What is the meaning of PSUR?
Periodic Safety Update Report
A Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an update of the worldwide safety experience of a medicinal product to regulatory authorities at defined time points post-authorisation.
What is PMS and PSUR?
The MDR and IVDR require either a “Post-market surveillance report” or a “Periodic safety update report” from medical product manufacturers. The periodic safety update report is abbreviated as “PSUR”, the post-market surveillance reports as “PMS report”. A synonym of PSUR is “safety report”.
When should I submit PSUR?
Regardless of whether the EBD or the IBD is used, the PSUR should always be submitted within 60 days after the DLP. The MAH is obliged to inform the Agency of the date of initial placing of the product on the market of the European Union.
What is Volume 9a pharmacovigilance?
Volume 9 of “The rules governing medicinal products in the European Union” contains Pharmacovigilance guidelines for medicinal products for both human and veterinary use.
What is PSUR writing?
PSURs are important pharmacovigilance documents applying to drugs already approved for marketing – regularly updating regulatory authorities on the worldwide safety experience of approved drugs.
What is Psur Slideshare?
Definition • 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 authorisation holders at defined time points during the post- authorisation phase.
What is PMCF plan?
A PMCF Plan is an important technical document that outlines a method for conducting Post-Market Clinical Follow-up on a medical device. A PMCF Plan must be submitted for regulatory approval of devices under the MDR as a component of the MDR Annex II technical documentation.
How do I review PSUR?
First, just a quick comment on how the medical review of the PSUR should be done by the sponsor/Marketing Authorization Holder (MAH). First there should be a quality review to be sure that the mechanical and operational aspects are correct (pagination, references to tables, column totals etc.).
What is part lll of Volume 9A?
Volume 9A is presented in four parts: -Part I deals with Guidelines for Marketing Authorisation Holders; -Part II deals with Guidelines for Competent Authorities and the Agency; -Part III provides the Guidelines for the electronic exchange of pharmacovigilance in the EU; and -Part IV provides Guidelines on …
What’s the difference between a pMSR and a PSUR?
The Periodic Safety Update Report (PSUR) is essentially an extension of a Post Market Surveillance Report (PMSR) containing information for higher risk devices. The PSUR is intended for moderate and high-risk devices (Class IIa, IIb, III, implantables).
What does PSUR stand for in medical category?
The term PSUR comes from the previous ICH E2C (R1) “ Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs ”. ICH guideline E2C has been subsequently revised and renames as Periodic Benefit-Risk Evaluation Report (PBRER) (see below).
What does periodic safety update report ( PSUR ) mean?
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 authorisation holders at defined time points during the post-authorisation phase.
When did the use of the PSUR become mandatory?
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.