Xinjiang releases an announcement on the communication and communication procedures for the change management category of drugs after the listing

On August 13, the Drug Administration of Xinjiang Uygur Autonomous Region issued an announcement on the “Working Procedures for Communication and Exchange of Post-marketing Drugs in Xinjiang Uygur Autonomous Region (Trial)”

The original text is as follows:

In order to further deepen the reform of “delegation, regulation and service”, to meet the needs of drug marketing license holders in our district (including drug substance registrants, hereinafter referred to as holders) for the determination of drug categories after marketing, regulate the holders and our drugs Post-marketing change management category communication, according to the "Drug Registration Management Measures", "Drug Production Supervision and Management Measures", "Post-marketing Change Management Measures (Trial)" and other laws and regulations, our bureau formulated the "Xinjiang Uygur Autonomous Region Drugs Post-Marketing Change" Management Category Communication Work Procedures (for Trial Implementation)," is hereby announced

Post-marketing drug change management in Xinjiang Uygur Autonomous Region

Category Communication Working Procedures (Trial)

In order to strengthen the management of post-marketing drug changes in our region, standardize drug marketing license holders (including API registrants, hereinafter referred to as holders) and Xinjiang Uygur Autonomous Region Drug Administration (hereinafter referred to as the district bureau) to change the management categories of drugs after listing In accordance with the "Measures for the Administration of Drug Registration", "Measures for the Supervision and Administration of Drug Production", "Measures for the Administration of Post-Market Changes (Trial)" and other laws and regulations, this procedure is formulated

1.

If a drug is changed after it is marketed in one of the following circumstances, the holder may apply to the district bureau for communication:

(1) Laws, regulations, rules or technical guidelines do not specify the type of change management, and the holder is unable to determine the type of change management based on sufficient research, evaluation and necessary verification;

(2) Reduce the types of change management specified in the technical guidelines;

(3) Lower the change management category in the holder's change list

2.

(1) Proposal of communication

The holder shall put forward self-assessment opinions on relevant change categories, and those who intend to participate in the communication shall be familiar with relevant technical regulations, and have the experience and ability to exchange and discuss professional issues

(2) Preparation for communication

According to the complexity of the change, the registration and management office of the district bureau and the holder jointly agree on the form of communication

If it is necessary to hold a communication meeting, discuss with the holder the relevant matters of the meeting and confirm the time, place, agenda and other information

(3) Implementation of communication

(4) Postponement or cancellation of communication meetings

If it is determined that the communication and exchange will be implemented in the form of a meeting, the meeting will be cancelled if one of the following situations exists: the holder proposes to cancel the meeting; the holder’s problem has been resolved or has been replied through other communication methods

3.

(1) In accordance with the "Measures for the Administration of Post-Market Changes (Trial)" and other relevant regulations, the holders communicate with the district bureau, and if they agree, they should submit supplementary applications, filings or reports in accordance with the change procedures

(2) If there is a disagreement on whether the change is in the approval category, the holder shall submit a supplementary application to the Drug Evaluation Center of the State Drug Administration in accordance with the approval category change
.

(3) If there is a disagreement on whether it belongs to the record-type change and the report-type change, the holder shall file with the district bureau in accordance with the record-type change
.

Attachment: 1.
Communication application form

2.
Communicate and exchange application materials

3.
Communication and feedback form