National level

PPB has the mandate to control the manufacture, sale, advertisement and possession of medicines.  PPB deals with provisions for trading, compounding, labelling, and recording medicine sales.  They issue licenses to applicants in the various fields i.e., wholesale, distribution, retail practice, etc.

The commercial pharmaceutical sector in Kenya is regulated by the following Bills:

The Public Health Act of 1961(CAP 242)

The Pharmacy and Poisons Act (CAP 244),

The Food, Drugs and Chemical Substances Act of 1965

·           The Narcotic Drugs and Psychotropic Substances Act of 1994

·           The Health Bill

·           Kenya National Drug Policy

·           The Pharmacy Practitioners Bill    

The Health Bill that is currently in Parliament shall repeal the Public Health Act if approved.  The Health Bill will change the pharmaceutical regulatory framework, whereby a Health Professional Oversight Authority and a Food and Drugs Authority will be enacted.  Thus, regulation of pharmaceutical practice will be separated from regulation of products, which is the standard practice in the United States of America.  At present, the government oversees all of these functions through the PPB. On the ground, pharmaceutical inspectors, employed by PPB enforce regulation in the retail sector.

Recently, the Public-Private Partnership Act was enacted to institutionalize the engagement of the private sector.[1]  The commercial pharmaceutical sector is attracting private sector involvement. KHF and KEPSA both act as the voice of the private sector that promotes private public dialogue at various forums including the Presidential Round Table.

Currently, medical equipment is regulated by the Pharmacy and Poisons board.  The guidelines for registration have been drafted but await approval (since last year and expected to be finalized in 2017).  Some cross regulation exists with the Nursing Council and Kenya medical Laboratory and Technicians board. This should however be resolved with the implementation of the Health Bill.

There is a requirement pending approval for Medical devices to also go through product registration process.[2]

There are annual costs involved with registrations and listing of medical devices with each of the boards.

The testing for quality of some devices is currently been carried out by NQCL, MEDS, and Kenya Bureau of Standards (KEBS).

Regional Level: East African Community Harmonization

The East African Community - Medicines Regulatory Harmonization (EAC-MRH) programme was launched in 2012.  Its main objective was to provide a joint assessment and approval system for approval of medicinal product applications for registration and inspection of medicine manufacturing sites.  This was to be integrated into the national regulatory framework.

Partners to the EAC - MRH program include NEPAD, WHO, World Bank, Trademark EA, Bill & Melinda Gates Foundation (BMGF).

The programme has set out EAC harmonized guidelines that include: Procedure for Marketing Authorization, Documents for Medicines Evaluation and Registration, Quality Management Systems, and Guidelines on Good Manufacturing Practices.

    On discussions with the Pharmacy and Poisons Board, it was confirmed that EAC Harmonization is on its way to establishing an agreement.  Currently 47 drug dossiers are approved between the countries, as reported by PPB officials.  There are 5 countries in the EAC and each must agree on the same.  The agreement is currently being reviewed.  Each County has its own regulatory and practice laws and standards.  The process of EAC Harmonization is now in sight.

[1] Government of Kenya, 2013

[2] For more details please visit www.pharmacyboardkenya.org.