The Data Lock Point and Reporting Interval

Every PBRER has to answer a question that sounds almost too basic to need an answer: as of when, exactly, is the data in this report current? Pharmacovigilance data accumulates continuously — cases arrive daily, signals evolve, literature gets published — and without a defined cutoff, a report attempting to reflect "everything known as of right now" could never actually be finalised, because there would always be a new case that arrived after the writing started. The Data Lock Point (DLP) is that defined cutoff: the specific date after which no additional case data gets included in that particular report.

Once the DLP is set, a clock starts running toward submission — commonly 70 calendar days from the DLP for the initial submission in most major regions, occasionally extended to 90 days under specific regional or product-type circumstances. That timeline exists to balance two competing needs: giving the report authors enough time to actually compile, review, and finalise a document this comprehensive, while still keeping the information reasonably current by the time a regulator actually receives it.

Reporting intervals themselves typically follow a defined recurring schedule, anchored to the product’s International Birth Date (IBD) — the date of its first marketing authorisation anywhere in the world, regardless of when it was authorised in any specific region being reported to. This is part of what makes PBRER genuinely globally harmonised in the way Lesson 8.2 described: a single interval schedule, anchored to one global reference date, rather than each region running its own independently-scheduled reporting cycle for the same product.

A case that arrives one day after the DLP isn’t lost or discarded — it simply becomes part of the next reporting interval’s data instead of the current one. This is exactly why cumulative review matters as much as interval-specific review throughout the PBRER: a pattern that started emerging just before one DLP and continued just after it needs to be visible across both intervals, considered together, not artificially split by an administrative cutoff date that has nothing to do with the underlying clinical reality.