CDE issued the "Management Regulations for the Suspension and Resumption of Review Timings in the Drug Review Process of the State Drug Administration" (Draft)!

(Draft for comments)

Chapter One General Provisions

Article 1 (Basis) is to standardize the time management of drug review and ensure that the review process is legal and compliant, fair and just, open and transparent, in accordance with the "Pharmaceutical Administration Law of the People's Republic of China", the "Vaccine Management Law of the People's Republic of China", and the "People's Republic of China" Laws, regulations and rules such as the Patent Law of the Republic and the Measures for the Administration of Drug Registration (hereinafter referred to as the “Measures”) formulate these norms

Article 2 (Time Limit Review) The Drug Evaluation Center of the State Drug Administration (hereinafter referred to as "Drug Review Center") reviews drug registration applications within a time limit to ensure that the time limit for drug registration is predictable, but there are still some non-technical reviews For special circumstances caused by reasons, the review timing shall be suspended, and the review timing shall be resumed after the reasons for the suspension are eliminated

Article 3 (Definition) During the review process, review timing management includes timing suspension and timing restoration

Article 4 (Suspension Circumstances) According to the relevant provisions of the "Measures", combined with the actual work situation of drug review, if one of the following situations exists, the timing operation shall be suspended :

(1) Refusal to approve the publicity and dissent from the review conclusion;

(2) Waiting for the enterprise to reply and issue supplementary materials;

(3) Waiting for an expert consultation meeting, etc.

(4) Checking the production process, quality standards, instructions and labels;

(5) Delayed verification, inspection, rectification after verification due to the applicant's reasons, or initiation of overseas verification:

1. Circumstances where the verification is delayed due to the applicant;

2. Circumstances where inspection is delayed due to the applicant;

3. Circumstances where the rectification is delayed due to the applicant’s inspection;

4. Circumstances for initiating overseas verification

(6) Circumstances in which the review procedure is suspended in accordance with laws, regulations, rules, etc .

1. Circumstances in which the State Drug Administration requested the suspension of timekeeping during the review process;

2. Circumstances involving suspension of timekeeping on patent issues;

3. Circumstances where the timing is suspended while waiting for supporting documents;

4. Circumstances of suspension of timing for related varieties;

5. Other situations

Article 5 (Publicity and Inquiry) The Center for Drug Evaluation will disclose the review timing of the variety under review to the applicant through the "Applicant's Window", and the registration applicant can view the specific reasons for the suspension of the timing through the "Applicant's Window"

Article 6 (Scope of Application) This specification is applicable to the review tasks of registration applications for all types of drugs (including APIs) and related review tasks of pharmaceutical excipients and packaging materials, including drug marketing authorization applications, drug supplement applications, and reprocessing of imported drugs.
registration, evaluation application consistency and so on
.

If there are special regulations in the consistency evaluation application, it shall be implemented in accordance with the relevant regulations
.

Drug clinical trial applications are only applicable to the first case in these Measures, that is, the case of disapproval of publicity and dissent from the review conclusion
.

Chapter 2 Specific Operations for Suspension and Resumption of Timekeeping

Article 7 (Details of disapproval of publicity) Circumstances of " disapproval of publicity and handling of objections to review conclusions ":

If the review conclusion is not passed , the Center for Drug Evaluation shall notify the applicant through the "Applicant Window" 15 days before the expiration of the review time limit, and the time will be automatically suspended
.
The applicant can file an objection through the "Applicant's Window" within 15 days from the date of receipt of the notification letter, and the review time will be resumed automatically after 15 days
.
If the applicant raises an objection, refer to the relevant provisions of the "Drug Registration Evaluation Conclusion Objection Resolution Procedure (Trial)" and return to the review department for reassessment; if the applicant does not raise an objection, it will automatically be transferred to the next post
.

Article 8 (Details of the supplementary materials to be replied by the enterprise ) The situation of " waiting for the reply and issuance of supplementary materials by the enterprise ":

If the applicant needs to supplement and improve the research materials during the review process, if the supplementary information notice is sent in writing, the time will be automatically suspended from the date of mailing; if the supplementary information notice is sent by electronic push, from the date of issue , The timing is automatically stopped
.
After the applicant submits all the supplementary research data, the Center for Drug Evaluation will confirm whether it meets the requirements of the "Regulations for the Acceptance and Review of Supplementary Materials for Drug Evaluation Center" (trial implementation) within 5 days
.

In the process of related review, if one of the varieties needs to submit additional research data, and the other related variety cannot be reviewed separately , the review timing of the related varieties should be suspended simultaneously.
The reason for the suspension is "waiting for the company to reply and issue additional data"
.
The chief reviewer fills in the "Response to supplementary information for the related variety*** (relevant 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
.

If the preparation and the associated original and auxiliary package are issued with a supplementary information notice , the lead reviewer of the preparation fills in the relevant acceptance number and publicizes it to the applicant, and the preparation and the associated original and auxiliary package automatically stop timing
.
After all the varieties have responded to the supplementary information, the review system will automatically resume the timing
.

Article 9 (Details of convening an expert consultation meeting) Circumstances of "convening an expert consultation meeting":

If it is deemed necessary to convene an expert consultation meeting after the review, in accordance with the relevant specifications and requirements of the expert consultation meeting, the reviewer puts forward the demand for convening an expert consultation meeting in the review system, and the time is automatically suspended after the review and approval
.
The Center for Drug Evaluation shall organize an expert consultation meeting within 30 days (except for applicants applying for extension of the meeting)
.
The timing will automatically resume on the second day after the expert consultation is completed
.

Article 10 (Checking the production process, quality standards, instructions and label details) is a situation of " checking the production process, quality standards, instructions and labels ":

During the professional review process, the work of checking the production process, quality standards, instructions or packaging labels with the applicant shall be carried out at the same time
.
Each professional reviewer uploads the documents that need to be verified in the "Production Process, Quality Standards, Manual Verification" module in the "Applicant's Window", and submits verification requirements to the applicant
.
After all the documents to be checked are uploaded, the chief reviewer submits an application for suspension of the review timing, and the review timing shall be suspended after review
.
Applicants should verify all documents and upload them to the "Applicant's Window" on the 7th
.
Each professional chief reviewer shall review the documents within 15 days after the registration applicant uploads all the documents, and the review system will automatically resume the timing on the 16th day (if the review is completed within 15 days, the review timing may also be initiated by the chief reviewer )
.
During the professional review process, the timing is only suspended once
.

During the comprehensive review process, if the applicant needs to reconfirm the production process, quality standards, instructions or packaging labels , the chief reviewer will upload the professional report in the "Production Process, Quality Standards, Manual Verification" module in the "Applicant's Window".
The above-mentioned documents that have been approved during the review process, and an application for suspension of review timing shall be submitted, and the review timing shall be suspended after review
.
Applicants should verify all documents and upload them to the review system on the 7th
.
The chief reviewer (if necessary, a professional chief reviewer) shall review the documents within 5 days after the registration applicant uploads all the documents
.
The review system automatically resumes the timing on the 6th day (if the review is completed in advance within 5 days, the review timing can also be started by the main reviewer)
.
The timing of the comprehensive review was only suspended once
.

If the applicant fails to upload the documents to be checked within 7 days, the applicant shall inform the Center for Drug Appraisal of the specific reasons for not being able to submit.
At the same time, the follow-up technical review of the same variety will be completed within the time limit, and no longer wait for the variety
.
If the quality of the verification documents submitted many times by the applicant is too poor, a written supplementary notice may be issued when necessary
.

Article 11 (Waiting for verification or detailed inspection report) is a situation of " delaying verification, inspection, rectification after verification due to the applicant's reasons, or initiating overseas verification" :

When the technical review is completed, if the inspection or inspection is delayed due to the applicant's reasons, the rectification after the inspection, or the overseas inspection is initiated, and the inspection report is not received 40 days before the expiration of the review time limit, the timing shall be suspended
.
If the review conclusion is that the applicant needs to supplement the research materials, this suspension situation does not apply
.
The specific types are as follows:

(1)   Circumstances of delayed verification due to the applicant

After the notification of drug verification is issued, the applicant shall submit a verification application to the verification center within the prescribed time limit.
If the verification needs to be delayed due to the applicant's reasons, the applicant shall submit an extension application to the verification center
.
If the inspection report is not received forty days before the expiration of the review time limit, after confirmation by the Center for Drug Evaluation, the chief reviewer can choose to suspend the timing of the inspection due to the applicant’s delay and check the type of inspection
.
After the drug review center receives all the verification reports, if it is confirmed within 5 days, the review system will automatically resume timing on the 6th day
.

(2)   Circumstances where inspection is delayed due to the applicant

After the notification of drug inspection is issued, the applicant shall submit an inspection application to the drug inspection agency within the prescribed time limit.
If the inspection needs to be delayed due to the applicant's reasons, the applicant shall submit an extension application to the drug inspection agency
.
If the inspection report is not received forty days before the expiration of the review time limit, after confirmation by the Center for Drug Evaluation, the chief reviewer can choose to stop the timing of the "inspection delay due to the applicant's reasons"
.
After the drug review center receives the inspection report, if it is confirmed within 5 days, the review system will automatically resume timing on the 6th day
.

If verification and inspection are involved at the same time, and the delay is due to the applicant, choose the first and second cases to suspend the timing
.
After the drug review center receives the verification report and inspection report, if it is confirmed within 5 days, the review system will automatically resume timing on the 6th day
.

(3)   Circumstances where rectification is delayed due to the applicant’s inspection

After the verification is completed, if the applicant needs to make rectification, and the applicant delays in submitting the rectification report, the applicant shall submit an extension application to the verification center
.
If the verification report is not received forty days before the expiration of the review time limit, after confirmation by the Center for Drug Evaluation, the chief reviewer can choose to suspend the timing on the initiative of “the rectification delay after verification due to the applicant’s reasons”
.
After the drug review center arrives at the verification report, if the verification report is confirmed within 5 days, the review system will automatically resume timing on the 6th day
.

(4) Circumstances of initiating overseas verification

For the initiation of overseas inspections, if the inspection report is not received 40 days before the expiration of the review time limit, upon confirmation by the Center for Drug Appraisal, the lead reviewer may choose to suspend the timekeeping initiatively under the “circumstances of initiating overseas inspections”
.
After the drug review center receives the verification report, if it is confirmed within 5 days, the review system will automatically resume timing on the 6th day
.

Initiation of verification and inspection of related-assessed varieties shall be handled in accordance with the above circumstances
.
In the process of related review, if one of the varieties is waiting for verification or inspection, and other varieties cannot be reviewed separately, the main reviewer will also voluntarily stop the timing according to the suspension of the related variety, and fill in the "species to be related***" (Related Variety Acceptance Number) Verification/Inspection Report" and publicize it to the applicant
.
When the applicant submits the report and confirms that it is correct, the related varieties will automatically resume the timing
.

Article 12 (Detailed details of the suspension of review and approval procedures in accordance with laws, regulations, rules, etc.
) fall under the circumstances of " suspension of review procedures in accordance with laws, regulations, and rules, etc.
":

If the review is suspended in accordance with laws, regulations, rules, etc.
, the review procedure shall be suspended in accordance with the provisions of laws, regulations, rules, etc.
, and the specific basis shall be selected or filled in truthfully, and the timing shall be resumed proactively when the reason for the suspension is eliminated
.
The specific situation is as follows:

(1) During the review process, the State Drug Administration (hereinafter referred to as the "National Bureau") requests the suspension of timekeeping:

After completing the technical review, the main reviewer selected "Suspension of review procedures in accordance with laws, regulations, rules, etc.
" in the "State Administration's request to suspend review" to voluntarily suspend the timing
.
After the National Bureau agrees to resume the review, the chief reviewer will resume the review time on his own initiative
.

(2) Circumstances of suspension of timing involving patent issues:

If a patent issue is involved, it shall be implemented in accordance with the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)"
.

1. For the chemical generic drugs declared in the fourth category of Article 6 of the Measures, after completing the technical review within the waiting period, if the effective judgment of the people’s court or the administrative ruling of the Patent Administration Department of the State Council is not received, the review system automatically suspends the timing for the reason In "Suspension of review procedures in accordance with laws, regulations, and rules, etc.
   ", "Involving varieties with waiting period", the review system will automatically resume timing 20 days before the waiting period is eliminated
   .
   

2. If the effective judgment of the people’s court or the administrative ruling of the patent administration department of the State Council confirms that it falls within the scope of relevant patent protection, the suspension of time will be automatically executed after the completion of the technical review.
   The reason is that "the review procedure is suspended in accordance with laws, regulations, rules, etc.
   " The technical review has been completed because the patent has not expired and the submission to the Office for approval has been suspended"
   .
   20 days before the expiration of the patent, the review system will automatically resume timing
   .
   

3. For chemical generic drugs that have been granted a period of market exclusivity, after the technical review of other products of the same type is completed, if the period of market exclusivity is still completed, the review system will automatically suspend the timing.
   "Involving market-exclusive varieties" in the evaluation procedure
   .
   20 days before the expiration of the market exclusivity period, the review system will automatically resume timing
   .
   

(3) Circumstances where the timing is suspended while waiting for supporting documents:

For the products that are applying for marketing, the applicant will be notified to submit the latest supporting documents during the review process.
If the applicant has not submitted the relevant supporting documents at the end of the review, the Center for Drug Evaluation will select “in accordance with laws, regulations, and rules, etc.
” The "waiting for supporting documents" in the "Suspension of Review Procedures" automatically suspends the timing, and tick the types of supporting documents that need to be submitted
.
After the applicant submits all supporting documents for confirmation, the timing will be resumed automatically
.

(4)   Circumstances of suspension of timing for related varieties

In the process of related review, if the related varieties cannot complete the technical review normally due to reasons, and do not meet the relevant circumstances of Article 8 and Article 11 above, the chief reviewer shall suspend in accordance with “in accordance with laws, regulations, rules, etc.
The "Circumstances of suspension of timing of related varieties" in the "review procedure" voluntarily suspend timing, and publicize specific related variety information to the applicant
.
After the cause of the related variety is eliminated, the chief reviewer will resume the timing on his own initiative
.

(5) Other circumstances

For other uncovered matters that meet the requirements after being approved by the National Bureau or the Drug Evaluation Center, the professional lead reviewer or the lead reviewer can choose to “suspend the review procedure in accordance with laws, regulations, rules, etc.
” in “other circumstances” to voluntarily suspend Timing, and the reason for the suspension of timing shall be announced to the applicant
.
After the reason for the suspension of the timing is eliminated, the professional chief reviewer or the chief reviewer will resume the timing in a timely manner
.

Chapter III Supplementary Provisions

Article 13 (Communications) During the review process, if the applicant has any objections to the review timing, it can be raised through the "review timing" module of the "general technical issues"
.
For the objection raised by the applicant, the Center for Drug Evaluation shall explain to the applicant
.

Article 14 (Requirements for Time Limit) The time limit specified in this Management Code is calculated in working days
.

Article 15 (Implementation Date) This management specification shall be implemented from the date of issuance
.

Attachment: The content of the suspension time announced to the applicant

(1) Disapproval of the publicity and handling of objections to the review conclusions;

(2) Waiting for the enterprise to reply and issue supplementary materials;

Option: "To be related species*** (relevant species acceptance number) reply and issue supplementary information"

(3) Waiting for the convening of expert consultation meetings and other meetings;

(4) Check the production process, quality standards, instructions and labels;

Options: "Production Process", "Quality Standards", "Instructions" and "Packaging Labels", etc.
At the same time, inform the applicant that all documents to be checked must be submitted within 7 days
.

(5) Delayed verification, inspection, verification rectification or initiation of overseas verification due to the applicant’s reasons

1. Circumstances where the verification is delayed due to the applicant;

   Options: "production site inspection", "development verification", "clinical verification", other

2. Circumstances where inspection is delayed due to the applicant;

3. Circumstances where the rectification is delayed due to the applicant’s inspection;

4. Circumstances for initiating overseas verification

   Option: "Variety to be associated *** (Related Variety Acceptance Number) Verification or Inspection Report"

(6) Suspension of review procedures in accordance with laws, regulations, and rules

1. "The National Bureau requests to suspend the review"

2. Circumstances of suspension of timing involving patent issues

   Options: "Involving varieties with a waiting period"; "Sending the approval of the bureau for approval due to a pending patent due to the completion of technical review"; "Involving varieties with a market exclusive period"

3. Circumstances where the timing is suspended while waiting for supporting documents

   Options: production license, business license, GMP, certification documents that allow marketing, other

4. Circumstances of suspension of timing for related products

   Option: Associated Variety Acceptance Number

   Other situations

   Option: fill in the specific reason for stopping the timing