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On November 4, the Center for Drug Evaluation (CDE) of the State Food and Drug Administration (CDE) asked for comments on the "Management Regulations for the Suspension and Resumption of Review Timings in the Process of Drug Evaluation by the State Drug Administration (Trial) (Draft for Solicitation of Comments)" (hereinafter referred to as "Draft for Solicitation") Draft) Open for comments
.
The draft for comments proposes that one of the six cases of disapproval of publicity and dissent to the review conclusions will be suspended.
The time spent during the suspension shall not be included in the review time limit
.
The time limit for soliciting comments is two weeks from the date of publication of the draft for soliciting comments
.
.
The draft for comments proposes that one of the six cases of disapproval of publicity and dissent to the review conclusions will be suspended.
The time spent during the suspension shall not be included in the review time limit
.
The time limit for soliciting comments is two weeks from the date of publication of the draft for soliciting comments
.
According to the draft for comments, the six situations for the suspension of timing operations are: disapproval of publicity and dissent from the review conclusion; waiting for the company to reply and issue supplementary materials; waiting for an expert consultation meeting, etc.
; checking the production process, quality standards , and instructions And labeling; due to the applicant’s delay in verification, inspection, and rectification after verification, or initiation of overseas verification; circumstances in which the review process is suspended in accordance with laws, regulations , and rules
.
Among them, the circumstances in which the review procedure is suspended in accordance with laws, regulations, rules, etc.
, include situations in which the State Food and Drug Administration requires the suspension of the timing during the review process, situations in which the timing is suspended due to patent issues, situations in which the timing is suspended while waiting for supporting documents, and related Circumstances of suspension of timing of varieties and other circumstances
.
; checking the production process, quality standards , and instructions And labeling; due to the applicant’s delay in verification, inspection, and rectification after verification, or initiation of overseas verification; circumstances in which the review process is suspended in accordance with laws, regulations , and rules
.
Among them, the circumstances in which the review procedure is suspended in accordance with laws, regulations, rules, etc.
, include situations in which the State Food and Drug Administration requires the suspension of the timing during the review process, situations in which the timing is suspended due to patent issues, situations in which the timing is suspended while waiting for supporting documents, and related Circumstances of suspension of timing of varieties and other circumstances
.
The draft for comments detailed the specific operations of the suspension and resumption of timekeeping, classified in detail and made clear provisions on the suspension and resumption of timekeeping
.
For example, when the company responds to the relevant content of the supplementary materials, it is mentioned that during the related review process, one of the varieties needs to supplement the research data, and the other related variety cannot be reviewed separately, the review timing of the related variety should be suspended simultaneously.
The reason for the suspension is "Pending the company's reply to issue additional information"
.
The chief reviewer fills in the "Response to the supplementary information for the related variety*** (related variety acceptance number or registration number)" and announces it to the applicant, and the timing of this variety is automatically suspended
.
After all the species have been supplemented with the research materials, the task of related species will automatically resume timing
.
.
For example, when the company responds to the relevant content of the supplementary materials, it is mentioned that during the related review process, one of the varieties needs to supplement the research data, and the other related variety cannot be reviewed separately, the review timing of the related variety should be suspended simultaneously.
The reason for the suspension is "Pending the company's reply to issue additional information"
.
The chief reviewer fills in the "Response to the supplementary information for the related variety*** (related variety acceptance number or registration number)" and announces it to the applicant, and the timing of this variety is automatically suspended
.
After all the species have been supplemented with the research materials, the task of related species will automatically resume timing
.
The draft also defines related terms
.
During the review process, review timing management includes timing suspension and timing restoration
.
The suspension of review timing means that the review task of the drug registration application is suspended during the review process due to specific reasons, and the time used during the suspension is not included in the review time limit; the resumption of review timing means that the review task is suspended during the review time.
Later, when the specific reason for the suspension of the timing is eliminated, the timing shall be resumed
.
.
During the review process, review timing management includes timing suspension and timing restoration
.
The suspension of review timing means that the review task of the drug registration application is suspended during the review process due to specific reasons, and the time used during the suspension is not included in the review time limit; the resumption of review timing means that the review task is suspended during the review time.
Later, when the specific reason for the suspension of the timing is eliminated, the timing shall be resumed
.
On November 4, the Center for Drug Evaluation (CDE) of the State Food and Drug Administration (CDE) asked for comments on the "Management Regulations for the Suspension and Resumption of Review Timings in the Process of Drug Evaluation by the State Drug Administration (Trial) (Draft for Solicitation of Comments)" (hereinafter referred to as "Draft for Solicitation") Draft) Open for comments
.
The draft for comments proposes that one of the six cases of disapproval of publicity and dissent to the review conclusions will be suspended.
The time spent during the suspension shall not be included in the review time limit
.
The time limit for soliciting comments is two weeks from the date of publication of the draft for soliciting comments
.
.
The draft for comments proposes that one of the six cases of disapproval of publicity and dissent to the review conclusions will be suspended.
The time spent during the suspension shall not be included in the review time limit
.
The time limit for soliciting comments is two weeks from the date of publication of the draft for soliciting comments
.
According to the draft for comments, the six situations for the suspension of timing operations are: disapproval of publicity and dissent from the review conclusion; waiting for the company to reply and issue supplementary materials; waiting for an expert consultation meeting, etc.
; checking the production process, quality standards , and instructions And labeling; due to the applicant’s delay in verification, inspection, and rectification after verification, or initiation of overseas verification; circumstances in which the review process is suspended in accordance with laws, regulations , and rules
.
Among them, the circumstances in which the review procedure is suspended in accordance with laws, regulations, rules, etc.
, include situations in which the State Food and Drug Administration requires the suspension of the timing during the review process, situations in which the timing is suspended due to patent issues, situations in which the timing is suspended while waiting for supporting documents, and related Circumstances of suspension of timing of varieties and other circumstances
.
; checking the production process, quality standards , and instructions And labeling; due to the applicant’s delay in verification, inspection, and rectification after verification, or initiation of overseas verification; circumstances in which the review process is suspended in accordance with laws, regulations , and rules
.
Among them, the circumstances in which the review procedure is suspended in accordance with laws, regulations, rules, etc.
, include situations in which the State Food and Drug Administration requires the suspension of the timing during the review process, situations in which the timing is suspended due to patent issues, situations in which the timing is suspended while waiting for supporting documents, and related Circumstances of suspension of timing of varieties and other circumstances
.
The draft for comments detailed the specific operations of the suspension and resumption of timekeeping, classified in detail and made clear provisions on the suspension and resumption of timekeeping
.
For example, when the company responds to the relevant content of the supplementary materials, it is mentioned that during the related review process, one of the varieties needs to supplement the research data, and the other related variety cannot be reviewed separately, the review timing of the related variety should be suspended simultaneously.
The reason for the suspension is "Pending the company's reply to issue additional information"
.
The chief reviewer fills in the "Response to the supplementary information for the related variety*** (related variety acceptance number or registration number)" and announces it to the applicant, and the timing of this variety is automatically suspended
.
After all the species have been supplemented with the research materials, the task of related species will automatically resume timing
.
.
For example, when the company responds to the relevant content of the supplementary materials, it is mentioned that during the related review process, one of the varieties needs to supplement the research data, and the other related variety cannot be reviewed separately, the review timing of the related variety should be suspended simultaneously.
The reason for the suspension is "Pending the company's reply to issue additional information"
.
The chief reviewer fills in the "Response to the supplementary information for the related variety*** (related variety acceptance number or registration number)" and announces it to the applicant, and the timing of this variety is automatically suspended
.
After all the species have been supplemented with the research materials, the task of related species will automatically resume timing
.
The draft also defines related terms
.
During the review process, review timing management includes timing suspension and timing restoration
.
The suspension of review timing means that the review task of the drug registration application is suspended during the review process due to specific reasons, and the time used during the suspension is not included in the review time limit; the resumption of review timing means that the review task is suspended during the review time.
Later, when the specific reason for the suspension of the timing is eliminated, the timing shall be resumed
.
.
During the review process, review timing management includes timing suspension and timing restoration
.
The suspension of review timing means that the review task of the drug registration application is suspended during the review process due to specific reasons, and the time used during the suspension is not included in the review time limit; the resumption of review timing means that the review task is suspended during the review time.
Later, when the specific reason for the suspension of the timing is eliminated, the timing shall be resumed
.
On November 4, the Center for Drug Evaluation (CDE) of the State Food and Drug Administration (CDE) asked for comments on the "Management Regulations for the Suspension and Resumption of Review Timings in the Process of Drug Evaluation by the State Drug Administration (Trial) (Draft for Solicitation of Comments)" (hereinafter referred to as "Draft for Solicitation") Draft) Open for comments
.
The draft for comments proposes that one of the six cases of disapproval of publicity and dissent to the review conclusions will be suspended.
The time spent during the suspension shall not be included in the review time limit
.
The time limit for soliciting comments is two weeks from the date of publication of the draft for soliciting comments
.
.
The draft for comments proposes that one of the six cases of disapproval of publicity and dissent to the review conclusions will be suspended.
The time spent during the suspension shall not be included in the review time limit
.
The time limit for soliciting comments is two weeks from the date of publication of the draft for soliciting comments
.
According to the draft for comments, the six situations for the suspension of timing operations are: disapproval of publicity and dissent from the review conclusion; waiting for the company to reply and issue supplementary materials; waiting for an expert consultation meeting, etc.
; checking the production process, quality standards , and instructions And labeling; due to the applicant’s delay in verification, inspection, and rectification after verification, or initiation of overseas verification; circumstances in which the review process is suspended in accordance with laws, regulations , and rules
.
Among them, the circumstances in which the review procedure is suspended in accordance with laws, regulations, rules, etc.
, include situations in which the State Food and Drug Administration requires the suspension of the timing during the review process, situations in which the timing is suspended due to patent issues, situations in which the timing is suspended while waiting for supporting documents, and related Circumstances of suspension of timing of varieties and other circumstances
.
Enterprise Enterprise Enterprise Standards Standards Standards Regulations Regulations Regulations; checking the production process, quality standards , and instructions And labeling; due to the applicant’s delay in verification, inspection, and rectification after verification, or initiation of overseas verification; circumstances in which the review process is suspended in accordance with laws, regulations , and rules
.
Among them, the circumstances in which the review procedure is suspended in accordance with laws, regulations, rules, etc.
, include situations in which the State Food and Drug Administration requires the suspension of the timing during the review process, situations in which the timing is suspended due to patent issues, situations in which the timing is suspended while waiting for supporting documents, and related Circumstances of suspension of timing of varieties and other circumstances
.
The draft for comments detailed the specific operations of the suspension and resumption of timekeeping, classified in detail and made clear provisions on the suspension and resumption of timekeeping
.
For example, when the company responds to the relevant content of the supplementary materials, it is mentioned that during the related review process, one of the varieties needs to supplement the research data, and the other related variety cannot be reviewed separately, the review timing of the related variety should be suspended simultaneously.
The reason for the suspension is "Pending the company's reply to issue additional information"
.
The chief reviewer fills in the "Response to the supplementary information for the related variety*** (related variety acceptance number or registration number)" and announces it to the applicant, and the timing of this variety is automatically suspended
.
After all the species have been supplemented with the research materials, the task of related species will automatically resume timing
.
.
For example, when the company responds to the relevant content of the supplementary materials, it is mentioned that during the related review process, one of the varieties needs to supplement the research data, and the other related variety cannot be reviewed separately, the review timing of the related variety should be suspended simultaneously.
The reason for the suspension is "Pending the company's reply to issue additional information"
.
The chief reviewer fills in the "Response to the supplementary information for the related variety*** (related variety acceptance number or registration number)" and announces it to the applicant, and the timing of this variety is automatically suspended
.
After all the species have been supplemented with the research materials, the task of related species will automatically resume timing
.
The draft also defines related terms
.
During the review process, review timing management includes timing suspension and timing restoration
.
The suspension of review timing means that the review task of the drug registration application is suspended during the review process due to specific reasons, and the time used during the suspension is not included in the review time limit; the resumption of review timing means that the review task is suspended during the review time.
Later, when the specific reason for the suspension of the timing is eliminated, the timing shall be resumed
.
Medicine, medicine, medicine .
During the review process, review timing management includes timing suspension and timing restoration
.
The suspension of review timing means that the review task of the drug registration application is suspended during the review process due to specific reasons, and the time used during the suspension is not included in the review time limit; the resumption of review timing means that the review task is suspended during the review time.
Later, when the specific reason for the suspension of the timing is eliminated, the timing shall be resumed
.
