What are regulatory timelines?

What are regulatory timelines?

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.

What are the timelines for pharmacovigilance?

Clinical Death/Life threatening cases and SUSAR (Suspected Unexpected Serious Adverse Reaction) cases are reported within 7 calendar days to the NCA (national competent authorities)/HA (health authorities). Clinical trial other Serious cases and safety issues are reported in 15 days calendar days timeframe.

What is the timeline for reporting any adverse event Releatd to case of 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.

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What is Susar and their reporting timelines?

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 is regulatory reporting in pharmacovigilance?

Regulatory reporting timelines are important for filing ICSRs to maintain the objectives of pharmacovigilance which is to ensure the safety of patients/volunteers during the process of clinical trials through adequate data collection, ordered data compilation and timely reporting of events that have the potential to …

What do you report in pharmacovigilance?

Spontaneous Pharmacovigilance Reports

  • Individual Case Safety Report (ICSR)
  • Case medical information inquiries.
  • Product complaints.
  • Reports from medical representatives.
  • Reports from competent authorities.
  • Contractual partners (co-marketed products, in-licensing, out-licensing, and distribution partners).

What is regulatory clock start date?

The regulatory reporting time clock is considered to start on the date when any personnel of the MAH first receive a case report that fulfills minimum criteria as well as the criteria for expedited reporting. In general, this date should be considered day 0.

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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.

What expedited reporting?

Expedited reporting of reactions which are serious but expected will ordinarily be inappropriate. Expedited reporting is also inappropriate for serious events from clinical investigations that are considered not related to study product, whether the event is expected or not.

What is safety reporting due date?

Unexpected fatal or life-threatening suspected adverse reactions represent especially important safety information and must be reported to FDA as soon as possible but no later than 7 calendar days following the sponsor’s initial receipt of the information.

What are the types of reports in pharmacovigilance?

What is the ICSR reporting timeline for a case?

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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.

What is the ICSR process?

ICSR Process is a part of the Pharmacovigilance Process . Individual Case Safety Report (ICSR) refers to the format and content for the submission of an individual report of suspected adverse reactions in relation to a medicinal product that occur in a single patient at a specific point of time. ( GVP Guidelines)

What action can regulatory authorities take based on ICSR reports?

Based on the reports (ICSR, DSUR and PSUR), regulatory authorities may take actions such as; Requesting that drug companies update the information in the drug’s label Conduct additional risk assessment or minimization activities.

How long does it take to submit a SUSAR ICSR?

7-Day Timeline:Any SUSAR ICSR with either “Death” or “Life Threatening” as seriousness criteria in the case should be submitted to regulatory authority within 7-day timeline period.