Extracellular vesicles (EVs) are natural carriers that facilitate cell-to-cell communication across all kingdoms of life. They are involved in various physiological and pathological processes, including cancer development, infection, and cardiovascular diseases. EVs have several advantages over conventional synthetic carriers, making them promising for drug delivery. However, their clinical translation remains challenging due to their complexity and variability. This review discusses the unique properties of EVs, their potential as drug delivery systems, and the critical steps required for their development, including loading methods, characterization, and large-scale manufacturing. EVs are compared with established carriers like liposomes, and guidelines are provided for developing EV-based drug delivery systems. EVs are heterogeneous, consisting of various lipids and proteins, and their unique composition allows for targeted delivery. However, their complexity makes comprehensive characterization and quality control difficult. EVs can be derived from various sources, including mammalian, bacterial, and plant cells, and their properties depend on the parent cell. EVs have been shown to deliver therapeutic payloads to specific cells or tissues, and their natural tissue-homing capabilities make them attractive for drug delivery. However, their uptake by target cells is not fully understood, and their biological effects are still being studied. EVs have been used in regenerative medicine, such as in the treatment of wounds using mesenchymal stem cell-derived EVs. However, the use of EVs in clinical settings is still limited due to issues such as immunogenicity, safety, and the need for standardized production and characterization. The development of EV-based drug delivery systems requires careful consideration of their production, purification, and functionalization. EVs can be engineered to carry drugs, and their potential as next-generation therapeutics is being explored. Despite their promise, the clinical translation of EV-based therapies is hindered by challenges such as the need for large-scale production, the complexity of EVs, and the lack of standardized methods for their characterization. The use of EVs in clinical trials has been limited, and the safety and efficacy of EV-based therapies need to be thoroughly evaluated. The development of EV-based drug delivery systems requires further research to overcome these challenges and to ensure their safe and effective use in clinical settings.Extracellular vesicles (EVs) are natural carriers that facilitate cell-to-cell communication across all kingdoms of life. They are involved in various physiological and pathological processes, including cancer development, infection, and cardiovascular diseases. EVs have several advantages over conventional synthetic carriers, making them promising for drug delivery. However, their clinical translation remains challenging due to their complexity and variability. This review discusses the unique properties of EVs, their potential as drug delivery systems, and the critical steps required for their development, including loading methods, characterization, and large-scale manufacturing. EVs are compared with established carriers like liposomes, and guidelines are provided for developing EV-based drug delivery systems. EVs are heterogeneous, consisting of various lipids and proteins, and their unique composition allows for targeted delivery. However, their complexity makes comprehensive characterization and quality control difficult. EVs can be derived from various sources, including mammalian, bacterial, and plant cells, and their properties depend on the parent cell. EVs have been shown to deliver therapeutic payloads to specific cells or tissues, and their natural tissue-homing capabilities make them attractive for drug delivery. However, their uptake by target cells is not fully understood, and their biological effects are still being studied. EVs have been used in regenerative medicine, such as in the treatment of wounds using mesenchymal stem cell-derived EVs. However, the use of EVs in clinical settings is still limited due to issues such as immunogenicity, safety, and the need for standardized production and characterization. The development of EV-based drug delivery systems requires careful consideration of their production, purification, and functionalization. EVs can be engineered to carry drugs, and their potential as next-generation therapeutics is being explored. Despite their promise, the clinical translation of EV-based therapies is hindered by challenges such as the need for large-scale production, the complexity of EVs, and the lack of standardized methods for their characterization. The use of EVs in clinical trials has been limited, and the safety and efficacy of EV-based therapies need to be thoroughly evaluated. The development of EV-based drug delivery systems requires further research to overcome these challenges and to ensure their safe and effective use in clinical settings.