EDA Guidance on Clinical Trials: Overview
The article highlights the key points related to the regulatory framework for clinical trials in Egypt.
The article highlights the key points related to the regulatory framework for clinical trials in Egypt.
The article describes in detail the matters related to the objectives of clinical trials, as well as the applicable regulatory oversight.
The new article outlines the key points to be addressed when initiating a clinical investigation, as well as upon its completion.
The new article provides additional clarifications regarding various specific aspects to be taken into consideration by the parties responsible for clinical investigations intended to be conducted in Egypt.
The new article provides additional clarifications regarding specific aspects associated with recalls, such as appeals to relevant decisions or disposal for medical products.
The new article pays special attention to the classification of recall actions taken in order to ensure the continuous safety of medical devices allowed for marketing and use in the country.
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