This blog covers:
- What regulatory timelines are
- Key conventions to follow when working with regulatory timelines
- A breakdown of the major regulatory timelines you need to
Table of Contents
Introduction
In today’s regulatory environment, every product must adhere to specific timelines to ensure safety, reliability, and public trust.
In the field of drug safety, regulatory timelines play a critical role. They help ensure that safety data is reported and assessed promptly, minimizing risk to public health.
Meeting these timelines is not just important—it’s mandatory. Submissions must be made within designated timeframes based on defined regulatory criteria, making timeline compliance a key component of effective pharmacovigilance.
Regulatory Timelines: What and Why
In the context of pharmacovigilance, nearly every process is governed by regulatory timelines. In this section, we’ll explore those timelines and the important nuances associated with them.
All valid Individual Case Safety Reports (ICSRs)—from non-serious to serious cases—must be submitted within specific timeframes. However, the deadlines can vary depending on the case classification and applicable regulatory guidelines.
Timely submission of ICSRs is essential to ensure compliance and maintain public safety. Regulatory authorities require these timelines to be strictly followed for both domestic and international reporting.
Moreover, it’s not just ICSRs that are subject to timelines—aggregate reports (such as PSURs/PBRERs, DSURs, etc.) also have defined submission schedules that must be adhered to.
Requirements for Regulatory Submission
Regulatory submissions are essential for the review and evaluation of a product’s safety, as well as the overall benefit-risk balance of medicinal products.
Medicinal products have a profound impact on human health, and if not properly monitored, they can pose serious risks—even life-threatening consequences.
That’s why timely and accurate regulatory submissions are critical to ensuring patient safety and maintaining public health.
“In pharmacovigilance, time isn’t just a measure—it’s a mandate. Timely action safeguards lives and builds trust.”
Key Timelines to Keep an Eye On
In routine pharmacovigilance case processing, we typically deal with both serious and non-serious cases. Each category has its own regulatory timelines that must be followed. It is universally applicable, sometimes it may vary based on certain region.
Below, we’ll take a closer look at the timelines for serious and non-serious cases individually.
For Serious Cases
All expedited reports involving serious adverse events must be submitted as quickly as possible. Serious cases require expedited reporting and are typically categorized as serious expected and serious unexpected. The timelines below apply to both initial and follow-up reports.
Note: Expedited reporting does not always refer exclusively to serious adverse event reports.
- General Requirement: Submission of serious valid ICSRs must occur no later than 15 calendar days from the initial receipt of information by the national or regional pharmacovigilance center or a competent authority.
- Marketing Authorization Holders (MAHs): All serious adverse events must be reported by the MAH within 15 calendar days of receiving the information, regardless of the source.
- EU Literature Reports: Literature cases involving serious adverse events in the EU must also be submitted within 15 calendar days.
- Downgraded Serious Cases: These should be submitted within 15 calendar days initially, and then any subsequent follow-up reporting can follow non-serious case timelines.
- Country-Specific Variations: Some countries require expedited submission within 7 calendar days for death and life-threatening events—especially in the case of SUSARs (Suspected Unexpected Serious Adverse Reactions).
- U.S. FDA Requirement: The FDA mandates a “7-day IND safety report” for any unexpected fatal or life-threatening suspected adverse reactions.
For Non-serious cases
Non-serious cases refer to adverse events that do not meet the criteria for seriousness and are not subject to expedited reporting.
- General Requirement: All non-serious adverse events must be reported by the Marketing Authorization Holder (MAH) within 90 calendar days of receiving the information from any source.
- FDA Requirement: For U.S. FDA reporting, non-serious cases must be submitted within 60 calendar days.
For Literature reports
- Day Zero for Literature Reports: The reporting clock starts—known as day zero—on the date the reporter becomes aware of a publication containing the minimum criteria for a valid ICSR.
- It generally follows the two criteria mentioned above.
For PSUR (Periodic Safety Update Reports)
Each Marketing Authorization Holder (MAH) is responsible for submitting PSURs for their products and must follow the timelines below when submitting to the relevant authority:
- Within 70 calendar days from the Data Lock Point (Day 0) for PSURs covering intervals up to and including 12 months.
- Within 90 calendar days from the Data Lock Point (Day 0) for PSURs covering intervals longer than 12 months.
- For ad hoc PSURs requested by competent authorities, the submission timeline will typically be specified in the request. If not specified, the report must be submitted within 90 calendar days from the Data Lock Point.
Critical Conventions
- Downgrade from Serious to Non-Serious: If a case initially reported as serious is later reclassified as non-serious based on follow-up information, the reclassification must still be submitted within 15 calendar days. Subsequent follow-ups can then follow non-serious reporting timelines.
- Error Acknowledgement (ACK): If an ICSR is returned with an error ACK, the sender must correct and retransmit the case within the applicable regulatory timeframe.
- No Positive ACK Received: If no positive acknowledgement is received, the regulatory clock continues running. The ICSR must be corrected and retransmitted to EudraVigilance (EV) within the original regulatory deadline.
- Upgrade from Non-Serious to Serious: When a case is upgraded from non-serious to serious, it must be resubmitted according to the serious case timelines, starting from the date of upgrade.
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Key Takeaways
All regulatory timelines are based on calendar days, not business days.
Serious cases must generally be reported within 15 calendar days from the date of initial awareness.
The reporting clock resets upon receipt of additional clinically or medically relevant information for a previously reported serious adverse event.
Submission deadlines must be calculated using calendar days, regardless of weekends or public holidays—every day counts.
Conclusion
This write-up has highlighted important conventions and key details to help you understand and comply with regulatory timelines for different categories of cases. We recognize that navigating these requirements can sometimes be confusing.
To make it easier, we’ve broken down the information step-by-step for clear understanding. If you found this content helpful and it clarified your doubts, it may also benefit others in your network.
Please feel free to share this with your colleagues and friends to help spread awareness and promote best practices in pharmacovigilance.
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