What is included in PSUR?
spontaneous reports (e.g. on the marketing authorisation holder’s safety database); product usage data and drug utilisation information; observational studies, including registries; scientific literature.
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 information should be included in the periodic safety update report introduction?
Periodic Safety Update Reports (PSURs)
- Introduction.
- Worldwide marketing Authorization.
- Update of Regulatory authorities or MAH actions taken for safety reasons.
- Changes in reference safety information.
- Patient Exposure.
- Presentation of Individual case Histories.
- Table of Contents of the PSUR. Studies. Other Information.
What is the difference between PSUR and DSUR?
The DSUR is the pre-marketing equivalent of the post-marketing Periodic Safety Update Report (PSUR). It covers drugs, biological, vaccines and combo products.
What is PSUR PPT?
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 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.
How do I submit to PSUR?
PSUR submissions to the Repository are made using the eSubmission Gateway/Web Client with the use of an XML delivery file. The delivery files are used to provide required metadata allowing the EMA to process the submissions.
What is the purpose of PSUR?
PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation.
What is SUSAR reporting?
SUSAR. An SAE that occurs during research with a medicinal product may be a SAR or a SUSAR. SAR is the abbreviation for Serious Adverse Reaction, and SUSAR for Suspected Unexpected Serious Adverse Reaction. SUSARs have to be reported to the reviewing MREC from the moment the dossier is submitted.
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.
Who is responsible for the PSUR?
The Marketing Authorization Holder is responsible for the submission of the PSURs for his products [Article 107b DIR] [Article 28 (2) of the REG].
