The Health Products and Technologies Regulatory Authority Bill is still a bill, not an Act, but it is a bill worth planning around now. It would abolish the Pharmacy and Poisons Board entirely and replace it with a single regulator covering a far wider range of products than the PPB ever did, and it is currently sitting at Second Reading in the Senate after clearing the National Assembly.
Where the Bill Actually Stands
The Bill began as the Kenya Drugs Authority Bill, 2022, sponsored by Hon. Robert Pukose, and was renamed along the way to the Health Products and Technologies Regulatory Authority Bill. It passed the National Assembly in November 2024 and was forwarded to the Senate in December 2024, where it has been sitting at Second Reading. It has not passed the Senate, received presidential assent, or been gazetted into law. A company relying on this article for compliance planning should check the Senate’s own Bills Tracker for the current stage before treating any provision below as settled law, since the text can still change before final passage.
The PPB Does Not Survive This Bill
The Bill repeals the Pharmacy and Poisons Board Act, Chapter 244, along with sections 16 to 18 of the Narcotic Drugs and Psychotropic Substances Act, and abolishes the PPB outright rather than renaming or absorbing it into a subsidiary role. A transitional clause moves the PPB’s assets, liabilities, existing agreements, and pending proceedings to the new Kenya Health Products and Technologies Regulatory Authority, and staff of both the PPB and the National Quality Control Laboratory transfer to the new Authority. For a company with a live PPB registration, licence, or pending application, this transition mechanism is the provision to watch most closely once the Bill’s final Senate text is available, since it determines whether existing approvals carry over automatically or require re-registration.
A Much Wider Scope Than the PPB Ever Had
The new Authority’s jurisdiction extends well beyond conventional pharmaceuticals. The Bill brings medicines, medical devices including radiation-emitting devices, radiopharmaceuticals, complementary and herbal medicines, cosmetics and borderline products, in-vitro diagnostics, therapeutic feeds, clinical trials, nutraceuticals and dietary supplements, digital health technologies, scheduled and chemical substances, and biological products all under one regulator. A diagnostics company or a digital health platform that has never dealt with the PPB because its products fell outside pharmaceutical regulation would, under this Bill, fall squarely within the new Authority’s licensing and enforcement powers for the first time.
Licensing Powers and Penalties
The Authority would issue, suspend, and revoke licences for manufacturers, wholesalers, retailers, importers, exporters, and distributors of the products within its scope, with registration conditioned on the Authority being satisfied as to safety, efficacy, quality, performance, and economic value. The Bill sets out its own penalty scale distinct from the PPB’s current regime under Cap 244: manufacturing without a licence carries a fine of up to KES 10 million, imprisonment of up to ten years, or both; falsifying records or products carries up to KES 5 million or five years; and import violations carry up to KES 2 million or five years. The full detail of the Authority’s Board composition and governance structure was not fully available in the summary materials reviewed for this article and should be confirmed against the complete Bill text or the Senate committee’s own report before being stated as settled in client advice.
What This Means for Planning Now
A life sciences or health-tech company operating in Kenya today should not restructure its regulatory approach around this Bill before it passes, since Senate text can still change and the Bill has not been enacted. What is worth doing now is mapping which of a company’s products would newly fall within the Authority’s broadened scope, particularly medical devices, diagnostics, and digital health technologies that currently sit outside PPB jurisdiction, and watching the transitional provisions closely once Senate passage is confirmed, since those provisions will determine whether existing PPB approvals need to be re-established under the new Authority.
The consolidation model this Bill follows is not unusual on the continent; several African regulators have moved toward single-authority structures covering medicines, devices, and diagnostics together rather than maintaining separate regimes for each. What makes Kenya’s version worth tracking closely is the breadth of the transitional clause: because it moves the PPB’s staff, assets, and pending proceedings wholesale rather than winding the PPB down gradually, a company with an application currently pending before the PPB should ask, once the Senate text stabilizes, whether that specific application would be treated as pending before the new Authority automatically or would need to be resubmitted under the Authority’s own procedures.
How We Can Help
Clay & Associates Advocates tracks pending Kenyan health-sector legislation for life sciences and health-tech clients and advises on how to prepare for regulatory transitions before they take effect. Our guide to fast-track drug registration under the current PPB regime is a useful companion for understanding what this Bill would ultimately replace. Contact our Life Sciences & Healthcare practice to assess how this Bill would affect your current regulatory approvals if enacted.
Sources: Health Products and Technologies Regulatory Authority Bill (originally the Kenya Drugs Authority Bill, 2022), National Assembly Bill Digest (February 2025) and bill text (Kenya Law); Senate of Kenya Bills Tracker; Pharmacy and Poisons Act, Chapter 244, Laws of Kenya; Narcotic Drugs and Psychotropic Substances Act, sections 16 to 18.
Frequently asked questions
Has the Health Products and Technologies Regulatory Authority Bill become law?
No. As of this writing it has passed the National Assembly and is at Second Reading in the Senate. It has not passed the Senate, received presidential assent, or been gazetted.
Does this Bill abolish the Pharmacy and Poisons Board?
Yes, if enacted in its current form. It repeals the Pharmacy and Poisons Board Act outright and transfers the PPB’s assets, staff, and pending matters to the new Authority, rather than preserving the PPB in any form.
Will medical device and diagnostics companies be newly regulated under this Bill?
Yes. The Bill’s scope explicitly includes medical devices, in-vitro diagnostics, digital health technologies, and several other product categories that fall outside the PPB’s current jurisdiction under Cap 244.
Should I change my regulatory strategy now because of this Bill?
Not based on the Bill alone while it remains unpassed. It is worth mapping which products would newly fall within the Authority’s scope so you are prepared once Senate passage and assent are confirmed.
