EFDA’s new and sturdy regulatory strategy

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Ethiopia launches new regulatory preparedness and mitigation strategy as a result of past experience, the current COVID 19 threat and other emerging public health threats which affect the stability of the global medical products supply. Following these threats, the Ethiopian Food and Drug Authority (EFDA) has set up a regulatory strategy to help with the preparedness and mitigation strategies for emerging threats.
According to the authority, the strategy will help to protect and improve access to quality-assured medical products and protect the safety of patients and the public during health threats. Furthermore, it seeks to protect patients from falsified and substandard medical products.
The strategy aims to facilitate and accelerate priority research and innovations Including clinical trials, enhancement of Pharmacovigilance aspects, development of legal and guidance documents through working with the Ministry of Health to rapidly identify where flexibility in the regulation of medical products can prevent and respond to substandard and falsified medical products circulating in the market.
According to the authority during the pandemic situation, lack of medical products including medical supplies and personal protective equipment might have led to an increasing rate of infections and poor control of the pandemic. In addition illegal manufacturing, importation, and distribution of medical products are a challenge. Similarly, various actors have been taking the opportunity of gaps in product availability and repeated shortage to proliferate illegal practices that could endanger public safety. Public health emergencies might also exacerbate the ongoing problems of substandard and falsified medical products.
The regulation focuses on dealing with emerging health threats that could happen by biological, chemical, and other unknown elicit ways. It curbs this by ensuring sustained access to innovation, safe quality assured and effective medical products through mitigating medical products shortages during a public health emergency situation by building networks with academic research institutions and relevant stakeholders and partners.
Regular discussion held with local manufacturers and suppliers of medical products as well as interaction with Ethiopian Public Health Institute (EPHI) provides early warnings and response systems. Furthermore, regular interaction and information sharing with international organizations and regional organizations presents wider scope of understanding.
As stated on the regulatory strategy, at a time of health threats the authority should launch an Emergency steering committee, standing committee and an enforcement task force to mitigate the shortage of medical products and for containment of substandard and falsified medical products. The authority will intervene by setting up a system that enables the availability of medical products by considering a forecasted shortage and reviewing the risk of supply chain distribution for critically needed medical products.
The authority is mandated to lead regulatory services which contribute to the success of critical public health decisions made by the government. The Ethiopian public health institute is then responsible for the overall management and coordination of public health emergencies under the leadership of the Ministry of Health.