Stage 0101
Can it be sold?
Approval
Getting a healthcare product legally onto the Kenyan market, and keeping the quality systems behind it inspection-ready.
- Regulatory strategy
- Submissions and eCTD
- Compliance and quality systems
Regulatory affairs and health technology assessment · Kenya and East Africa
Precision in healthcare.
Confidence in regulation.
Approval is no longer the finish line. We take healthcare products through registration with the Pharmacy and Poisons Board, and through the health technology assessment that decides whether the Social Health Authority will pay for them.
Approval
Market entry
Reimbursement
Lifecycle
02The pathway
From approval to funded access
Four stages. A product can pass the first and still fail commercially at the third, which is where most of the Kenyan market currently is.
Approval
Can it be sold?
- Regulatory strategy
- Submissions and eCTD
- Compliance and quality systems
Market entry
Can it reach the market?
- Multi-market dossiers
- Local adaptation
- Expedited pathways
ReimbursementNew capability
Will it be paid for?
- HTA dossiers
- Economic modelling
- SHA and BPTAP engagement
Lifecycle
Does it stay valuable?
- Post-approval monitoring
- Label expansion
- Portfolio strategy
SHA coverageSocial Health Insurance Act 2023
- 01
Primary Healthcare Fund
Primary healthcare services
- 02
Social Health Insurance Fund
Benefits at the tariff set for each service
- 03
Emergency, Chronic and Critical Illness Fund
Cover beyond the insurance benefit
Assessed byBenefits Package and Tariffs Advisory Panel
New capability · Stage 03
Registered is not the same as reimbursed.
Kenya replaced NHIF with the Social Health Authority under the Social Health Insurance Act 2023. What SHA pays for, and at what tariff, is shaped by health technology assessment through the Benefits Package and Tariffs Advisory Panel.
A product can be fully registered with the Pharmacy and Poisons Board and still sit outside the benefits package, competing on out-of-pocket price against a funded alternative. Closing that gap is a different discipline from registration, and it is the one we have built for.
Health product assessment and benefit listing04Services
What each stage delivers
Stage 0202
Can it reach the market?
Market entry
Taking a registered product into additional markets without rebuilding the dossier each time.
- Multi-market dossiers
- Local adaptation
- Expedited pathways
Stage 0303
Will it be paid for?
Reimbursement
New capabilityBuilding the evidence that supports inclusion in the national benefits package, so an approved product becomes a funded one.
- HTA dossiers
- Economic modelling
- SHA and BPTAP engagement
Stage 0404
Does it stay valuable?
Lifecycle
Sustaining a product's value after approval, from variations and renewals to broadening an approved indication.
- Post-approval monitoring
- Label expansion
- Portfolio strategy
05Practice
Why partners choose Ultra Pharma
Practical systems, in-country knowledge, and delivery models built to move healthcare products forward in Kenya and across Africa.
Outcome-driven submissions
We build dossiers around approval triggers: pre-submission audits, agency-ready narratives, and checklist-driven gap closure.
Why it matters
Fewer questions from regulators, shorter review cycles.
Rapid-response regulatory unit
A dedicated team that activates for urgent filings, regulatory queries, or inspection support.
Why it matters
Reduces stoppages and protects launch windows.
Local architects, regional reach
In-country specialists translate global standards into locally acceptable strategies, coordinating with partners and stakeholders on the ground.
Why it matters
Smoother market entry with fewer reworks.
Compliance by design
Quality systems, SOPs and traceable records integrated from the outset: digital-first, audit-ready, scalable.
Why it matters
Inspection resilience and lower remediation cost across the lifecycle.
Client-aligned commercial models
Milestone fees, retainer and milestone hybrids, or outcome-linked engagements tailored to project risk.
Why it matters
Aligns incentives and reduces upfront budget friction.
Capacity and knowledge transfer
Practical workshops, SOP handovers and on-the-job mentoring so your team gains autonomy.
Why it matters
Long-term capability, less reliance on external support.
06Proof
The people who do the work
Named leads with credentials, not a corporate history. Portraits and case notes go live when the firm supplies them.
JK
EO
AH
DK
07Insight
Regulatory and access analysis
Reimbursement6 min read
What the SHA benefits package means for a registered product
Coverage under the Social Health Authority flows through three funds. What that structure changes for a product that already holds Pharmacy and Poisons Board registration.
10 February 2026Read
Policy8 min read
Reading the BPTAP mandate: what the panel actually assesses
The Benefits Package and Tariffs Advisory Panel was gazetted in April 2025. What its published mandate covers, and what it does not.
22 January 2026Read
Approval5 min read
What actually drives a PPB review timeline
Review duration is mostly a function of dossier quality and query handling. Where the time goes, and which parts an applicant controls.
4 December 2025Read
08Contact
Talk to us
Regulatory guidance, a proposal, or rapid-response support on something already in motion.
We reply to enquiries within one working day.