise should hold designated manufacturing qualification for narcotic drugs; if the proposed research variety is a Class I psychotropic substance, at least one enterprise among the applicant or co-development entities should have obtained designated manufacturing qualification for Class I psychotropic substances, or at least one enterprise should have designated manufacturing qualification for narcotic drugs; if the proposed research variety is a narcotic drug, at least one enterprise among the applicant or co-development entities should have obtained designated manufacturing qualification for narcotic drugs.

VIII. What is the difference between co-development entities and entrusted third-party institutions?

Co-development entities refer to enterprises or drug R&D institutions that jointly submit the narcotic and psychotropic drugs experimental research project application with the applicant and conduct experimental research. If the approval holder intends to conduct experimental research jointly with other enterprises or drug R&D institutions, an application to add co-development entities should be submitted to the NMPA, and joint research may proceed only after approval; if the approval holder intends to change co-development entities, an application should also be submitted to the NMPA.

The entrusted third-party institutions refer to institutions with corresponding qualifications entrusted by the approval holder to carry out specific testing items or pharmacological and toxicological studies, particularly those involving high-cost and low-frequency use of specialized analytical equipment. The approval holder should supervise the entrusted third-party institutions.