Kenya Profile Updated

July 2, 2024
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The Kenya profile in ClinRegs has been reviewed and updated with the following information:

  • Minor revisions to the Pharmacy and Poisons Board (PPB) guidance for the conduct of clinical trials, including an updated definition of investigational product, name change for the PPB clinical trial division, and renumbered sections (See the Submission Process, Timeline of Review, and Definition of Investigational Product sections)
  • Updated National Commission for Science, Technology and Innovation (NACOSTI) instructions on paying for a research license and using the online payment platform, eCitizen (See the Regulatory Fees section)
  • PPB guidance on a standardized approach for evaluating and reporting the balance between the benefits and risks of health products during clinical trials (See the Risk & Quality Management section)
  • Details on Kenya’s research information system (KENRIS) which supports researchers, institutions, and ethics committees (See the Oversight of Ethics Committees and Site/Investigator Selection sections)
  • PPB guidance on good manufacturing practices (See the Manufacturing & Import section)

Sources Added During this Update:

(Guidance) Guideline on Benefit-Risk Assessment of Health Products and Technologies (Rev. No. 0) (Bft-Risk) (January 2023)
Pharmacy and Poisons Board

(Guidance) Kenya Good Manufacturing Practices Guidelines (Rev. No. 1) (KenyaGMP) (April 2023)
Pharmacy and Poisons Board

(Webpage) eCitizen Login Page (KEN-12) (Current as of July 2, 2024)
Government of Tanzania

(Webpage) Kenya National Research Information System (KENRIS) Login Page (KEN-23) (Current as of July 2, 2024)
National Commission for Science, Technology and Innovation

(Webpage) Newly Accredited ISERCs in Kenya (KEN-38) (Last Updated May 11, 2023)
National Commission for Science, Technology and Innovation

Sources Revised During this Update:

(Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (Rev. No. 4) (G-KenyaCT) (Effective October 1, 2022)
Pharmacy and Poisons Board

(Webpage) Application for a Research License (KEN-31) (Current as of July 2, 2024)
National Commission for Science, Technology and Innovation

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