Provisions for Drug Registration

Chapter IV Accelerated Drug Marketing Registration Procedures

Section I Breakthrough Therapy Drug Procedure

Article 59 During clinical trials, for innovative drugs or modified new drugs used for the prevention and treatment of serious life-threatening diseases or diseases that seriously affect the quality of life but no effective means of prevention and treatment is available, or significantly clinically superior over current treatments with sufficient evidence is demonstrated, the applicant may apply for the breakthrough therapy drug procedure.

Article 60 Where the breakthrough therapy drug procedure is applicable, the applicant shall submit an application to the CDE. Applications that meet the requirements shall be included into the breakthrough therapy drug procedure by the CDE after going through the prescribed public disclosure process.

Article 61 For a drug clinical trial included into the breakthrough therapy drug procedure, the following support is offered:

(1) The applicant may, during key stages of the drug clinical trial, submit consultation and communication requests to the CDE, and the CDE shall assign reviewers for communication;

(2) The applicant may submit staged study data to the CDE, and the CDE shall, based on available study data, give comments or suggestions to the applicant on the study protocols for the next stage.

Article 62 Where a drug clinical trial included into the breakthrough therapy drug procedure no longer meets the inclusion conditions, the applicant shall promptly submit a request to the CDE to terminate the breakthrough therapy drug procedure. Where the CDE considers a trial no longer meets the inclusion conditions, the breakthrough therapy drug procedure for the product shall be promptly terminated, and the applicant shall be informed.

Section II Conditional Approval Procedure

Article 63 During the drug clinical trial process, drugs that meet the following conditions may apply for conditional approval:

(1) Drugs used for treating serious life-threatening diseases for which no effective treatment is available, whose efficacy has been verified by data in drug clinical trials and whose clinical values can be predicted; 

(2) Drugs that are urgently needed for public health, whose efficacy has been demonstrated by data in drug clinical trials and whose clinical values can be predicted;

(3) Vaccines urgently needed for response to critical public health emergencies or urgently needed as identified by the National Health Commission, whose benefits outweigh risks as evaluated.

Article 64 Where conditional approval is applied for, the applicant shall communicate with the CDE about the conditions for conditional marketing approval and the studies to be completed after marketing. Upon confirmation through consultation and communication, a drug marketing authorization application may be filed.

Where requirements for conditional approval are met upon review, the Drug Approval License shall specify the validity period of the conditional Drug Approval License, the post-approval studies to be completed, the timeline for completing post-approval studies and other relevant details.

Article 65 During review, where it is found that a drug registration application included into the conditional approval procedure does not meet the requirements for conditional approval, the CDE shall terminate the conditional approval procedure and inform the applicant to apply as per the normal review procedure.

Article 66 For a conditionally approved drug, the MAH shall take appropriate risk management measures after the drug is marketed and complete relevant studies including drug clinical trials as requested and submit supplementary applications within the specified timeline.

Where further studies are required when approval is given to a vaccine registration application, the vaccine MAH shall complete the studies within the specified period.

Article 67 For a conditionally approved drug, where the MAH fails to complete the studies as required within the specified timeline or fails to prove that the benefits outweigh risks, the NMPA shall handle the matter in accordance with the law until the Drug Approval License is revoked.

Section III Priority Review and Approval Procedure

Article 68 When filing for a drug marketing authorization application, the following drugs with significant clinical values may apply for the priority review and approval procedure:

(1) Drugs with urgent clinical needs in shortage, innovative drugs and modified new drugs for the prevention and treatment of major infectious diseases or rare diseases;

(2) New products, dosage forms and strengths of pediatric drugs complying with the physiological characteristics of children;

(3) Vaccines urgently needed for disease prevention and control, and innovative vaccines;

(4) Drugs included into the breakthrough therapy drug procedure;

(5) Drugs included into the conditional approval procedure;

(6) Other circumstances of priority review and approval specified by the NMPA.

Article 69 The applicant shall communicate with the CDE for confirmation prior to filing the drug marketing authorization application and then, when filing the drug marketing authorization application, submit a priority review and approval application to the CDE at the same time. Applications that meet the requirements shall be included into the priority review and approval procedure by the CDE after going through the prescribed public disclosure process.

Article 70 For a drug marketing authorization application included into the priority review and approval procedure, the following support is offered:

(1) The review timeline for drug marketing authorization applications is 130 days;

(2) For rare disease drugs with urgent clinical needs that have been marketed overseas but not marketed within the territory of the People’s Republic of China, the review timeline is 70 days;

(3) Where inspection, testing and approval of the adopted name are needed, priority will be given;

(4) Technical dossiers may be supplemented after confirmation through communication.

Article 71 During review, where it is found that a drug registration application included into the priority review and approval procedure does not meet the conditions for priority review and approval, the CDE shall terminate the priority review and approval procedure for the application, evaluate the application as per the normal review procedure and inform the applicant.

Section IV Special Review and Approval Procedure

Article 72 When a public health emergency breaks out, special review and approval for corresponding therapeutic and prophylactic drugs may be carried out based on the decision of NMPA in accordance with the law.

Article 73 For drug registration applications subject to special review and approval, the NMPA shall, following the principle of unified command, early intervention, rapid, efficient and scientific review and approval, accelerate and concurrently carry out drug registration acceptance, review, inspection and testing. The conditions, procedures, timeline and requirements for special review and approval are subject to the provisions of the Special Review and Approval Procedures for Drugs.

Article 74 For drugs included into the special review and approval procedure, their use may be restricted within prescribed time periods and scopes based on the specific needs for disease prevention and control.

Article 75 Where a drug included into the special review and approval procedure is considered to no longer meet the inclusion conditions, the special review and approval procedure for the drug shall be terminated, and the applicant shall be informed.