What should a PSUR include?
According to MDR and IVDR, PSURs must include:
- Post-market surveillance data.
- A rationale and description of any corrective actions taken for product on the markets.
- A summary of post-market information.
- Vigilance reporting.
- The current status of the device on the market in the EU.
How often is a PSUR submitted?
PSURs must be submitted every 6 months after product authorisation until 2 years after the initial placing on the EU market, yearly for the following 2 years, and at 3-year intervals thereafter.
What is EURD list?
The European Union reference dates (EURD) list is a comprehensive list of active substances and combinations of active substances contained in medicinal products subject to different marketing authorisations, together with the corresponding EU reference dates, frequencies for submission of periodic safety update …
What is PSUR and RMP?
ยท Focus of PSUR is retrospective review of integrated risk benefit analysis whereas RMP is proactive prospective plan to deal with known risks and identify and further characterize little known risks.
How do you write a PSUR?
Top 10 Tips for Writing PSURs and PMS Reports
- Keep the goal top of mind.
- Align your report with your PMS plan.
- Identify and gather source data.
- Meet the minimum data requirements outlined in the regulation.
- Perform data analysis.
- Reference previous PSURs/PMS reports.
- Review literature on a regular basis.
What is EU 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 the difference between PSUR and DSUR?
The Development Safety Update Report (DSUR) is used for drugs still under development to assess risk to the subjects enrolled in the study, while the Periodic Safety Update Report (PSUR) is used for drugs already on the market to assess long-term safety.
What is PSUR clinical trial?
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 a PSUR FDA?
The PSURs (Periodic Safety Update Report) have been around for many years. They are standardized and accepted by most health authorities (including FDA, Health Canada, the EU). A PSUR covers one entity (all indications, dose forms, routes of administration and regimens).
What is a Type 2 variation?
A major change to a marketing authorisation that may have a significant impact on the quality, safety or efficacy of a medicine, but does not involve a change to the active substance, its strength or the route of administration.