The Department of Pharmacovigilance

The Department of Pharmacovigilance was set up in late 2004 at the Pharmacy and Poisons Board with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya. 

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems with the view to:
Early detection of hitherto unknown adverse reactions and interactions
Detection of increases in frequency of (known) adverse reactions
Identification of risk factors and possible mechanisms underlying adverse reactions
Estimation of quantitative aspects of benefit/risk analysis and dissemination of information needed to improve drug prescribing and regulation.

Pharmacovigilance Forms (for Manual Reporting)

Circular - PvERS II

The ultimate goals of Pharmacovigilance are:

  1. The rational and safe use of medicines
  2. The assessment and communication of the risks and benefits of drugs on the market
  3. Educating and informing patients.

Guidelines and the tools to implement Pharmacovigilance in Kenya have been developed and sensitization workshops have been carried out for various cadres of health professionals in Kenya such as Pharmacists, Pharmaceutical technologists, nurses, Clinicians and Clinical officers. The system plans to cover all provinces, for all medicines and for all patients. All manufacturers and distributors are expected to submit all findings and reports on adverse events with drugs to PPB.

Pharmacovigilance Notice
Notice to all Pharmacovigilante

Guidelines on the Safety and Vigilance of Medical Products and Health Technologies 2019
Guidelines for Establishment of the Qualified Persons for Pharmacovigilance
Guidelines for Monitoring Reporting and Managing Adverse Events Following Immunization (AEFI) in Kenya


Pharmacovigilance July-September 2020 Q1 Report
Pharmacovigilance April-June 2019 Q4 Report
Pharmacovigilance January-March 2019 Q3 Report
Pharmacovigilance October-December 2018 Q2 Report
Pharmacovigilance July-September 2018 Q1 Report 
Pharmacovigilance January-March 2018 Q3 Report 
Pharmacovigilance October-December 2017 Q2 Report
Pharmacovigilance July-September 2017 Q1 Report