Provisions for Drug Registration

Section II Drug Marketing Authorization

Article 34 After having completed studies to support the drug marketing registration including CMC, pharmacological and toxicological studies and drug clinical trials, established the specifications and completed commercial-scale manufacturing process validation and preparation for drug registration inspection and testing, the applicant shall file a drug marketing authorization application and submit related study data as per application dossier requirements. The application shall be accepted when the application dossiers comply with requirements and pass the preliminary review.

Article 35 For generic drugs, in vitro diagnostic reagents managed as drugs and other eligible circumstances, where the applicant, upon assessment, considers that drug clinical trials are not needed or cannot be carried out and the conditions for waiving drug clinical trials are met, an application may be filed directly for drug marketing authorization. The technical guidelines and specific requirements for waiving drug clinical trials shall be formulated and published by the CDE.

Generic drugs shall be consistent in quality and efficacy with references. The applicant shall select a reasonable references as per relevant technical guidelines.

Article 36 Where any of the following conditions is met, the non-prescription drug marketing authorization application may be filed directly:

(1) Drugs with the same active ingredients, indications, dosage forms and strengths as non-prescription drugs that have been marketed within the territory of the People's Republic of China;

(2) Drugs developed by changing the dosage forms or strength of non-prescription drugs authorized by the NMPA without changing the indications, dosages or administration routes;

(3) New compound preparations composed of active ingredients of non-prescription drugs authorized by the NMPA;

(4) Other circumstances where marketing authorization for non-prescription drugs may be directly applied for.

Article 37 Where the adopted name to be used for a drug under application has not been included in the national drug standards or drug registration specifications, the applicant shall file the adopted name examination and approval application when submitting the drug marketing authorization application. After the drug marketing authorization application has been accepted, dossiers related to the adopted name examination and approval shall be forwarded to the CPC. After examination and approval, the CPC shall give feedback to the CDE.

Where the adopted name to be used for a drug under application has been included in the national drug standards or drug registration specifications, and the CDE, during review, considers it necessary to examine and approve the adopted name, the CPC shall be notified to examine and approve the adopted name and relevant information shall be provided. After examination and approval, the CPC shall give feedback to the CDE.

The CPC shall keep good communication with the applicant while examining the adopted name of drugs and inform the applicant of the approval results.

Article 38 The CDE shall organize CMC, medical and other technical personnel to evaluate accepted drug marketing authorization applications as required.

Where drug registration inspection and testing are initiated during review based on risks, relevant technical institutions shall complete inspection and testing within specified timelines.

The CDE shall conduct comprehensive review on the safety, efficacy and quality of drugs based on the drug registration application dossiers and inspection and testing results; for the non-prescription drug, the application shall be also forwarded to the CDR for the non-prescription drug eligibility review.

Article 39 If passing the comprehensive review, the drug shall be approved for marketing and a Drug Approval License shall be issued; if not, the drug shall be disapproved. The Drug Approval License shall bear the drug approval number, MAH, manufacturer and other information. The Drug Approval License for the non-prescription drug shall also indicate the non-prescription drug category.

The approved drug manufacturing process, specifications, package inserts and labels shall be issued to the applicant as attachments to the Drug Approval License, and the requirements for post-marketing studies shall be attached if necessary. The above information shall be included in the drug product master file and updated in time according to the changes after marketing.

After the drug is approved for marketing, the MAH shall manufacture the drug in accordance with the manufacturing process and specifications approved by NMPA, and follow the requirements of Good Manufacturing Practice (GMP) for specifics and implementation.

Article 40 Where major changes that may have an impact on the safety, efficacy and quality of a drug occur during the review period of a marketing authorization application, the applicant shall withdraw the registration application, carry out supplementary studies and then submit a new application.

Where changes that are not pertinent to the content of technical review occur, e.g., changes with the applicant's name or the registered address etc., the applicant shall promptly inform the CDE in written form and submit relevant documentary evidence.