PPB PSUR Submission Requirements & Timelines

Periodic Safety Update Reports (PSURs), aligned with the ICH E2C(R2) PBRER format, follow a structured submission cadence that changes as a product matures on the Kenyan market.

The standard PSUR cycle

• Every 6 months for the first 2 years after authorization
• Annually for years 3 through 5
• Every 3 years after that, unless the PPB specifies otherwise for a particular product

Why this timeline trips up MAHs with large portfolios A single-product company can track this on a calendar. A MAH with a 100+ product portfolio, each on a different authorization date, is tracking dozens of independently-moving deadlines simultaneously — and a missed submission doesn't announce itself until an inspection or a renewal application surfaces the gap.

What's actually required in a PSUR Beyond the safety data itself, PPB expects the report to reflect ongoing benefit-risk evaluation, not just a log of adverse events — meaning literature monitoring and signal evaluation need to feed into the document, not sit in a separate silo.

See how PvSentinel auto-tracks PSUR deadlines across your entire product portfolio.

PPB's pharmacovigilance guidelines

FAQ

What happens if a PSUR deadline is missed? It can contribute to registration suspension or refusal of renewal, per PPB guidelines on non-compliance. Does the PSUR clock reset if I get a variation approved? Generally no — the clock runs from original authorization unless the PPB directs otherwise for that product.