Summarizes the key aspects related to regulatory considerations in the field of nanomedicine
Regulatory aspect
Description
Molecular safety assessment
Evaluation of the potential interactions between nanoparticles and biomolecules at the molecular level.
Assessment of potential cytotoxicity, immunogenicity, and unintended molecular effects [37].
Characterization of nanoparticle behavior in biological environments to ensure molecular compatibility.
Harmonizing regulatory landscape
Developing international standards for the evaluation and approval of nanomedicine products.
Establishing consistent guidelines for molecular safety assessment, efficacy evaluation, and quality control.
Collaboration between regulatory agencies to streamline approval processes for cross-border nanomedicine products.
Shaping future nanomedicine innovations
Incorporating molecular safety assessments into the early stages of nanomedicine development.
Encouraging industry collaboration to share molecular safety data and foster responsible innovation.
Designing regulatory frameworks that adapt to the rapidly evolving nature of nanomedicine innovations.
Regulatory challenges
Lack of standardized methods for evaluating molecular interactions and safety at the nanoscale.
Balancing the need for patient access to innovative nanomedicine products with robust safety assessments.
Addressing the unique challenges posed by multifunctional nanoparticles and novel molecular designs.
Ensuring that regulatory agencies have the expertise and capacity to evaluate nanomedicine products effectively.
Declarations
Author Contributions
AVS, PB, and AKU equally contributed to: Conceptualization, Investigation, Writing—original draft, Writing—review & editing. AP, JU, and JB: Conceptualization, Investigation, Writing—original draft, Writing—review & editing. VT, DG, and MT: Validation, Writing—review & editing, Supervision. RM and PZ: Supervision, Project administration. All authors read and approved the submitted version.
Conflicts of interest
The authors declare that they have no conflicts of interest.
Ethical approval
Not applicable.
Consent to participate
Not applicable.
Consent to publication
Not applicable.
Availability of data and materials
The data supporting the findings of this study are available upon request.
Funding
This study was funded by the application of multivalent biomineralized nanostructures as a modular strategy for targeting colorectal cancer [CDIRCC-2024-468] by Qatar University. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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