NMPA's latest regulatory interpretation: Where will the transfer of pharmaceutical approvals go?

Guide: How to "live" the current lying not produced raw materials "approve"? 2020-07-31, the Comprehensive Division of the State Drug Administration publicly solicited the opinions of the Measures for the Administration of ChangeS After Drug Marketing (Trial) (Draft for Comments).
under the new regulations, how to transfer the preparation? Can API be transferred with approval supporting documents? 1 Changes in classified drugs after listing are divided into "regulatory changes" and "registration management changes".
this in itself is part of two different departments, the relevant working procedures are now combined in a management approach, the integration of the "Drug Registration Management Measures" and "Drug Production Supervision and Management Measures" and "post-marketing changes related to the provisions."
2 The relevant provisions on technology transfer shall be repealed from the date of publication, and the Notice on the Issue of the Regulations on the Registration and Administration of Drug Technology Transfer (No. 518 of 2009) and the Notice on matters related to the transfer of pharmaceutical technology in the process of implementing the new revised quality management norms for drug production shall be repealed.)
3 holders of the listing license of the "one drag two" model change management method simply clarified that "change" and "new" is not in fact contradictory.
not only "one drag two" can, "one drag more" can also be.
document indicates that the change of production units includes: changing the commissioned production units, increasing the entrusted production units, the holders of self-production changes to commissioned production, and entrusting production to self-production.
4 the original "commissioned production" to CDE application MAH "one drag more" although clearly can, but the document also pointed out that where the production unit changes (not the production site change, but the production subject change), the need to report to the pharmaceutical review center supplementary application, after approval and implementation.
can not help but make people's eyebrows, we call the "commissioned production", that is, the new commissioned production units.
shall now apply according to the following procedures: 1) complete the change of production license (the holder and the entrusted production unit); 2) complete the study in accordance with the requirements of the relevant technical guidelines for the change, submit a supplementary application to the drug review center, 3) the drug review center shall conduct a technical review within the prescribed time limit, organize on-site verification and sample extraction for inspection according to the review needs, and 4) withdraw the old certificate after approval and issue a new drug registration certificate.
MAH environment, the relevant regulations not only did not "relax" the new, change of production site approval, but more stringent than the original: originally under the provincial bureau management of the "drug commissioned production", now need to apply to the National Drug Review Center.
5 The transfer of holders of the constant production site for 20 working days is subject to the completion of the transferee's license changeand disapproval and a supplementary application to CDE that does not require a technical review, with a special time limit of 20 working days for such approval.
approval of such transfers, GMP compliance checks are also required.
but it's already very minimalist compared to other transfers of holders with production site changes.
6 The new requirements for transferee holders shall have a production quality management system that meets the requirements of the quality management practices for pharmaceutical production, and only after inspection can the drug be marketed for sale.
but gmp compliance checks are carried out on holders, other previous announcements or drafts for comments are not mentioned, and the Drug Listing Licensing Holders Inspection Procedure, which was consulted a few months ago, also examines more than GMP compliance checks. How does
7 preparations be transferred? According to the draft, if a Company A transfers a drug's license and production address to Enterprise B, how to apply? The transfer procedure can be deduced as follows: 1) the transfer either party completes the notarized transfer contract, 2) the transferee completes the change of production license, 3) applies to CDE for change of the holder's subject, 4) completes the relevant research, applies to CDE for a change of production unit, 5) after the approval is approved, withdraws the old certificate, changes the new drug registration certificate, and 6) passes the GMP compliance check.
this process compared with the original provincial bureau of the "one-stop" service, obviously some cumbersome. can isopharmaceuticals be transferred in
8 Ofita? The Measures for the Supervision and Administration of Drug Production stipulate that the raw materials approved or approved through the related review shall be produced on their own and shall not be entrusted to others for production.
this means that from the level of production supervision and management analysis, the production of API main body, is not subject to change.
, the supporting documents for the approval of API cannot be transferred.
, although the production site may make changes to the same address or different addresses in accordance with the latest draft of the chemical and pharmaceutical pharmacology guidelines, and changes to different addresses are only moderate, the nature of the "subject sdiffering" is changed.
simply, we can move from one production address to another production address, but both addresses have to be the same production unit, if the two addresses belong to two different production units, then belong to the API production enterprise change, is the production supervision and management measures are not allowed to occur.
how to "live" the current lying not produced raw materials "approve"? Several ideas that can be considered before: 1) the original production enterprise to the status of a technical service provider, the relevant technology of the product to another production enterprise re-declaration; 2) to achieve the "changed production enterprise belongs to the original production enterprise" conditions, 3) if the original production enterprise belongs to a group company, the company can achieve the same set of quality management system (which is the key), you can consider the re-declaration of the product, the group company as the main production, such as the production site changes in the future, the main production can be changed.
9 What changes can IED can apply for and how can I apply? (1) What changes can be applied for for by API: technical changes that are managed only by registered matters.
(2) what kind of API can apply for a change: the registration status of the associated review and approval platform is marked as "A" or the API that has been approved with the preparation and has been approved by the associated review.
(3) Who will make the change application: API registrant.
(4) How to make change applications: In accordance with the relevant provisions of the current drug registration management, technical guidelines and these provisions to determine the change category approved, after filing implementation or reporting, the relevant information shall be updated in time in the registration platform.
the relevant review and approval platform registration status marked as "A" or has been approved by the preparation one and through the associated review and approval of the API technical change, the API registrant shall, in accordance with the relevant provisions of the current drug registration management, technical guidelines and these provisions, determine the change category approved, implement editing or reporting, the relevant information shall be updated in time at the registration platform. After the
change is implemented, the API registrant shall notify the relevant holder of the change in a timely manner. After receiving the above notice, the holder of the
shall promptly evaluate or study the risk situation affecting the quality of pharmaceutical preparations by the corresponding changes, and submit a supplementary application, filing or reporting in accordance with the relevant provisions. Is the
10 degree of change fixed? No.
change of management category can not only be adjusted, but also this matter can also be discussed, not tied to the text, do not engage in "fundamentalism".
partly because the technical guidelines for change themselves do not exhaust all change situations, and partly because the holder is sometimes unable to determine the change management category and needs to communicate with the provincial bureau or CDE.
holders may adjust the change management category in accordance with changes in management and production technology and implement or report them in accordance with the adjusted change management category.
, reducing the specific change management categories in the technical guidelines should be implemented after communication and agreement with the drug regulatory authorities.
the proposed reduction of the management category for major changes, the provincial drug regulatory department shall transfer to the drug review center to assist in clarifying the change management category, and the drug review center shall reply within 30 days. What about the original certificate after the
11 change holder approves it? After the approval of the holder's change, the drug review center shall withdraw the original drug registration certificate, issue a new drug registration certificate, and make corresponding adjustments to the original production process, quality standards, instructions and information of the holder or production enterprise in the label or indicate in the approval conclusion, the drug approval number and the expiration date of the certificate shall remain unchanged.
attached: Holder change declaration and licensing procedures or follow-up work.