OBJECTIVES: This paper aims to discuss the consequences of the broadened use of the "adaptive pathways" in the EU countries, the availability of adequate measures in the current regulatory framework and healthcare system to ensure public health benefit and reduce hazards. Finally, this paper will draw policy recommendations on how to manage the entrance of these kind of products to the Egyptian Market.  METHODS: Literature review is done to set a list of measurements and prerequisites in the regulatory and healthcare system to ensure and monitor the benefit-risk balance across the product life cycle. A focus group of medicines regulators and healthcare system experts was established to discuss the existence of these measurements within the Egyptian regulatory framework and healthcare system context. Finally a list of policy recommendations will be set for the safe introduction of medicines approved by "adaptive pathway" to the Egyptian market.   RESULTS: Health system decision makers and the Egyptian Drug Authority should ensure that the following measurements will be in place before starting the introduction of "Adaptive licensing" medicines: Vigilance regulation is fulfilled; Regulatory bodies closely monitor the promotion practice and prescribing practice to prevent off-label use; The Egyptian Drug Authority should revisit the definition of unmet medical need; Payers and health insurance organization should reconsider their reimbursement mechanisms and shift to payment-for- performance scheme; The MOH should ensure the availability of unbiased clear information for patients; Patient Registry systems in MOH and University tertiary hospitals should be strengthened and there should be a mechanism in place to compensate patients for any resulted harms from the therapy. CONCLUSIONS: Medicines approved by "adaptive pathway" should get a market authorization in Egypt only if there is an unmet medical need.