PBRERs
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Submitting PBRER instead of PADER
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Change in the Date of the DLP for the PBRER
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PADERs and Aggregate Reports in US
VigiServe Admin@admin
#1 · December 5, 2020, 9:53 AM
Quote from VigiServe Admin on December 5, 2020, 9:53 AMTiming of Postmarketing Periodic Reports"Postmarketing periodic reports are required to be submitted to the FDA for each approved NDA, ANDA, and BLA and are due quarterly for the first 3 years after U.S. approval of the application and annually thereafter. If marketing is delayed, these reports should still be submitted quarterly for the first 3 years of marketing. Upon written notice, the FDA may extend or reestablish the requirement that an applicant submits quarterly reports or require that the applicant submit periodic reports at different time intervals.”
Periodic adverse drug experience reports.
(i) The applicant must report domestic, non-15 day reports at quarterly intervals, for 3 years from the date of approval of the application, and then at annual intervals. The applicant must submit each quarterly report within 30 days of the close of the quarter (the first quarter beginning on the date of approval of the application) and each annual report within 60 days of the anniversary date of approval of the application. Upon written notice, FDA may extend or reestablish the requirement that an applicant submits quarterly reports, or require that the applicant submit reports under this section at different times than those stated. For example, the agency may reestablish a quarterly reporting requirement following the approval of a major supplement. Followup information to adverse drug experiences submitted in a periodic report may be submitted in the next periodic report.
(ii) Each periodic report is required to contain:
(A) Descriptive information.
(1 ) A narrative summary and analysis of the information in the report;
(2 ) An analysis of the 15-day Alert reports submitted during the reporting interval (all 15-day Alert reports being appropriately referenced by the applicant's patient identification code, adverse reaction term(s), and date of submission to FDA);
(3 ) A history of actions taken since the last report because of adverse drug experiences (for example, labeling changes or studies initiated); and
(4 ) An index consisting of a line listing of the applicant's patient identification code, and adverse reaction term(s) for all ICSRs submitted under paragraph (c)(2)(ii)(B) of this section.
(B) All domestic serious, expected and nonserious adverse drug experiences. All such ICSRs must be submitted to FDA (either individually or in one or more batches) within the specified timeframe. ICSRs must only be submitted to FDA once.
(iii) Periodic reporting, except for information regarding 15-day Alert reports, does not apply to adverse drug experience information obtained from postmarketing studies (whether or not conducted under an investigational new drug application), from reports in the scientific literature, and from foreign marketing experience.
Timing of Postmarketing Periodic Reports
"Postmarketing periodic reports are required to be submitted to the FDA for each approved NDA, ANDA, and BLA and are due quarterly for the first 3 years after U.S. approval of the application and annually thereafter. If marketing is delayed, these reports should still be submitted quarterly for the first 3 years of marketing. Upon written notice, the FDA may extend or reestablish the requirement that an applicant submits quarterly reports or require that the applicant submit periodic reports at different time intervals.”
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#2 · December 5, 2020, 10:00 AM
Quote from VigiServe Admin on December 5, 2020, 10:00 AMFDA Waivers - Aggregate ReportsFDA does provide a waiver to the Marketing Authorization Holders (ANDA/NDA Holders), in case they wish to submit PSURs in the ICH E2C-R2 format instead of the PADER format.
If the applicant’s PSUR waiver specifies annual PSUR submission but the applicant wishes to submit a PBRER every 3 years, the applicant can substitute the PBRER for the PSUR, provided the applicant submits a PADER/PAER for years 1 and 2 of the 3-year PBRER cycle to maintain the annual reporting frequency required under the regulations and as specified in its PSUR waiver.
Change in the Date of the DLP for the PBRER
Submit Notification If applicants wish to use a DLP date for the PBRER that is different than the DLP date used for the PSUR, applicants should ensure there are no gaps in reporting intervals resulting from the change in DLP.
Examples of appropriate alternatives include the following:
• Submit overlapping reports to cover the gap.
• Submit a one-time PADER/PAER to cover the gap.
• Extend the reporting interval of the applicant’s upcoming PADER/PAER by up to 3 months to cover the gap.
What should be included in a Waiver request?
The product name(s) and application number(s).
A brief description of the justification for the request.
The U.S. approval date for the product(s) and current reporting interval used.
The reporting interval of the last PADER/PAER submitted for the product(s).
The data lock point you intend to use for each PBRER. If you propose a data lock point other than one aligned to the U.S. approval date, you should describe how you will ensure there are no gaps in reporting intervals.
The frequency with which you intend to submit reports.
The PBRER may be used with US specific appendices
Submission may be in the 70/90 day timelines in the ICH guideline
FDA Waivers - Aggregate Reports
FDA does provide a waiver to the Marketing Authorization Holders (ANDA/NDA Holders), in case they wish to submit PSURs in the ICH E2C-R2 format instead of the PADER format.
PBRERs
-
Submitting PBRER instead of PADER
-
Change in the Date of the DLP for the PBRER
If the applicant’s PSUR waiver specifies annual PSUR submission but the applicant wishes to submit a PBRER every 3 years, the applicant can substitute the PBRER for the PSUR, provided the applicant submits a PADER/PAER for years 1 and 2 of the 3-year PBRER cycle to maintain the annual reporting frequency required under the regulations and as specified in its PSUR waiver.
Change in the Date of the DLP for the PBRER
Submit Notification If applicants wish to use a DLP date for the PBRER that is different than the DLP date used for the PSUR, applicants should ensure there are no gaps in reporting intervals resulting from the change in DLP.
Examples of appropriate alternatives include the following:
• Submit overlapping reports to cover the gap.
• Submit a one-time PADER/PAER to cover the gap.
• Extend the reporting interval of the applicant’s upcoming PADER/PAER by up to 3 months to cover the gap.
What should be included in a Waiver request?
-
The product name(s) and application number(s).
-
A brief description of the justification for the request.
-
The U.S. approval date for the product(s) and current reporting interval used.
-
The reporting interval of the last PADER/PAER submitted for the product(s).
-
The data lock point you intend to use for each PBRER. If you propose a data lock point other than one aligned to the U.S. approval date, you should describe how you will ensure there are no gaps in reporting intervals.
-
The frequency with which you intend to submit reports.
-
The PBRER may be used with US specific appendices
-
Submission may be in the 70/90 day timelines in the ICH guideline
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Last edited on December 5, 2020, 10:49 AM by VigiServe Admin
Periodic adverse drug experience reports.
(i) The applicant must report domestic, non-15 day reports at quarterly intervals, for 3 years from the date of approval of the application, and then at annual intervals. The applicant must submit each quarterly report within 30 days of the close of the quarter (the first quarter beginning on the date of approval of the application) and each annual report within 60 days of the anniversary date of approval of the application. Upon written notice, FDA may extend or reestablish the requirement that an applicant submits quarterly reports, or require that the applicant submit reports under this section at different times than those stated. For example, the agency may reestablish a quarterly reporting requirement following the approval of a major supplement. Followup information to adverse drug experiences submitted in a periodic report may be submitted in the next periodic report.
(ii) Each periodic report is required to contain:
(A) Descriptive information.
(1 ) A narrative summary and analysis of the information in the report;
(2 ) An analysis of the 15-day Alert reports submitted during the reporting interval (all 15-day Alert reports being appropriately referenced by the applicant's patient identification code, adverse reaction term(s), and date of submission to FDA);
(3 ) A history of actions taken since the last report because of adverse drug experiences (for example, labeling changes or studies initiated); and
(4 ) An index consisting of a line listing of the applicant's patient identification code, and adverse reaction term(s) for all ICSRs submitted under paragraph (c)(2)(ii)(B) of this section.
(B) All domestic serious, expected and nonserious adverse drug experiences. All such ICSRs must be submitted to FDA (either individually or in one or more batches) within the specified timeframe. ICSRs must only be submitted to FDA once.
(iii) Periodic reporting, except for information regarding 15-day Alert reports, does not apply to adverse drug experience information obtained from postmarketing studies (whether or not conducted under an investigational new drug application), from reports in the scientific literature, and from foreign marketing experience.