The US is alone in requiring two different types of reports, referred to as the NDA (New Drug Application) safety update (“quarter- ly”) and the annual (“periodic”) reports, both covering clinical experience; however, the latter does not focus on detailed safety data. This guidance is intended to assist applicants and other responsible parties in fulfilling the FDA=s existing postmarketing safety reporting requirements for human marketed drug and biological. Periodic safety update report (PSUR) provides a periodic and comprehensive assessment of the worldwide safety data of a marketed drug. Over time it was recognized that the risk of the marketed drug should be assessed in the light of its benefits and change in the risk estimate overtime.
- Fda Periodic Safety Update Reports Definition
- Fda Periodic Safety Update Reports
- Fda Periodic Safety Update Reports Psurs
Periodic Adverse Drug Experience Report PADER
Post-approval cumulative reports of safety include Periodic Adverse Drug Experience Reports (PADERs) in the U.S. and Periodic Safety Update
Reports (PSUR) in many other regions, including in Europe. Their purpose is to update and evaluate the worldwide safety experience with a medicine
at defined time points after approval. Generally speaking, the Periodic Adverse Drug Experience Report PADER provide succinct summary information together with an evaluation of the benefit-risk profile of approved medicines in the light of new or changing post-approval information. This evaluation is designed to help ascertain whether further investigations are necessary and whether changes should be made to the approval or to the medicine’s labeling. In summary, the aim of cumulative reports of safety is to:
Reports (PSUR) in many other regions, including in Europe. Their purpose is to update and evaluate the worldwide safety experience with a medicine
at defined time points after approval. Generally speaking, the Periodic Adverse Drug Experience Report PADER provide succinct summary information together with an evaluation of the benefit-risk profile of approved medicines in the light of new or changing post-approval information. This evaluation is designed to help ascertain whether further investigations are necessary and whether changes should be made to the approval or to the medicine’s labeling. In summary, the aim of cumulative reports of safety is to:
- Report all the relevant new information from appropriate sources
- Relate these data to patient exposure to the medicine
- Summarize the medicine’s approval status in different countries and any significant variations related to safety
- Create periodically the opportunity for an overall reevaluation of safety
- Indicate whether changes should be made to an approved medicine’s label in order to optimize the use of the product
FDA has started accepting PADER/PAER Submission in eCTD Format from June 10, 2015.
Electronic Format of the Periodic Adverse Drug Experience Report PADER
FDA requires Industries to submit Periodic Adverse Drug Experience Report PADER in electronic format
The descriptive information portion of the PADER should be submitted as a PDF file to section 5.3.6 of the Electronic Common Technical Document (eCTD)
PADER is a single pdf file with proper bookmarks, Table of Contents and hyperlinking Submission in Electronic Format for Post Marketing Safety Reports, applies to all post marketing safety report for human drug and biologic products, includes individual case safety reports(ICSRs) and periodic safety reports.
The descriptive information portion of the PADER should be submitted as a PDF file to section 5.3.6 of the Electronic Common Technical Document (eCTD)
PADER is a single pdf file with proper bookmarks, Table of Contents and hyperlinking Submission in Electronic Format for Post Marketing Safety Reports, applies to all post marketing safety report for human drug and biologic products, includes individual case safety reports(ICSRs) and periodic safety reports.
PSUR Repository
Planning and preparation of the PSUR
![Safety Safety](/uploads/1/1/8/2/118236294/138996141.jpeg)
The use of the PSUR Repository has become mandatory in the European Union on 13 June 2016. The PSUR repository is a single, central platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the EU.
EMA´s Introductory cover note to the PSUR submission defines the procedure and how PSURs should be prepared and submitted for medicinal products in Europe.
Information important for the submission of the PSUR
For more details on the submission process please refer to the page Periodic safety update reports: questions and answers in the EMA Website.
List of Union reference dates and frequency of submission of periodic safety update reports (PSURs)
The PSUR list is updated on a monthly basis and any changes in the EURD list, such as the PSUR submission frequencies, the dates of submission and the PSUR submission requirement for medicinal products referred to in Articles 10(1), 10a, 14 or 16a of Directive 2001/83/EC come into force 6 months after its publication.
![Fda Periodic Safety Update Reports Fda Periodic Safety Update Reports](https://www.researchgate.net/profile/Hong_Fang/publication/259846609/figure/fig2/AS:282055968608278@1444258791485/Flowchart-of-study-on-US-Food-and-Drug-Administration-FDA-Adverse-Event-Reporting_Q320.jpg)
What is PSUR/PBRER?
A Periodic Safety Update Report or Periodic Benefit-risk Evaluation Reports are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation.
The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product, taking into account new or emerging safety information in the context of cumulative information on risk and benefits.
What is PADER?
Fda Periodic Safety Update Reports Definition
Periodic Adverse Drug Experience Report (PADER/PAER) is a part of post-cumulative safety reports which need to be submitted to the United States Food and Drug Administration (USFDA).
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.
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.
Fda Periodic Safety Update Reports
In summary, the aim of cumulative reports of safety is to:
- Report all the relevant new information from appropriate sources:
- Spontaneous notifications from health care professionals
- Spontaneous notifications from non-health care professionals or from consumers (non-medically substantiated)
- MAH-sponsored clinical studies or named-patient (“compassionate”) use
- Literature
- ADR reporting systems of regulatory authorities
- Other sources of data:
- – reports on ADRs exchanged between contractual partners (e.g., licensors- licensees)
- – data in special registries, such as maintained in organ toxicity monitoring centres
- – reports created by poison control centres
- – epidemiologic data bases
- Relate these data to patient exposure to the medicine
- Summarize the medicine’s approval status in different countries and any significant variations related to safety
- Create periodically the opportunity for an overall reevaluation of safety
- Indicate whether changes should be made to an approved medicine’s label in order to optimize the use of the product
Fda Periodic Safety Update Reports Psurs
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