ANNUAL REPORT 2020/2021
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ANNUAL REPORT 2020/2021
The Pharmacy and Poisons Board (the Board) Financial Year 2020/21 CEO’s Annual Report outlines the Board’s achievements, which, despite the Covid-19 Pandemic, recorded the highest number of innovative approaches in ensuring business continuity. Significantly, was the successful development and implementation of an online examination management system which resulted to administration of two series (8 sets) of online examination. The exam administration was decentralized from one center in 2019 (manually administered examination) to ten (online examinations) in July 2021. Due to online administration of exams, the Board registered improved efficiency with significant reduction in time taken to release results and optimal utilization of resources due to automated marking.
With a view of aligning Pharmacovigilance to international best practices, the Board, upgraded and launched in March 2021 Kenya Pharmacovigilance Electronic Reporting System (PvERS) version II. The system aims at strengthening reporting of suspected Adverse Drug Reactions and Events related to health products and health technologies.
The Board witnessed an improvement in the various regulatory functions. In particular, dossier evaluation was intensified with reduced registration timelines from approximately 3 years to 15 months. In support of the local pharmaceutical production and in line with the H.E President Big Four Agenda, the Board was able to recommend registration of 53 locally manufactured products through fast-track mechanism. The Emergency Use Authorization pathway and various committees were also introduced in registration process as well as use of reliance and recognition of WHO Emergency Use Listed products in responding to COVID-19 pandemic.
Similarly, the Board expanded the scope of products surveyed under the Joint Post Marketing Surveillance of products for HIV, TB, Malaria and Reproductive Health.
The Department of Inspectorate and Enforcement in an effort to ensuring compliance with regulations and the Law in order to protect and maintain the integrity of the Health Products and Technologies supply chain, conducted routine compliance inspections of the licensed pharmaceutical premises among other activities to reduce incidences of violations. In the same period, there was an increase in the number of Desktop Document reviews of Foreign manufacturing facilities for Health Products and Technologies.
There was a roll out of a new Trade Facilitation Platform (TFP) which is an enhanced format of the previous single window system in conformity to the WTO Kyoto conventions of trade facilitation. The TFP integration with Kenya Revenue Authority (KRA) Custom Management System (iCMS) has improved the Board visibility at the Ports of Entry. Since the automation of the TFP, there was an increase of import permit application in the last 2 months of the year 2021 which represented a revenue increase of 7.35% in 2020/2021 as compared to 2019/2020 FY.
The Board participates in performance contracting and submits quarterly reports on its performance and activities to the Cabinet Secretary and Principal Secretary at the Ministry of Health. Consequently, the Board ensures implementation of the commitments set out in the Annual President’s Report on National Values and Principles of Governance and report.
Finally, the services at the Board are funded through financial support from the mother Ministry, Ministry of Health, funds collected as levies and donor funds and it ensures effective internal control in the use of internal resources through Internal Audit Unit and Auditor General audits.
|PPB Annual report FY 2020_2021-2.pdf