ANNUAL REPORT 2021/2022
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ANNUAL REPORT 2021/2022
The Pharmacy and Poisons Board, under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya is mandated to regulate the profession of Pharmacy, the manufacture and trade in medical products and health technologies through regulation of marketing authorization, licensing, market control, ensuring product safety, clinical trials oversight, manufacturing and pharmacy practice. This means creating confidence among the public about the Health Products they consume, the regulatory agencies in the region in support of harmonization and adoption of international best practices. The Board’s financial year was marked by intense workload and efforts towards attainment of WHO Assessment rating of Maturity Level 3. This process has contributed immensely to regulatory systems strengthening and improvement of service delivery, which is summarized in this CEOs Annual Report FY 2021/2022. The WHO assessment came about the same time the country was preparing to establish vaccine manufacturing and capacity building in vaccine assessment and testing. This period also presented uncertainty around political transition in the country and economic recession affecting the whole world brought about mainly due to the COVID-19 Pandemic with disruptions in health care service delivery.
In spite of this the Board is delighted to highlight the major milestones in advancing its regulatory system notably; enactment of rules to better implement the Pharmacy and Poisons Act, the WHO assessment against the Global Benchmarking Tool (GBT), development of collaboration framework to guide cooperation with other government agencies and training of staff in vaccine regulation and testing.
To further strengthen governance, the first Board of Directors following amendment of the Pharmacy and Poisons Act was appointed in March 2022 and inauguration planned for 1st July 2022. In terms of legislative framework, the Board developed six sets of Pharmacy and Poisons Rules, 2022 that were enacted by Parliament in June 2022 to implement, interpret or prescribe the Pharmacy and Poisons Act.
In its effort to keep abreast with international initiatives and emerging trends, the Board participated in workshops, conferences and meetings organized both nationally and internationally; international workshop in Vienna for piloting an Online system for the control of Narcotics and psychoactive substances coordinated by the International Narcotics Control Board, WHO/AVAREF Safety Updates Meeting in Addis Ababa, Vaccine Manufacturing in South Korea,
The last financial year has seen concerted efforts from the Board of Management, government agencies and development partners in achieving the goals of regulation through collaborative efforts and financial support respectively. To this end, the Board sincerely appreciates the contributions from the stakeholders, the development partners, and the World Health Organization for being part of the success registered in the period.
During the same period, the Board conducted Post- Marketing Surveillance of maternal, neonatal and child health products and antimalarials in Kenya, 2021/2022. The Risk Based PMS samples were collected from 17 counties across the country. The total number of samples collected were 285, 176 tested and two (2) samples failed labeling requirements
Since the development and implementation of an online examination management system, in 2020, five series (20 sets) of online examinations have been successfully conducted with regard to Registration and Enrolment examination.
The Board prides itself in the improvement of the security, integrity, and efficiency of the online exam system due to the incorporation of Safe Exam Browser, and integration with the Regulatory Human Resource Information system (RHRIS) in the FY 2021-22. Consequently, automation has led to improved efficiency in exam administration as evidenced by a significant reduction in the time taken to release results. In addition, there has been Improved objectivity due to automated marking.
Further, exam administration has been decentralized, improving service delivery at regional level, improving access and fairness, while using resources within the PPB regional offices.
The Board endeavors to improve its regulatory system through benchmarking with WHO, regional economic Communities, internal audits, quality audits and through performance contracting and submits quarterly reports on its performance and activities to the Cabinet Secretary and Principal Secretary at the Ministry of Health. The Board ensures implementation of the commitments set out in the Annual President’s Report on National Values and Principles of Governance and report and the current rating is at 100%. The services at the Board are funded through funds collected as levies and donor funds. The Boards’ Internal Audit Unit ensures effective internal control in the use of internal resources.
In conclusion, I wish to thank the Board of Management, the management team, all staff members and stakeholders for their invaluable support without whom these achievements wouldn’t be possible.
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