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Updated Regulatory Considerations for Nanomedicines

Author(s):

Sankarankutty Subin, Venugopal Vijayan and Jaya Raja Kumar*   Pages 1 - 12 ( 12 )

Abstract:


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.

Keywords:

Nanoparticle, regulatory, non-biological complex drugs, nanogeneric, nanomedicines, strategies.

Affiliation:

Unit of Pharmaceutical Technology, Faculty of Pharmacy, Asian Institute of Medicine, Science and Technology (AIMST) University, Bedong 08100, Kedah, Unit of Pharmaceutical Technology, Faculty of Pharmacy, Asian Institute of Medicine, Science and Technology (AIMST) University, Bedong 08100, Kedah, Unit of Pharmaceutical Technology, Faculty of Pharmacy, Asian Institute of Medicine, Science and Technology (AIMST) University, Bedong 08100, Kedah



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