Clinical Evaluation of Immunotherapy Vaccines as Medical Devices: Regulatory Challenges and Assessment Strategies
Year: 2025
Type: article
Abstract: Medical approval of immunotherapy vaccines resulted in a transformative effect on disease treatment through immunesystem-based targeted therapy across oncology and infectious disease sector. The classification procedure for vaccinesproves to be a major obstacle under current medical device regulations. Under medical device regulations, the clinicalevaluation of immunotherapy vaccines demands complete knowledge of essential regulatory hurdles and assessmenttechniques. The various jurisdictions worldwide operationalize their specifications for vaccine approval, resulting invariable classification approaches, rigorous clinical trial protocols, and rigorous follow-up monitoring requirements.The main issues for immunotherapy vaccine evaluations consist of differing ways to classify them alongside theprocess for validation and the mandatory need to track their safety. Multiple steps are necessary to solve regulatoryissues in vaccine manufacturing that combine preclinical testing with adaptable clinical trial strategies andinternational regulatory consortium actions. Real-world evidence and advanced biotechnological innovations shouldbe used to improve assessment and approval processes. This study shows that an internationally standardizedregulatory framework must be established for immunotherapy vaccine compliance as medical devices to secure safety,efficacy, and public health innovation.
Authors: Chrysoula I. Liakou, Marios Papadakis, Markos Plytas
Institution: Witten/Herdecke University
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6930587306
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