The article provides an overview of the Kenyan regulatory requirements in the sphere of post-market surveillance for healthcare products.
Table of Contents
The Pharmacy and Poison Board, a division of the Kenyan Ministry of Health, has published the guidelines for post-marketing surveillance of medical products and health technologies in Kenya. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by the parties responsible for medical devices to ensure compliance with the said requirements. At the same time, provisions of the guidelines are non-binding, and could be subject to changes, should it be reasonably necessary to reflect the respective amendments to the underlying legislation.
Terms and Definitions
First of all, the document provides the definitions of the most important terms and concepts used in the context of post-market surveillance including, inter alia, the following ones:
- Convenient sampling (availability sampling) – is a specific type of non-probability sampling method that relies on data collection from a population that is conveniently available to participate in the study.
- Field screening techniques – the qualitative and/or semi-quantitative tests that could rapidly acquire preliminary analytical information or data on the quality of medical products in the field.
- Post-marketing quality survey – a systematic, structured study that is carried out to determine the quality of medical products and health technologies available to patients at a point in time. The quality survey relies on laboratory testing to check on compliance of products with standards and/or specifications.
- Quality assurance – an integrated system of activities involving planning, quality control, quality assessment, reporting, and quality improvement to ensure that a product or service meets defined standards of quality with a stated level of confidence.
- Rapid alert system – a system designed to ensure a timely, proportionate, accurate, and consistent response to health events arising from sub-standard and falsified medical products which represent a significant threat to the health and safety of the public.
Apart from the ones described hereinabove, the document also provides the definitions of such terms as “corrective and preventive actions”, “falsified [medical product]”, “health technology”, “health providers/professionals”, “IVD”, “manufacturer”, “marketing authorization holder”, “medical product”, “pharmaceutical outlet”, “poor quality medical product”, “post-marketing surveillance”, “quality defects”, “random sampling”, “regulatory actions”, “sample”, “sample size”, “sampling plan”, “special inspections”, “stratified sampling”, “substandard”, and “targeted sampling”. The aforementioned definitions should be used only in the meaning described in the present guidance to ensure the correct interpretation of the applicable legislation.
Regulatory Background
According to the guidance, an efficient regulatory framework has been developed and implemented to ensure the quality, safety, and effectiveness of medical devices and other healthcare products intended to be marketed and used in the country. At the same time, the authority additionally emphasizes the importance of the efficient cooperation of all the parties involved in operations with healthcare products in ensuring the proper quality of the latter. For instance, the authority mentions that sometimes the safety and quality of healthcare products could be affected during the shelf life when these products are stored after being released by the manufacturer due to inappropriate business practices used by the parties participating in the supply chain. Apart from this, the properties of healthcare products could be affected by climatic conditions and other external factors, so it is important to ensure the impact of these factors is duly mitigated. Hence, efficient post-marketing surveillance measures should be implemented to ensure the continuous safety and quality of healthcare products. According to the guidance, Post Market Surveillance (PMS) is the practice of monitoring the quality, safety, and efficacy of medical products and health technologies circulating in the market after registration. The authority further explains that post-market surveillance is an important tool in monitoring the quality of medical products and health technologies after authorization because it assures the quality of medical products and prevents harm to patients.
As described in the document, post-marketing surveillance guidelines are intended to:
- Provide recommendations to be followed when undertaking continuous monitoring of the quality, safety, and effectiveness of healthcare products marketed in the country;
- Assist in developing and implementing the efficient methods allowing for identifying safety- and quality-related issues;
- Ensure the good distribution and storage practices are duly followed by all the parties involved in the supply of healthcare products;
- Ensure that all the market participants have valid authorization to undertake the appropriate activities;
- Promote understanding, education, and training in PMS programs and activities and their effective communication to the public.
Applicable Legislation
The general principle of safety and quality of healthcare products allowed for marketing and use in Kenya is set forth by the country’s constitution. Apart from this, the Pharmacy and Poison Act authorizes the regulatory agency to conduct the activities in the sphere of post-marketing surveillance to ensure continuous quality, safety, and effectiveness of healthcare products that are available for healthcare professionals and patients.
National PMS System
The document further describes the national post-marketing surveillance system and provides additional information about its key elements and functions. According to the guidance, the country’s PMS system comprises:
- The National reporting system;
- The National Pharmacovigilance and Post-Marketing Surveillance Technical Working Group (PV/PMS TWG);
- The Quality Control testing laboratories.
The activities are performed by the device of both manual and electronic means, including the Pharmacovigilance Electronic Reporting System (PvERS).
Apart from the above-mentioned key elements, the national PMS system also includes all the parties involved in operations with healthcare products, such as medical device manufacturers, healthcare providers, authorized laboratories, and marketing authorization holders. The authority additionally emphasizes that the country’s PMS system includes all the layers of the healthcare facilities and covers all types of healthcare products placed on the market.
The PMS system is subject to continuous development and improvement to ensure the effectiveness of the methods it adopts. For this purpose, the PMS system works closely with other government departments and programs, various organizations, and institutions, to develop an effective feedback mechanism that serves to protect the health and safety of the public.
In summary, the present guidance outlines the basics of the Kenyan post-marketing surveillance system, including its key elements and main principles. The document also describes in detail the approach to be applied to ensure the continuous quality, safety, and effectiveness of healthcare products allowed to be marketed and used in the country.
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