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Post-Market Surveillance

Post-marketing surveillance of medical products and health technologies is a key regulatory function of the Pharmacy and Poisons Board. Post-marketing surveillance entails monitoring of the quality of medical products circulating in Kenyan market to check compliance with standards and / or specifications. It is aimed at prevention, detection and response to risks on quality of medical products in Kenya.

The Board has established the National Post-marketing surveillance system (PMS) that comprises different stakeholders with various roles and responsibilities. The key players include the general public, patients, healthcare providers, county vigilance focal persons, wholesalers, importers, market authorization holders, manufacturers, the quality control testing laboratories, the Board and the National Pharmacovigilance and post-marketing surveillance technical working group (PV/PMS TWG).

In addition, the Board has established the national reporting system for poor quality medical products and product related market complaints. The reporting system is both manual and electronic. The platform for online reporting is the pharmacovigilance electronic reporting system (PvERS) ; : https://pv.pharmacyboardkenya.org, which provides for reporting on the pink form.

There are two main approaches to PMS in Kenya, active and proactive post-marketing surveillance. 

These approaches incorporate risk-based strategy in their implementation.

  • Active PMS – conducted through evaluation of feedback from stakeholders, investigation of product related market complaints, reports of poor-quality medical products and subsequent implementation of regulatory actions.
  • Proactive PMS – Entails systematic, scientific and structured products quality surveys that are implemented based on PMS survey protocols which are developed by PV/PMS TWG.

The public is encouraged to be vigilant and report all suspected poor quality medical products to the Pharmacy and Poisons Board at: website: https://pv.pharmacyboardkenya.org, Email: pv@pharmacyboardkenya.org , Tel No. +254795743049