Due to the high burden of disease in sub-Saharan Africa (SSA) and growing pressure from international organisations, governments are multiplying efforts to control the quality of pharmaceutical products and medical devices available in the market.
“In an effort to reduce the prevalence of sub-standard products in the market, several drug regulatory authorities are drafting and implementing regulations for the control of medical devices,” notes Frost & Sullivan (pharmaceutical.frost.com) Analyst Tiwonge Mkandawire. “This is coupled with more stringent controls already in place for most pharmaceutical products.”
Medical devices in most SSA countries are typically treated as ‘normal commodities’ and are not being controlled by any kind of specific regulations required to protect patients and users. While a regulatory framework is in place for pharmaceutical products, implementing these standards brings its own set of challenges, such as a lack of specific scientific knowledge for drug regulation and insufficient financial resources.
Easily available counterfeit and inferior medical devices and pharmaceutical products in SSA countries pose a very real threat to internationally approved products of superior quality. Inadequate buying power of end users to purchase high-end products is another factor that allows the counterfeit and low-cost drug and medical device market to flourish.
“SSA countries need to develop effective legislation and control measures or modify existing regulations to ensure proper control,” says Mkandawire. “An improved regulatory environment is necessary to support the market potential that the SSA countries present.”
In Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) has already introduced strict restrictions on distribution channels in an attempt to curb the rampant availability of counterfeit drugs. The main focus is on encouraging the growth of the local manufacture and distribution of pharmaceutical products and medical devices.
The Kenyan and South African Governments are also framing regulations for the registration of medical devices that could well be implemented in the near future. There are currently no guidelines or systems in place for the registration and control of medical devices in either of these countries. In South Africa, products to be placed on the market generally have to be either FDA-approved or carry the CE mark, especially in the case of higher risk products.
Overall, most SSA countries are experiencing significant economic growth, suggesting that there is considerable market potential for pharmaceuticals and medical device companies to exploit.
However, companies will need to cultivate a thorough understanding of the regulatory landscape, its requirements and challenges to develop appropriate and effective strategies for market penetration. Additionally, developing sound relationships with local distributors and relevant regulatory bodies could help ensure the smooth placement of products on the market.
If you are interested in a virtual brochure, which provides manufacturers, end users and other industry participants with an overview of the latest analysis of the Regulatory Environment for Pharmaceutical Products and Medical Devices in Key sub-Saharan African Countries, then send an email to Patrick Cairns, Corporate Communications, at patrick.cairns[.]frost.com with your full name, company name, title, telephone number, fax number and email address. Upon receipt of the above information, an overview will be sent to you by email.
The Regulatory Environment for Pharmaceutical Products and Medical Devices in Key sub-Saharan African Countries is part of the Pharmaceutical Growth Partnership Service program, which also includes research on the following: Strategic Assessment of Healthcare and Medical Device Markets in Key Sub-Saharan African Countries, South African Implantable Cardiovascular Device Market, and Infectious Disease Diagnostics Markets in sub-Saharan Africa. All research services included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants. Interviews with the press are available.
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