Shanxi and Sichuan provinces publicly solicit opinions on the implementation rules for post-marketing drug changes

On August 12, the Shanxi Provincial Drug Administration released its opinions on the "Implementation Rules for the Administration of Post-Market Modification Recording (Trial)" (Draft for Solicitation of Comments)

The original text is as follows:

In order to implement the "Drug Administration Law", "Vaccine Administration Law", "Drug Registration Management Measures" and "Drug Post-Marketing Change Management Measures (Trial)" and other regulations on the management of post-marketing drug changes, strengthen post-market change management and standardize After the drug is marketed, the Provincial Food and Drug Administration has organized and drafted the "Implementation Rules for the Administration of Post-Market Change Recording (Trial) (Draft for Solicitation of Comments)", which has been publicly solicited from the public on the website of the Provincial Food and Drug Administration on February 26, 2021.

The original policy interpretation is as follows:

1.

On January 12, 2021, the State Food and Drug Administration issued the "Administrative Measures for Post-Marketing Changes of Drugs (Trial)" (hereinafter referred to as the "Measures"), which clearly requires the provincial drug regulatory authorities to refine relevant filing review requirements and formulate provincial registration management The specific working procedures and requirements for the record management of item changes; meanwhile, each provincial drug regulatory authority is required to formulate specific communication procedures on its own

2.

Article 2 of the "Implementation Rules" clearly stipulates the scope of application of drug listing changes: First, the holders of our province apply for drug registration changes and drug production site changes after drug marketing, mainly including drug approval document management information changes, drug production process the moderate change, changes and other pharmaceutical production sites

3.

First, as an important part of the post-marketing change management of drugs, the drug insert sheet and label change filing shall be formulated in the "Implementation Rules", and the regulatory innovation measures will be launched to serve the holders

4.

Laws, regulations and related technical guidelines clearly belong to major changes approved by the State Food and Drug Administration, minor changes reported by the holder, and changes confirmed by the holder after communication with the Provincial Food and Drug Administration that they do not belong to the record category, None of them belong to the scope of post-marketing drug filing changes implemented by the provincial drug regulatory authorities

Prior to the implementation of the newly revised "Drug Administration Law" and "Drug Registration Management Measures", the holders have undergone research and verification in accordance with the relevant regulations and technical requirements of the original production process change management to prove that the implemented changes do not affect the quality of the drug, or have been approved, The process confirmed in the re-registration does not need to be re-declared in accordance with the new change management regulations and technical requirements

5.

(1) Circumstances and declaration of changes to the drug production site

(2) Requirements for changes in drug production sites and associated changes

6.

Before the implementation of the "Measures", if the holder or the drug manufacturer has completed the change of the production address information of the "Drug Production License" and still needs to change the drug production site specified in the drug registration approval document and its annex, the "Implementation Rules" 》It is clearly stipulated that the “Domestic Production Drug Recording Category” change declaration can be made through the Drug Business Application System of the Online Office of the State Drug Administration, and the filing materials can be submitted online

7.
What should the holder do if there is a change in drug registration items before the drug is re-registered or before the long-term unproduced product is resuming production?

If a drug registration item is changed before the re-registration of the drug or before the resumption of production of a long-term unproduced product, the holder shall complete the research and verification of the change before the re-registration application for the drug or before the resumption of production, and approve, record or report according to the corresponding category
.
If the drug cannot be completed on time due to actual conditions before the re-registration of the drug, the reasons shall be fully explained, and the provincial bureau shall indicate “the drug is changed at the same time (production site, drug prescription, production process, quality standard, etc.
) changes at the time of re-registration approval.
Only after approval or filing is completed can it be produced and put on the market"
.

8.
What are the high-risk varieties? What kinds of special injections are referred to?

Means high risk species vaccines, blood products, biological products, biochemical multi-component, for large volume injections of the drug, medicine injection, injection special, specific medicines
.

Special injection means that compared with ordinary injections, the quality of special injections and the in vivo behavior of their active ingredients are more affected by the prescription and process, which may further affect the safety and effectiveness of the preparation in the body, such as liposomes, intravenous milk microspheres, injectable suspension, oil solution, micelle
.

9.
When a drug is changed after the market is on the market, when a record-related and report-related change occurs at the same time, how should it be reported?

If the registration and reporting related changes of the drug occur at the same time, or when the reporting change is based on the completion of the filing change, the holder can combine the filing and reporting changes to submit a filing application, and the corresponding research data should generally be based on the technical The more demanding categories of changes are made
.
The holder can also file for the record-type changes separately, and then manage the report-type changes in accordance with relevant regulations after completion
.

For non-related filing and reporting changes, in principle, they should be filed or reported separately in accordance with regulations
.

10.
If the application for the change of the drug production site involves the re-registration of a drug that has not been produced for a long time, how to handle it?

If the application for the change of the drug production site involves the re-registration of a drug that has not been produced for a long time, the holder or the drug manufacturer shall simultaneously submit the application for the change of the drug production site and the application for the resumption of production, and the inspection and inspection of the resumption of production shall be implemented simultaneously with the change of the production site
.

11.
How to deal with changes in pharmaceutical excipients and pharmaceutical packaging materials?

The "Implementation Rules" clearly stipulates the principle of change of pharmaceutical excipients and pharmaceutical packaging materials
.
When the medicinal excipients and packaging materials that have passed the review and approval are changed, the registrant of the medicinal excipients and packaging materials shall take the initiative to carry out research and manage in strict accordance with relevant national requirements to ensure product quality, medicinal excipients and packaging materials The changes should be updated on the registration platform in a timely manner, and summarized in the previous year’s annual report submitted in the first quarter of each year
.

When the pharmaceutical excipients and packaging materials are changed and before the change is implemented, the relevant pharmaceutical preparation holders shall be notified in time.
The preparation holders shall be responsible for the quality of the selected pharmaceutical excipients and pharmaceutical packaging materials, and the preparation holders shall receive the above notification Afterwards, the corresponding changes shall promptly evaluate or study the risk conditions affecting the quality of pharmaceutical preparations, and submit supplementary applications, filings or reports in accordance with relevant regulations
.

If the pharmaceutical excipients and packaging materials that have not passed the review and approval and have not yet entered the review process are changed, the registrant of the pharmaceutical excipients and packaging materials can update the relevant information at any time through the registration platform of the Center for Drug Evaluation
.

On August 11, the Sichuan Provincial Food and Drug Administration publicly solicited the "Detailed Rules for the Management of Post-marketing Drugs in Sichuan Province (Draft for Public Comment)
.
"

The original text is as follows:

In order to implement the "Drug Administration Law", "Measures for the Administration of Drug Registration" and "Measures for the Administration of Post-Marketing Changes (Trial)" and other regulations on the management of post-marketing changes to drugs, strengthen post-marketing change management and standardize post-marketing change behaviors , Sichuan Provincial Drug Administration organized the drafting of the "Detailed Rules for the Management of Post-marketing Drugs in Sichuan Province (Draft for Public Comment)", which is now open to the public for comments
.
Please send your comments to 232456903@qq.
com by email before August 19, and the subject of the email should indicate "Feedback on Implementation Rules for Change Management"
.