Provisions for Post-approval Changes of Drugs (Interim)

Chapter III Confirmation and Adjustment of Change Management Categories

Article 20 Where the change management category of circumstances of change has been specified in laws, regulations or technical guidelines, MAHs shall generally determine the change management category in accordance with relevant provisions.

Where the change management category of circumstances of change has not been specified in laws, regulations or technical guidelines, MAHs shall determine the change management category on the basis of sufficient study, evaluation and necessary verification according to the internal change classification principle, working procedures and risk management criteria, by referring to relevant technical guidelines in combination with product characteristics.

Article 21 Where domestic MAHs are unable to determine the change management category on the basis of sufficient study, evaluation and necessary verification, it may communicate with the provincial drug regulatory department, which shall give a written reply within 20 days and implement it as required if agreement are reached; where the opinions on whether the change belongs to the review and approval type are not agreed, MAHs shall submit a supplementary application to CDE as per the review and approval category; where the opinions on whether the change belongs to the filing or the report type are not agreed, MAHs shall notify the provincial drug regulatory department as per the filing category change. The specific communication procedure shall be developed by each provincial drug regulatory department.

Where the overseas MAHs fail to confirm the change management category based on sufficient study, evaluation and necessary verification, it may communicate with CDE, and the specific communication procedure shall be subject to the relevant procedure for communication of drug registration.

Article 22 MAHs may adjust the change management category according to the management and production technology changes, and implement the change as per the adjusted change management category upon approval or filing, or report.

Where the change management category specified in the technical guidelines is to be lowered, or the change management category in the list of MAHs changes is to be lowered, the domestic MAH shall, on the basis of sufficient study, evaluation and necessary verification, communicate with the provincial drug regulatory department which shall give a written reply within 20 days, and implement it as required for those reached agreement, and the change management category shall not be lowered if agreements are not reached. The specific communication procedure shall be developed by each provincial drug regulatory department.

Where the change management category of overseas drugs is to be lowered, MAHs shall implement it after communicating with CDE and reaching an agreement on the basis of sufficient study, evaluation and necessary verification. Where the agreements are not reached, the change management category shall not be lowered. The specific communication procedure shall be subject to the relevant procedure for communication of drug registration.

Article 23 Before the implementation of the newly revised Drug Administration Law and the Provisions for Drug Registration, for the implemented changes that have been proven by the MAH or manufacturer to have no effect on the drug quality through study and verification in accordance with the relevant provisions and technical requirements for the management of changes in the original production process, or for the processes that have been confirmed in the approval and renewal, it is not necessary to make re-application in accordance with the new provisions and technical requirements for the change management. Where changes occur again, they shall be implemented in accordance with the current provisions and technical requirements for the change management and included in drug product master file.