The Periodic Safety Update Report must be submitted to the Notified Body or the Competent Authority (upon request) during the conformity assessment and it is a compulsory part of the technical documentation as per article 86 of EU MDR 2017/745. Fable the lost chapters mac. It must also be updated as and when required.
Overview. Periodic safety update reports (PSURs) are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorization holders (MAHs) at defined time points during the post-authorization phase. This refers to ICSRs (individual case safety reports) that involve a serious and unlisted event (an event not described in the drug's labeling) that is considered related to the use of the drug (US FDA).
A PADER is a type of aggregate safety report required to be submitted by a sponsor or marketing authorization holder (MAH) to the US Food and Drug Administration (FDA) after obtaining marketing authorization approval as per 314.80 (C) (2) and 600.80 (C)(2) guidelines.
PADERs are largely superceded by the new PBRER for hormonised use across all ICH regions. As per 21 Code of Federal Regulations (CFR) 314.80 US FDA recommends periodic submission of a PADER, MAH can submit PSUR/PBRER along with NDA listings (also called US Supplement/FDA PSUR) in place of PADER after obtaining a waiver per 314.90 (b) and 600.90 (b).
The main purpose of a PADER is to update and evaluate a medicine's global data and provide information about drug safety. It provides a brief summary of changing post-approval information of a drug along with the benefit-risk profile evaluation.
This evaluation provides insights, whether further changes are required for a medicine's labeling or if additional investigations are required.
Periodic Safety Update Report Psur
The main purpose of a PADER is to update and evaluate a medicine's global data and provide information about drug safety. It provides a brief summary of changing post-approval information of a drug along with the benefit-risk profile evaluation.
This evaluation provides insights, whether further changes are required for a medicine's labeling or if additional investigations are required.
Periodic Safety Update Report Psur
Submission of a PADER starts following completion of Phase 3 trials and with approval of a new drug application ([NDA] for innovator products), abbreviated NDA ([ANDA] for generic products), and biologic license application ([BLA] for biological products) by the US FDA.
Table of Contents for a PADER:
- A narrative summary and analysis of the information in the report and an analysis of the 15-day alert reports submitted during the reporting interval (all 15-day alert reports must appropriately reference the applicant's patient identification number, adverse reaction term(s), and date of submission to the FDA).
- A MedWatch form (3500A) for each adverse drug experience not reported as a 15-day expedited report (with an index consisting of a line listing of the applicant's patient identification number and adverse reaction term(s)).
- A history of actions taken since the last report because of adverse drug experiences (e.g., labeling changes or studies initiated).
- 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 they were conducted under an investigational New Drug Application), from reports in the scientific literature, or from foreign marketing experience.
- Follow-up information to adverse drug experiences submitted in a periodic report may be submitted in the next periodic report.
Fda Periodic Safety Update Report
As regulated by the FDA, organizations need to submit these reports once in a quarter for three years within 30 days of close of quarter and later should submit these reports annually within 60 days of US approval date. The PADER / PAER submissions are solely to be made in completely electronic format, i.e. in electronic Common Technical Document (eCTD).
