What is a PSUR EMA?
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.
When should PSUR be submitted?
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 ad hoc PSUR?
“Ad hoc PSURs” means reports outside the routine reporting requirements, and may be requested by NDA.
What information should be included in the PSUR introduction?
The PSUR should focus on summary information, scientific safety assessment and integrated benefit-risk evaluation.
What is PSUR for medical devices?
The Periodic Safety Update Report (MDR PSUR) is an extension of a Post Market Surveillance Report (PMSR) that contains information for higher risk devices. The PSUR is intended for devices with moderate to high risk (IIa, IIb, III). It outlines the findings and conclusions derived from your PMS data.
What is PSUR why is it required?
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.
Who is responsible for PSUR?
Marketing authorisation holders (MAHs) are legally required to submit PSURs, in line with Regulation (EU) No 1235/2010, Directive 2010/84/EU and Commission Implementing Regulation (EU) No 520/2012. Article 35 of the Commission Implementing Regulation describes the structure of PSURs.
How do you write a PSUR for medical devices?
The PSUR should include:
- Conclusions of risk-benefit determination.
- Main findings of your Post Market Clinical Follow Up (PMCF)
- Sales volume of the device.
- Estimates of size of other characteristics of audience using the device (plus usage frequency if known)
Who is responsible for Psur?
What is the role of PSUR?
PSURs are intended to proactively present, analyze, and evaluate new or changing safety data from any source evaluated in relation to estimates of exposure to the product, although total coverage of data sources may have limitations in practice [2].
What is the difference between PMS and 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). It summarizes the results and conclusions from your PMS data.
What is PMS and PMCF?
Post-market surveillance (PMS) is complex and often misunderstood by device manufacturers. Europe’s new Medical Devices Regulation (MDR) adds to the complexity of complying with specific PMS and post-market clinical follow-up (PMCF) requirements.
What is the difference between PMSR and PSUR?
The PMSR is required for Class I medical devices and IVDs in Class A and B. Essentially, the PSMR is for low-risk devices and the PSUR is for those with a moderate or high risk. Your PMSR must be maintained and available to EU Competent Authorities upon request, but it does not need to be submitted on a regular basis.
What is the difference between PMS and Psur?
Is PMCF always required?
A PMCF plan as referred to in Part B of Annex XIV. PMCF is always applicable. A justification for not performing a PMCF study is required. Pane, et al present a template for compliance with MDR 2017/745.
Is PMCF required under MDD?
In this white paper, learn about PMCF studies in the context of the change from the current Medical Devices Directive 93/42/EU (MDD) to the new Medical Devices Regulation (MDR 2017/745/EU). All form fields are required.
What is a PSUR and what is it for?
A PSUR is a comprehensive, concise and critical analysis of the benefit-risk balance of a medicinal product in clinical practice, including its use in unauthorised indications as well as in line with the product information. PSUR reporting cycle is linked to the risk management system of a medicinal product. EURD list.
What is the EU PSUR single assessment (psusa)?
PSURs submitted in accordance with the EURD list are subject to the EU PSUR single assessment (PSUSA) procedure. EMA carries out PSUSA procedures to assess PSURs of medicines containing the same active substances or combinations, even if they are subject to different marketing authorisations and are authorised in different EU Member States.
When is a PSUR no longer required?
If the date is prior to the submission date specified in the EURD list, submission is no longer required except for exceptional cases for centrally authorised medicinal products, whereby the former marketing authorisation holder may be requested to submit a final / ad-hoc periodic safety update report (PSUR).
Do I need to submit psurs for medicinal products?
For medicinal product containing a known active substance, the requirement to submit a PSUR is only waived for those authorised under the legal basis mentioned above. Medicinal products containing a known substance authorised through another legal basis are required to submit PSURs.