How can I resolve any objection to the results of the drug registration review?

Introduction: The new version of the Drug Registration Review Conclusion Objection Resolution Procedure (Trial) was released! The new version of the objection resolution procedure is to better undertake the new "Drug Registration Management Measures", the content is consistent, and to refine and adjust the new version of the objection resolution procedures more time-called and operability, each link has clear specific working hours , expert advisory committee to participate in drug registration review objection resolution The role and status of the article has been highly valued , Yin Danni a sentence event September 1, 2020, the State Drug Administration issued the "Drug Registration Review Conclusion Objection Resolution Procedure (Trial)" (hereinafter referred to as the "Objection Resolution Procedure"), effective from the date of publication.
This is a supporting document issued in order to implement the newly revised Measures for the Administration of Drug Registration (hereinafter referred to as the Measures) and is also an official pilot document issued following the release of the Dispute Resolution Procedure for the Conclusions of Drug Registration Review (Draft for Comments) by the Drug Administration Drug Review Center in November 2019.
difference between the old and new objection resolution procedures? Regardless of the old and new versions of the objection resolution procedures, is to clarify the drug registration review to make a non-passed review conclusions, the registration applicant to file objections to the processing procedures.
seamlessly undertake the new "Drug Registration Management Measures" the new "Drug Registration Management Measures" focus on management functions, the provisions of the framework as the principle, for the follow-up supporting documents reserved "interface."
The "Drug Registration Review Conclusion Objection Resolution Procedure (Trial)" issued this time is to undertake the provisions of Article 90 of the new Measures, the specific provisions are consistent with the contents of the new Measures, and to make further refinement and adjustment.
In order to better link with the new Measures, the new Objection Resolution Procedure also combines the words "complaint" and "dispute" in the original draft into "objections", which are more accurate and reflect the authority of the IDR's review conclusions.
the new procedure is more time-called and operability than the draft for comments, the new Objection Resolution Procedure defines specific working hours for each aspect of objections, feedback and review.
process is more time-called, and the new "Drug Registration Management Measures" in line with the concept of time-limit control, aimed at optimizing the review and approval workflow, the good drug registration review and approval of the final pass, improve the predictability of registration time.
addition, the new Objection Resolution Procedure adds three annexes, namely, "Notice of The Review Conclusions Not Adopted", "Application Form for Objections to the Review of Drug Registration" and "Authorization Power of Attorney", and the operation is more standardized.
participation of the Expert Advisory Committee is noteworthy that the term "Expert Advisory Committee" has appeared 10 times in the new Objection Resolution Procedure, which shows that the Drug Administration has paid more attention to the role and status of the Expert Advisory Committee.
In the Objection Resolution Procedure, the main functions of the "Expert Advisory Committee" are: the conclusions of the review are based on the expert advisory committee;
Article 17 of the new Measures for the Administration of Drug Registration provides a summary of the "Expert Advisory Committee": "Professional and technical institutions such as the Drug Review Center shall establish an expert advisory system in accordance with the needs of their work, establish an expert advisory committee, listen to expert opinions on major issues in the course of review, verification, inspection and approval of common names, and give full play to the technical support role of experts."
as early as March 2017, the State Drug Administration issued the Measures for the Management of the Expert Advisory Committee on Drug Registration Review (Trial) and established the Expert Advisory Committee on Drug Registration Review to provide technical support and decision-making recommendations for drug registration review.
However, in the new Objection Resolution Procedure, the 2017 management approach did not appear, but rather the provision of "execution in accordance with the relevant provisions", the developer speculated that the follow-up will be in accordance with the new "Drug Registration Management Measures" to introduce a new expert advisory committee supporting documents.
References: 1. Announcement of the State Drug Administration on the Release of the Dissent Resolution Procedure (Trial) of the Drug Registration Review Conclusions (Trial) 2. Notice of the Drug Review Center of the State Drug Administration on the Public Request for Opinions on the Dispute Resolution Procedure for the Drug Registration Review Conclusions: National, Drug Registration 00.