Description
This guidance describes the conditions under which applicants can use an alternative reporting format, the International Council for Harmonisation (ICH)3 E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER), in place of the U.S. periodic adverse drug experience report (PADER), U.S. periodic adverse experience report (PAER), or ICH E2C Periodic Safety Update Report (PSUR), to satisfy the periodic postmarketing safety reporting requirements in §§ 314.80(c)(2) and 600.80(c)(2) (21 CFR 314.80(c)(2) and 600.80(c)(2)). This guidance also describes the procedures applicants should follow if they wish to submit a PBRER in place of a PADER, PAER, or PSUR. The steps will differ, depending on whether or not the applicant has an approved waiver in place to substitute the PSUR for the PADER/PAER.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Stakeholders
1entity submitting marketing applications
Regulatory Context
Regulatory Activities
5Electronic Common Technical Document format for submissions; Electronic Common Technical Document specifications; Electronic Common Technical Document submission format; Electronic Common Technical Document specifications for submissions
Request to waive regulatory requirements under 314.99(b).
Biologics License Application
Abbreviated New Drug Application
New Drug Application
Document Types
5Individual Case Safety Report
Periodic Safety Update Report
U.S. periodic adverse experience report; Periodic Adverse Experience Report
U.S. periodic adverse drug experience report; Periodic Adverse Drug Experience Report
Periodic Benefit-Risk Evaluation Report; Periodic Benefit-Risk Evaluation Report used for safety reporting.; Periodic Benefit-Risk Evaluation Report used for benefit-risk assessment
Attributes
2The date designated as the cut-off for data to be included in the report
Data Lock Point for the PBRER
Technical Details
Substances
1Basis for determining drug sameness
Clinical Concepts
1description of an event related to an individual patient or subject
ICH References (2)
Source of the definition for Spontaneous Reporting
Periodic Benefit-Risk Evaluation Report (PBRER) standard for marketed products; Periodic Benefit-Risk Evaluation Report guidance; The primary guidance document for Periodic Benefit-Risk Evaluation Reports.; Periodic Benefit-Risk Evaluation Report (PBRER) guidance
Related CFR Sections (5)
- 21CFR600.80§ 600.80 Postmarketing reporting of adverse experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR600.90§ 600.90 Waivers.
(a) An applicant may ask the Food and Drug Administration to waive under this section any requirement that applies to the applicant under §§ 600.80 and 600.81 . A waiver request under this section is required to be submitted with supporting documentation. The waiver request is required to contain onRead full regulation →
- 21CFR314.90§ 314.90 Waivers.
(a) An applicant may ask the Food and Drug Administration to waive under this section any requirement that applies to the applicant under §§ 314.50 through 314.81 . An applicant may ask FDA to waive under § 314.126(c) any criteria of an adequate and well-controlled study described in § 314.126(b) . Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments (Status: Final)
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
- CPG Sec. 442.100 New Drugs - Export (Status: Final)
- CPG Sec. 400.325 Candy "Pills" Representation as Drug (Status: Final)
- CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines (Status: Final)
- CPG Sec. 446.100 Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations (Status: Final)
- CPG Sec. 450.300 OTC Drugs - General Provisions and Administrative Procedures for Marketing Combination Products (Status: Final)