Get PPB approval to run a clinical trial in Kenya
Pharmacy and Poisons Board · sources read 3 Oct 2026
Get a favourable opinion from a NACOSTI-accredited ethics committee first, then submit your application, documents and fee online on PPB's Clinical Trials Registry (ctr.pharmacyboardkenya.org). PPB aims to reply within 50 working days of a complete application.
- Fee
- USD 1,000 (or the same in KSh) per protocol, paid by banker's cheque. It isn't refunded.
- How long
- Up to 50 working days after PPB receives a complete, valid application
- Where
- Online on PPB's Clinical Trials Registry (ctr.pharmacyboardkenya.org)
What you need
- Cover letter and the study protocol
- Patient information leaflet and consent form in English, Kiswahili and the local languages you will use
- GMP certificate of the investigational product from its manufacturing site, and its certificate of analysis
- Favourable opinion letter from the ethics review committee (ERC)
- Insurance certificate for the study participants
- Proof of recent GCP training for the core study staff
- Registration of the study on the Pan African Clinical Trials Registry (pactr.samrc.ac.za)
Steps
- Get ethical clearance for the study from a NACOSTI-accredited ethics review committee (ERC).
- Register on ctr.pharmacyboardkenya.org and submit the application with all the checklist documents. PPB screens it for completeness first.
- Pay the non-refundable application fee of US$ 1,000 (or the Kenya shilling equivalent) per protocol, by banker's cheque to “Pharmacy and Poisons Board”.
- When the application is accepted you get an ECCT reference number. Quote it in all later correspondence.
- Wait for PPB's written decision: approval, a request for more information, or rejection with reasons.
Watch out
- Approval is not one-off: every ongoing trial must apply for annual approval on the same portal.
- Answer PPB's queries within the set time, or the application lapses and you may have to apply again.
- You can only get approval to import the trial product after the trial itself is approved.
Who can apply
- Anyone planning a study that tests medicines, vaccines or medical devices on people needs PPB approval first
- The application is made by the sponsor, the sponsor's representative or the principal investigator
Official sources (2)
- Guidelines for the Conduct of Clinical Trials in Kenya (Rev. 06, June 2026) web.pharmacyboardkenya.org · read 3 Oct 2026
- Clinical Trials Registry ctr.pharmacyboardkenya.org · read 3 Oct 2026