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Updated: Feb 27, 2026

Registered Bioimaging of Nanomaterials for Diagnostic and Therapeutic Monitoring
Published on: December 9, 2010
Updated Regulatory Considerations for Nanomedicines
T S Subin1, Venugopal Vijayan1, K Jaya R Kumar1
1Unit of Pharmaceutical Technology, Faculty of Pharmacy, Asian Institute of Medicine, Science and Technology (AIMST) University, Bedong 08100, Kedah. Malaysia.
Background:
Nanomedicine is a branch which deals with medicinal products, devices, nonbiological complex drugs and antibody-nanoparticle conjugates and general health products that are manufactured using nanotechnology.
Objective:
Nano-medicine provides the same efficacies as traditional medicines owing to their improved solubility and bioavailability with reduced dosages. However, there are currently safety concerns due to the difficulties related to nanomaterial characterization; this might be the reason for unawareness of such medicines among the patients. The absence of clear regulatory guidelines further complicates matters, as it makes the path to registering them with regulatory bodies difficult. However, some products have overcome these obstacles and have been registered. While there are many international initiatives to harmonize the regulatory requirements and helps the industry to determine the most important characteristics that influence in vivo product performance.
Conclusion:
This review focuses on the various types of nanopharmaceuticals, and developments process with strategies tailored to upcoming regulations may satisfy the patients' needs.
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