Provisions for Post-approval Changes of Drugs (Interim)

Chapter IV Procedures, Requirements, Supervision and Administration of Changes

Article 24 For the review and approval category, MAHs shall submit a supplementary application to CDE, submit the study data in accordance with relevant regulations and technical guidelines for change, and implement it after approval. The specific timeline shall be implemented in accordance with the relevant provisions of the Provisions for Drug Registration.

Article 25 MAHs shall promise the implementation time after the change is approved when submitting the supplementary application for change, and the implementation time in principle shall not exceed 6 months upon the date of change approval, except for the items involving drug safety change, which shall be subject to the implementation date specified in the Notice of Drug Supplementary Application.

Article 26 For filing category, MAHs shall notify CDE or provincial drug regulatory department. The authorities shall disclose the relevant information within 5 days upon the date of completion of filing.

Provincial drug regulatory departments shall strengthen the supervision and administration, complete the review on the notified materials within 30 days upon the completion of filing according to the risk characteristics and safety credit of the filing change items, and may carry out inspection and testing when necessary.

Provincial drug regulatory departments may detail relevant filing review requirements in accordance with the Provisions and other relevant regulations, and formulate specific working procedures and requirements for the filing management of changes of registration management items in respective provinces.

Article 27 The reporting category shall be managed by the MAHs in accordance with the relevant requirements for change management, which shall be indicated in the annual report.

Article 28 If the CDE and the provincial drug regulatory department consider that the supplementary application or filing for change received does not belong to their functions, they shall issue a written notification stamped with official seal to inform the applicant the reasons and relevant authorities to apply for the change.

Article 29 The NMPA shall establish a change application system to provide whole-process online services for the changes of filing and annual reporting categories.

Drug regulatory departments shall in a timely manner include the approval and filing of post-approval changes of drugs into drug product master file; MAHs shall summarize and analyze all the changes of drugs in this year into the annual report.

Article 30 The provincial drug regulatory department in the place where the MAHs and contract manufacturers are located shall strengthen the supervision and administration of post-approval changes of drugs in accordance with the relevant provisions for drug production supervision, supervise and inspect the MAHs' change control system, and urge them to fulfill their responsibilities for change management.

Where it is specified in laws, regulations and guidelines as a major change or determined by MAHs as a major change, it shall be implemented after being approved in accordance with relevant provisions. For the change to lower the category after communicating with and reaching an agreement with the drug regulatory department, the application for filing or reporting shall be filed according to the agreed category of change management. For the changes of filing and reporting categories specified in laws, regulations and technical guidelines or defined by MAHs, those shall be submitted in accordance with relevant provisions.

Article 31 Where the drug regulatory department finds that the study and verification results of the filing or reporting changes that have been implemented by the MAHs are insufficient to prove that the changes are scientific, reasonable and risk-controlled, or the category of the change management is incorrect, it shall require the MAHs to make correction and submit a new application according to the corrected management category, carry out risk assessment on the drugs that have been manufactured and marketed, and take corresponding risk control measures.

Where any major change is made in the drug production process without approval, or the change in the drug production process is not notified or reported in accordance with the provisions, it shall be handled in accordance with the relevant provisions of the Drug Administration Law.

Chapter V Supplementary Provisions

Article 32 Where there are special provisions for the management of changes in toxic drugs for medical use, narcotics, psychotropics, radio pharmaceuticals and biological products, such provisions shall prevail.

Article 33 The days specified in the Provisions shall be calculated in working days.

Article 34 The relevant requirements for the combined application of different supplementary applications shall be implemented in accordance with the relevant requirements of the Provisions for Drug Registration.

Article 35 The Provisions shall come into force on the date of issuance.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.