PPB GMP Reliance and Recognition Checker
Select the regulatory authority or country that approved your product or manufacturing site, and find out whether Kenya's Pharmacy and Poisons Board is likely to accept it under a reliance pathway that can shorten registration and may avoid a separate physical GMP inspection.
Pick the authority that registered your product or approved your manufacturing site.
Reliance lists are updated by the PPB. Confirm the current position with us before relying on it.
Result
Reliance verdict
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What this means
What this means for your timeline and cost
Select an authority and check to see whether the PPB is likely to accept it under a reliance pathway.
GMP reliance and recognition: FAQ
What is regulatory reliance?
Reliance is when one regulator, such as Kenya's PPB, uses the assessment, approval, or inspection work already done by a trusted authority instead of repeating it from scratch. It reduces duplication, speeds up registration, and can avoid a separate physical GMP inspection when the source authority is one the PPB recognises.
Does the PPB recognise US FDA or EMA approval?
The PPB commonly relies on approvals from Stringent Regulatory Authorities, which include the US FDA and the European Medicines Agency and EU national authorities, as well as WHO Prequalification and the WHO Collaborative Registration Procedure. Products cleared by these bodies are usually strong candidates for a reliance pathway, though you still submit a Kenya dossier.
Is China NMPA or India CDSCO recognised by the PPB?
China's NMPA and India's CDSCO are not on the PPB's standard reliance list. That does not block registration, but you should plan for a full independent assessment and, potentially, a GMP inspection or a WHO GMP certificate route. The evidence you provide and the expected timeline change accordingly.
Does reliance mean I skip registration?
No. Reliance reduces duplication, it does not remove the requirement to register. You still submit a Kenya dossier to the PPB and pay the applicable fees. What reliance changes is how much of the technical review and inspection is repeated, which is where the time and cost savings come from.
Disclaimer: Reliance lists are updated by the PPB. Confirm the current position with us before relying on it. This tool is a planning aid, not a regulatory determination.
How PPB reliance and GMP recognition work
When a manufacturer based outside Kenya wants to register a medicine, the Pharmacy and Poisons Board has to be satisfied that the product is safe, effective, and made to Good Manufacturing Practice. One way to prove that is a full independent assessment plus a physical inspection of the factory. That is thorough, but it is also slow and expensive. Reliance offers a faster route: where a product or site has already been approved by an authority the PPB trusts, the Board can lean on that work rather than repeating it.
The authorities the PPB tends to recognise are the Stringent Regulatory Authorities, including the US FDA, the European Medicines Agency and EU national bodies, Health Canada, Swissmedic, Japan's PMDA, Australia's TGA, and the UK's MHRA. Alongside these sit the WHO reliance frameworks, namely WHO Prequalification and the WHO Collaborative Registration Procedure, and the regional East African Community harmonisation work through which neighbouring authorities such as Tanzania's TMDA and Uganda's NDA feed into shared assessments. Approval by any of these is usually a strong basis for a reliance pathway.
Authorities that are not on the standard reliance list, such as China's NMPA and India's CDSCO, are not shut out. Registration is still possible, but the PPB will generally expect a full assessment and may require a GMP inspection or a valid WHO GMP certificate to confirm manufacturing quality. The practical difference is the evidence you must assemble and the time it takes. Knowing which bucket your approving authority falls into early lets you plan the dossier, the budget, and the timeline before you commit.
How to use this checker
Select the approving authority
Choose the regulator or country that registered your product or approved your manufacturing site. The list is grouped into recognised authorities and those not on the standard reliance list.
Read the verdict
The tool tells you whether the PPB is likely to accept a reliance pathway or whether to plan for a full assessment, along with what it means for your evidence, timeline, and cost.
Confirm the current position
Reliance lists change. Talk to a regulatory pharmacist to confirm the current PPB position for your specific product before you build the dossier or book an inspection.
Not sure which pathway applies to your product?
We map your approving authority to the fastest compliant PPB route, assemble the Kenya dossier, and act as your Local Technical Representative if you manufacture outside Kenya.