Introduction: Mortality in cancer has declined during recent years due to more efficient cancer treatments. Some of the novel immunotherapies against cancer under development has a risk of lacking regulatory guidance for the approval, such as neoantigen-based therapeutic vaccines. Aim: The purpose of the degree project is to evaluate the potential process of approval of neoantigen based vaccines from a regulatory perspective. Methods: The method used to gather data in the study is through qualitative interviews, regulatory documents, guidelines and data from current trials. Results: The results indicate that during the preclinical phase, neoantigen vaccines can receive warrants of a case-by-case approach leading to a more optimized development pathway. During clinical trials, the trial design could consist of master protocols, singlearm trials, comparative trials and adaptive trials where the control group may use the standard of care or historical controls. The indication in the trials should be cancer types with a high tumor mutational burden, low mortality rate, and high medical need. The biomarkers should evaluate immune and tumor response. Endpoints in early trials should evaluate safety and efficacy, and the tumor and immune response in pivotal trials. Neoantigen vaccines can use several incentives during the development and can be approved through conventional or conditional approval. Finally, the study suggests that it is yet too early for the agencies to have established any guidelines. However, advices from regulatory agencies can guide developers towards regulatory approval. Conclusion: This study shows that different study designs and various incentives can be used for the regulatory approval of individualized neoantigen based vaccines. Further guidelines need to be developed to enhance future development.