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What is regulatory timeline?
Regulatory timelines: The timeline for submitting an ICSR depends on country-specific regulatory requirements. The regulatory timeline starts from the Initial receipt date- “Day 0” of the ICSR. Calendar days are considered for calculating the due date for regulatory submission irrespective of weekends and holidays.
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 regulatory timeline for vaccine Susar?
A SUSAR that meets the seriousness criteria of life-threatening and/or results in death must be reported within seven (7) calendar days. A SUSAR that is not life-threatening or does not result in death must be submitted to the regulatory authorities within fifteen (15) calendar days.
What are solicited reports?
Solicited reports are those derived from organized data collection systems, which include clinical trials, registries, post-approval named patient use programs, other patient support and disease management programs, surveys of patients or healthcare providers, or information gathering on efficacy or patient compliance.
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.
What is the timeline for reporting any adverse event related case to PV department?
According to the General Reporting Requirements of the Individual Case Safety Reports (European Medicines Agency), all serious ADRs should be notified within 15 days and all non-serious ADRs should be notified within 90 days.
What is solicited reporting in pharmacovigilance?
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.
How long does it take to submit a PSUR?
within 90 calendar days of the data lock point (day 0) for PSURs covering intervals in excess of 12 months; the timeline for the submission of ad hoc PSURs requested by competent authorities will be normally specified in the request, otherwise the ad hoc PSURs should be submitted within 90 days of the data lock point.
What is a periodic safety update report (PSUR)?
What is a Periodic Safety Update Report (PSUR)? Periodic safety update reports are pharmacovigilance documents intended to provide a safety update resulting in an evaluation of the impact of the reports on the risk-benefit balance of a medicinal product.
What is the deadline for submitting ad hoc psurs?
the timeline for the submission of ad hoc PSURs requested by competent authorities will be normally specified in the request, otherwise the ad hoc PSURs should be submitted within 90 days of the data lock point. The deadline for the submission of PSURs (Day 70 or Day 90 following the DLP) is published in the EURD list.
What is the ICSR reporting timeline for a case?
Once ICSR assessed for seriousness, causality and labelling, case will be submitted to regulatory authority. ICSR reporting timelines primarily vary based on the seriousness of an event and the nature of the reporter. Also, timelines in pharmacovigilancemake use of a concept called calendar days rather than weekdays or weekends.