Kenya Endorsed as a Member Economy to the AHWP at the 22nd Asian Harmonization Working Party(AHWP) i← Back
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Kenya Endorsed as a Member Economy to the AHWP at the 22nd Asian Harmonization Working Party(AHWP) in New Dehli, India.
Dr Fred M Siyoi, Dr Paulyne W Kamau, Dr Dominic Munyoroku
Pharmacy and Poisons Board
Medical Devices including In-VItro Diagnostics as Vital Components to achieving Universal Health Coverage (UHC) for Kenya.
Medical devices including In vitro diagnostics constitute a vital component of health products and health technologies that contribute to the attainment of the highest standards of health for all citizens as envisioned in Article 43 of the Constitution of Kenya. Regulation of these products is key to attainment of this Human Right.
In Kenya, the enactment of The Health Act 2017 informs of a single regulatory authority that will oversee the regulation of Health Products and Technologies. The Pharmacy and Poisons Board, under CAP244 Laws of Kenya, has served as the National regulatory Authority for Kenya since 1957 when it was established.
Universal Health Coverage (UHC) as indicated by the Sustainable Development Goal (SDG) Three (3) is a right to every Kenyan Citizen as enshrined in the Constitution of Kenya.
Central to the achievement of Universal Health Coverage is the Strengthening of Regulatory process as called for in the World Health Assembly Resolutions 67.22 on ‘access to Medicines’ and Resolutions 67.20 ‘Regulatory System Strengthening for Medical Products’.
Achievements by the Pharmacy and Poison Board
Following these WHA recommendations, in 2010 the Pharmacy and Poisons Board was mandated to adopt the WHO global model regulatory framework for Medical Devices including In vitro diagnostics (IVDs); by constituting a department under the Directorate of Registration and Evaluation. Since then, Milestones in the areas of reviewing of all applications coming into the country, control of imports and exports, Pre-Verification of pre-shipments and the online submission of application have created both order and restored confidence amongst the key players who are Manufacturers/Importers and Exporters of Health products and Technologies.
Through the Online platform, the mapping of Medical equipments to all health facilities where they have been installed, the monitoring of safety updates, as-well as the provision of up to date records of the Medical Devices in the country has provided information of the regulatory landscape in Kenya, and provided crucial and significant data safeguarding the public health.
The International Medical Devices Regulators Forum (IMDRF) &Asian Harmonization Working Party (AHWP).
The International Medical Devices Regulators Forum (IMDFR), Formerly the Global Harmonization Task Force (GHTF) was constituted by founding member economies regulatory Authority with a view to harmonize fragmented regulatory system for Medical Devices including In-Vitro Diagnostics across the different Jurisdictions. The Pharmacy and Poisons board has participated in the capacity of observer to the IMDRF.
The Asian Harmonization working party (AHWP) provides a platform for regulators and industry experts to exchange and make proposals to member economies on best practices and regulatory convergence. The Pharmacy and Poisons board has actively participated and contributed to meetings and in the drafting of guidance documents.
International convergence as a way to accelerate access to medical Devices and In-Vitro Diagnostics
A rigorous regulatory framework is therefore required to safeguard public health through provision of health products that meet safety, effective and performance of Medical Devices including In-Vitro Diagnostics.
However, With an ever evolving landscape of cutting edge Medical technologies, International Convergence of regulatory procedures and harmonization efforts has provided platform for regulators to exchange scientific knowledge and international best practices enabling regulatory framework policy developments to be enhanced.
International Convergence of regulatory procedures has the results in removal of duplication of processes such as technical requirements, Human Capacity building and saving scarce resources for countries especially as is the case for many developing nations, like Kenya.
Regulatory convergence and increasing trust in regulatory decisions made by other competent authorities is one way to quicken access to quality essential medical devices and In-Vitro Diagnostics as it results in international and regional sharing of scientific resources and best practices resulting in more efficient resource use.
It is this reason that, through the Pharmacy and Poisons Board, Kenya successfully put forward her application towards becoming a member economy to the AHWP and endorsed as a member economy during the 22nd Asian Harmonization Working party annual meeting which was held in New Dehli, India.
Representatives from the Parliamentary Health Committee, Hon Dr David Simiyu Eseli, Mr Immanuel Muyodi clerk to the National Assembly, and the Pharmacy and Poisons Board, Dr Paulyne Wairimu and Dr Dominic Kariuki.
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