1Faculty of Law, Marwadi University, Rajkot, Gujarat, India
2School of Law, SRM Institute of Science and Technology, Chennai, Tamil Nadu, India
*Author for Correspondence: parul.shukla@marwadieducation.edu.in
The rapid advancement of Advanced Drug Delivery Systems (ADDS) — including nanocarriers, targeted biologics, implantable devices, and controlled-release formulations — has significantly transformed the landscape of therapeutic precision in modern medicine. Nonetheless, these new technologies have provoked a set of complicated regulatory and legal issues especially in the need to balance patient safety and the imperatives of scientific research. In the present paper, the current legal and regulatory environment of clinical assessment of ADDS in the major jurisdictions in the United States, the European Union and India and global harmonization initiatives are critically considered. It reviews the sufficiency of preclinical toxicology studies, informed consent criteria, risk-benefit evaluation practices and post-market pharmacovigilance mechanisms. The paper has outlined the key regulatory loopholes, such as inadequate standard guidelines in nano-toxicology, and inter-jurisdictional definition gaps. It also suggests evidence based reforms a risk-proportional regulatory structure, a stronger toxicological monitoring system and international harmonization programs to develop a counterbalanced system that fosters innovation without violating patient rights or the duty to serve and protect the health of the populace.
Keywords: Advanced drug delivery systems, Clinical evaluation, Regulatory toxicology, Patient safety, Legal framework, Risk-benefit assessment, Pharmacovigilance.
How to cite this article: Parul S, Ishita C, Sudha PS. Balancing Innovation And Patient Safety: Legal Frameworks For Clinical Evaluation Of Advanced Drug Delivery Systems. Int J Drug Deliv Technol. 2026;16(7s): 803-809; DOI: 10.25258/ijddt.16.7s.85
Source of support: Nil
Conflict of interest: None