Usage Examples
- The 15-day clock started when the call centre logged the report, not when it reached our pharmacovigilance database.
- Pharmacovigilance has to be inspection-ready before the EU filing, not after it.
- We cannot file in the EU without a QPPV who both resides and operates in the Union.
What is Pharmacovigilance (PV)?
Pharmacovigilance is the regulated safety discipline covering detection, assessment, understanding, and prevention of adverse drug reactions, and the reporting obligations that bind sponsors during trials and marketing authorisation holders for as long as a product stays on the market.
Pharmacovigilance exists because a marketing authorisation is granted on trial data from a few thousand selected patients, while rare, delayed, and interaction-driven harms only appear once millions of ordinary patients take the drug. Pharmacovigilance is the regulatory answer to that gap: a standing obligation to keep collecting, assessing, and reporting safety information after approval, enforced through fixed reporting deadlines rather than left to the sponsor's judgement.
Pharmacovigilance covers individual case safety reports, signal detection, benefit-risk evaluation, periodic safety reporting, risk management planning, and the labelling changes that follow from them. Pharmacovigilance under 21 CFR 314.80 applies to marketed products; investigational-phase safety reporting sits under 21 CFR 312.32 and runs on different clocks. Product quality complaints with no associated adverse drug experience stay with the quality system, not pharmacovigilance.
Pharmacovigilance is applied as a case-processing pipeline running against fixed clocks. Pharmacovigilance staff date-stamp every intake, because 21 CFR 314.80(c)(1)(i) measures its 15 calendar days from initial receipt of the information by the applicant, then assess whether the case is both serious and unexpected against the current labelling. Pharmacovigilance records, including raw data and correspondence, are retained for 10 years.
Not to be confused with
- Adverse Event
- an adverse event is a single observed occurrence in one patient. Pharmacovigilance is the system that intakes, assesses, reports, and acts on those occurrences across the whole product.
- Signal Detection
- signal detection is one activity inside pharmacovigilance: the review that flags a possible new causal association. Pharmacovigilance also covers case intake, expedited reporting, risk management, and labelling change.
- PSUR
- a PSUR is a periodic deliverable produced by a pharmacovigilance system, not the system itself. Treating the report as the obligation is what turns continuous surveillance into a submission deadline.
- RMP
- a risk management plan documents the specific measures taken for one product's known and potential risks. Pharmacovigilance is the surveillance discipline that generates the evidence an RMP is built on and updated from.
Pharmacovigilance obligations attach to the applicant or marketing authorisation holder, not to the vendor of the safety database.
What you must do
- 1Report each adverse drug experience that is both serious and unexpected no later than 15 calendar days from initial receipt of the information by the applicant21 CFR 314.80(c)(1)(i)
- 2Promptly investigate every case that is the subject of a postmarketing 15-day Alert report and submit follow-up reports within 15 calendar days of receiving new information21 CFR 314.80(c)(1)(ii)
- 3Maintain records of all adverse drug experiences known to the applicant, including raw data and correspondence, for 10 years21 CFR 314.80(j)
- 4Submit the annual report within 60 days of the anniversary date of U.S. approval, including a brief summary of significant new information that might affect safety, effectiveness, or labeling21 CFR 314.81(b)(2)
- 5During clinical development, notify FDA of any unexpected fatal or life-threatening suspected adverse reaction within 7 calendar days, and file IND safety reports for other qualifying events within 15 calendar days21 CFR 312.32(c)(1) and (c)(2)
- 6For EU products, operate a pharmacovigilance system under a QPPV who both resides and operates in the Union, and keep the pharmacovigilance system master file where the QPPV operates or where the main pharmacovigilance activities are performedEU GVP - QPPV and PSMF
Common mistakes
Applying the 7-day clock to postmarketing cases
The 7 calendar day notification belongs to IND safety reporting for unexpected fatal or life-threatening suspected adverse reactions [21 CFR 312.32(c)(2)]. Postmarketing serious and unexpected cases run on a single 15 calendar day clock [21 CFR 314.80(c)(1)(i)]. One SOP written for both either burns resources on phantom postmarketing deadlines or files an IND fatality eight days late.
Starting the clock at case entry instead of receipt
21 CFR 314.80(c)(1)(i) runs from initial receipt of the information by the applicant, not from the date the case reaches the safety database. Days lost in a call centre queue, a distribution partner's inbox, or a medical information mailbox come out of the 15, and the timestamps that prove it sit in the company's own systems.
Purging case files on the general IT retention schedule
21 CFR 314.80(j) requires 10 years of records of all adverse drug experiences known to the applicant, including raw data and correspondence. A generic five or seven year email and log retention policy destroys exactly the evidence an inspector uses to test whether the 15-day clock was met, and the absence of the record is itself the finding.
When This Matters
- The 15-day clock started when the call centre logged the report, not when it reached our pharmacovigilance database.
- Pharmacovigilance has to be inspection-ready before the EU filing, not after it.
- We cannot file in the EU without a QPPV who both resides and operates in the Union.
Frequently Asked Questions
Pharmacovigilance and drug safety are used interchangeably in most companies, with pharmacovigilance being the broader term. Pharmacovigilance names the whole discipline, including signal detection, risk management, and benefit-risk evaluation; drug safety usually names the operational case-processing function that intakes, codes, assesses, and submits individual case safety reports to regulators.
