Issued by: Pharmacy and Poisons Board (PPB), 14 August 2026
The PPB has introduced a Concurrent Submission Pilot Framework for clinical trial applications. It lets applicants submit the same application to the PPB and to a participating ethics committee within five working days of each other, so the regulatory and ethical reviews run in parallel.
Participating ethics committees
- KEMRI Scientific and Ethics Review Unit (SERU)
- MTRH Institutional Research and Ethics Committee (IREC)
What applicants do
- Submit the complete application to a participating ethics committee and keep evidence of submission.
- Submit the same application to the PPB within five working days, and give the ethics committee evidence of that submission.
- Respond to queries from both reviewers.
- Send any amended documents to both.
- Send the final ethics decision to the PPB once the ethical review is complete.
Ethics approval is still required. The PPB issues final authorization only after it receives the ethics approval or recommendation and completes its regulatory review.
Other ISERCs: the pilot applies only to the two committees above. Applicants using other committees should confirm the process with the PPB.
Source: Pharmacy and Poisons Board. See also the PPB Clinical Trials page.