Does FDA accept PSUR?
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).
Is PSUR and Pbrer same?
Periodic Safety Update Reports (PSURs)/Periodic Benefit-risk Evaluation Reports (PBRER) Periodic safety update report (PSUR) provides a periodic and comprehensive assessment of the worldwide safety data of a marketed drug.
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.
Does FDA accept DSUR?
In contrast, a DSUR is a single document that was originally developed in Europe and is accepted by both the FDA and the European Medicines Agency (EMA).
When should a DSUR be submitted?
The DSUR should be submitted to all concerned regulatory agencies no later than 60 calendar days after the DSUR data lock point.
When should PSUR be submitted?
A PSUR should be submitted at least every six months after authorisation until the placing on the market. The PSUR covering this period during which the product is launched is considered the last of the six month PSURs to be submitted before ‘initial placing on the market’.
When should I submit PSUR?
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 included in PSUR?
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 the difference between a DSUR and annual report?
Generally, the contents of a DSUR and annual report are fairly similar (as outlined above). However, the DSUR tends to be a little more detailed in its data analysis and has a slightly stronger focus on potential impacts on patients.
How often is a PSUR submitted?
Is DSUR same as annual report?
What is PSUR why is it required?
What information should be included in PSUR?
Periodic safety update reports (PSUR)
- data from clinical and non-clinical studies;
- 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.
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 should a PSUR include?
What are the requirements for PSURs?
- 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 are PSUR submitted?
every 6 months until the product is placed on the market. every 6 months for the first 2 years after the product is placed on the market. once a year for the following 2 years.