NEW CHANGE! In these cases of post-listing changes, please cancel the filing in time

The author has compiled the latest developments in the recent post-listing change supporting policies of various provincial bureaus in the pharmaceutical industry, one of the very important news is: on November 17, 2022, the Shandong Provincial Drug Administration issued the "Notice on Public Solicitation of Opinions on the Implementation Rules for the Administration of Post-marketing Changes to Drugs in Shandong Province", the most important of which is the addition of Article 8 to cancel the filing
.
The author summarizes and analyzes the supporting policies of the post-listing change implementation rules issued by various provincial and municipal bureaus in China as of November 20, 2022, so as to facilitate the understanding and application
of change control personnel.

1.
The release of supporting documents related to the implementation rules of the changes after the listing of provincial bureaus across the country

In order to facilitate pharmaceutical people, especially registrants, to easily access the province's relevant post-marketing change management policies at any time, the author has summarized the list of supporting policies as of November 20, 2022, if there is any omission, welcome to add, 15 policies and regulations have been released, 14 have been officially implemented, and 1 is in the draft for comments, yellow shading indication
.

2.
Focus on the implementation rules for the filing of post-marketing changes in drugs

On January 12, 2021, the State Food and Drug Administration issued the Administrative Measures for Post-Market Changes of Drugs (Trial), which further clarified the basic procedures for record-filing changes, and required provincial drug regulatory authorities to formulate specific procedures and detailed review requirements for the management of recordal changes, on March 12, 2021, the Shandong Provincial Food and Drug Administration issued the "Implementation Rules for the Administration of Post-marketing Changes to Drugs in Shandong Province (Trial)", which is the first after the issuance of the State Food and Drug Administration's Administrative Measures for Post-Market Changes (Trial).
On November 17, 2022, the Shandong Provincial Drug Administration organized the "Implementation Rules for the Administration of Post-marketing Changes in Shandong Province" to sort out and adjust the "Implementation Rules for the Administration of Post-marketing Changes in Shandong Province", and the author sorted out and shared several hot issues
in the implementation rules for the management of post-marketing changes for the recordation.

1.
What circumstances need to cancel the filing after the drug is changed after marketing

If the filing matters proposed by the holder fall under any of the following circumstances, the filing shall be cancelled and the holder shall be informed:

1) Situation 1: The category of change management is improperly classified;

2) Situation 2: The on-site verification is not passed;

3) Situation 3: The registration inspection results do not meet the regulations;

4) Scenario 4: The research materials submitted by the holder are insufficient to prove that the change is scientific, reasonable and risk-controllable;

5) Situation 5: The holder fails to submit corrective materials without justifiable reasons within the prescribed time limit;

6) Scenario 6: The holder withdraws on its own initiative;

7) Situation 7: Other circumstances
that do not meet the filing requirements.

2.
What are the changes that the provincial bureau is responsible for after the drug is marketed?

Article 2 of the Implementation Rules for the Administration of Post-marketing Changes in Shandong Province (for Trial Implementation) clarifies
the scope of application of record-filing changes.

The first category is the post-marketing filing changes of drugs that are clearly defined by laws, regulations and relevant technical guidelines, and are implemented by the provincial drug regulatory authorities, mainly including medium changes in the drug production process, the filing of drug packaging label content, drug sub-packaging, and other changes
.

The second category is changes that are confirmed to be in the filing category after communication between the holder and the provincial bureau, and the written communication and exchange opinions of the provincial bureau that belong to the filing category should be provided, and the communication should be handled
in accordance with the working procedures for communication and exchange of the post-marketing change management category of drugs.

3.
Change the filing time limit requirements for each link of filing

According to the Implementation Rules for the Administration of Post-Market Change Filing of Drugs in Shandong Province (Trial), the filing procedure is divided into four links: filing application submission, receipt of filing materials, filing information publicity, and review of filing materials, and the Implementation Rules for the Administration of Post-marketing Change Filing of Drugs in Shandong Province (Trial) puts forward specific time limit requirements
for each link.

1) Time limit for filing information disclosure: For signed filing applications, the Shandong Food and Drug Evaluation and Inspection Center shall check and publicize the filing information within 5 working days from the date of receipt
.

2) Time limit for reviewing filing materials: Review of filing materials within 20 working days (on-site verification and sampling inspection time will not be counted into the review time limit).

3) Time limit for reviewing the filing materials: The Shandong Provincial Food and Drug Administration shall make a review conclusion
within 10 working days from the date of receiving the review opinion of the Provincial Review Center.

References

[1] Provincial Drug Administration websites, etc