Abstract
The translation of nanomedicines from the lab level into marketed product faces several challenges, including characterization of physicochemical properties, pharmacodynamics, pharmacokinetics, process control, biocompatibility, and nanotoxicity, scaling-up as well as reproducibility. The challenges of nanomedicine development are in connection with the different requirements from the patient (clinical and therapeutic use), industry (production), and regulatory bodies (authorization process). This paper aims at reviewing the status and regulatory aspects of nano-based drug delivery systems with a focus on the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) regulations. In addition to discussing the risks accompanied by the development of nanomedicine, the potential of following a risk-based methodology from the early stage of the R&D phase is emphasized here to ensure safety and efficacy when developing novel nano-based dosage forms. The R&D of nanomedicines is a complex and multidisciplinary approach, and there are still many challenges in their regulation and legislation. In general, the most critical considerations for nanomedicines are the product quality assessment (physicochemical characteristics, quality control, manufacturing process) and product safety assessment (pharmacokinetics, biodegradation, accumulation, and nanotoxicity). The paper presents a promising paradigm in the development and marketing authorization of nanomedicines, namely the Quality by Design (QbD) approach. Sufficient knowledge on the quality, safety, and efficacy of nanomedicines is necessary to obtain a significant focus on establishing robust, standardized methods for evaluating the critical quality attributes of nanomedicines. The QbD-based submission is highly recommended and required by the regulatory authorities, enabling a smooth clinical translation of the novel nanomedicines.
Keywords: European Medicine Agency (EMA), Food and Drug Administration (FDA), Nanomedicine, Nanotoxicity, Quality by Design (QbD), Risk Assessment (RA), Drug development.
Current Medicinal Chemistry
Title:Regulatory Considerations, Challenges and Risk-based Approach in Nanomedicine Development
Volume: 28 Issue: 36
Author(s): Ildikó Csóka, Ruba Ismail*, Orsolya Jójárt-Laczkovich and Edina Pallagi
Affiliation:
- Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, Eötvös str. 6, H-6720 Szeged,Hungary
Keywords: European Medicine Agency (EMA), Food and Drug Administration (FDA), Nanomedicine, Nanotoxicity, Quality by Design (QbD), Risk Assessment (RA), Drug development.
Abstract: The translation of nanomedicines from the lab level into marketed product faces several challenges, including characterization of physicochemical properties, pharmacodynamics, pharmacokinetics, process control, biocompatibility, and nanotoxicity, scaling-up as well as reproducibility. The challenges of nanomedicine development are in connection with the different requirements from the patient (clinical and therapeutic use), industry (production), and regulatory bodies (authorization process). This paper aims at reviewing the status and regulatory aspects of nano-based drug delivery systems with a focus on the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) regulations. In addition to discussing the risks accompanied by the development of nanomedicine, the potential of following a risk-based methodology from the early stage of the R&D phase is emphasized here to ensure safety and efficacy when developing novel nano-based dosage forms. The R&D of nanomedicines is a complex and multidisciplinary approach, and there are still many challenges in their regulation and legislation. In general, the most critical considerations for nanomedicines are the product quality assessment (physicochemical characteristics, quality control, manufacturing process) and product safety assessment (pharmacokinetics, biodegradation, accumulation, and nanotoxicity). The paper presents a promising paradigm in the development and marketing authorization of nanomedicines, namely the Quality by Design (QbD) approach. Sufficient knowledge on the quality, safety, and efficacy of nanomedicines is necessary to obtain a significant focus on establishing robust, standardized methods for evaluating the critical quality attributes of nanomedicines. The QbD-based submission is highly recommended and required by the regulatory authorities, enabling a smooth clinical translation of the novel nanomedicines.
Export Options
About this article
Cite this article as:
Csóka Ildikó, Ismail Ruba *, Jójárt-Laczkovich Orsolya and Pallagi Edina , Regulatory Considerations, Challenges and Risk-based Approach in Nanomedicine Development, Current Medicinal Chemistry 2021; 28 (36) . https://dx.doi.org/10.2174/0929867328666210406115529
DOI https://dx.doi.org/10.2174/0929867328666210406115529 |
Print ISSN 0929-8673 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-533X |
Call for Papers in Thematic Issues
Advances in Medicinal Chemistry: From Cancer to Chronic Diseases.
The broad spectrum of the issue will provide a comprehensive overview of emerging trends, novel therapeutic interventions, and translational insights that impact modern medicine. The primary focus will be diseases of global concern, including cancer, chronic pain, metabolic disorders, and autoimmune conditions, providing a broad overview of the advancements in ...read more
Cellular and Molecular Mechanisms of Non-Infectious Inflammatory Diseases: Focus on Clinical Implications
The Special Issue covers the results of the studies on cellular and molecular mechanisms of non-infectious inflammatory diseases, in particular, autoimmune rheumatic diseases, atherosclerotic cardiovascular disease and other age-related disorders such as type II diabetes, cancer, neurodegenerative disorders, etc. Review and research articles as well as methodology papers that summarize ...read more
Chalcogen-modified nucleic acid analogues
Chalcogen-modified nucleosides, nucleotides and oligonucleotides have been of great interest to scientific research for many years. The replacement of oxygen in the nucleobase, sugar or phosphate backbone by chalcogen atoms (sulfur, selenium, tellurium) gives these biomolecules unique properties resulting from their altered physical and chemical properties. The continuing interest in ...read more
Current advances in inherited cardiomyopathy
Describe in detail all novel advances in multimodality imaging related to inherited cardiomyopathy diagnosis and prognosis. Shed light to deeper phenotypic characterization. Acknowledge recent advances in genetics, genomics and precision medicineread more
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
- Announcements
Related Articles
-
Luminescent Quantum Dots: A Very Attractive and Promising Tool in Biomedicine
Current Medicinal Chemistry Selective Targeted Drug Delivery Mechanism via Molecular Imprinted Polymers in Cancer Therapeutics
Current Topics in Medicinal Chemistry Pharmacogenetics in Laboratory Diagnostics
Current Pharmacogenomics and Personalized Medicine Quantitative Structure-Activity Relationships for Commercially Available Inhibitors of COX-2
Medicinal Chemistry α,β-Acetylenic Amino Thiolester Inhibitors of Aldehyde Dehydrogenases 1&3: Suppressors of Apoptogenic Aldehyde Oxidation and Activators of Apoptosis
Current Medicinal Chemistry Stimuli-responsive Drug Delivery Nanosystems: From Bench to Clinic
Current Nanomedicine Mining PeptideAtlas for Biomarkers and Therapeutics in Human Disease
Current Pharmaceutical Design Potential Health Hazards for Cumulative Exposures to Phthalates and Ionizing Radiation in High-Risk Pediatric Population
Mini-Reviews in Medicinal Chemistry Glycomics: Towards Bioinformatic Approaches to Understanding Glycosylation
Anti-Cancer Agents in Medicinal Chemistry Momordica balsamina: A Medicinal and Neutraceutical Plant for Health Care Management
Current Pharmaceutical Biotechnology Glycan-Binding Profile and Cell Adhesion Activity of American Bullfrog (Rana catesbeiana) Oocyte Galectin-1
Protein & Peptide Letters Biomedical Applications of Natural Polymers for Drug Delivery
Current Organic Chemistry Energetics of Quadruplex-Drug Recognition in Anticancer Therapy
Current Cancer Drug Targets Release Kinetics of Hydroxypropyl Methylcellulose Governing Drug Release and Hydrodynamic Changes of Matrix Tablet
Current Drug Delivery Cellular Toxicity and Apoptosis Studies in Osteocarcinoma Cells, a Comparison of 177Lu-EDTMP and Lu-EDTMP
Current Radiopharmaceuticals Microsome Biocolloids for Rapid Drug Metabolism and in hibition Assessment by LC-MS
Drug Metabolism Letters Liposomes Prepared in Absence of Organic Solvents: Sonication Versus Lipid Film Hydration Method
Current Pharmaceutical Analysis Resveratrol as an Enhancer of Apoptosis in Cancer: A Mechanistic Review
Anti-Cancer Agents in Medicinal Chemistry Activatable Optical Probes for the Detection of Enzymes
Current Organic Synthesis Recent Aspects of Osmotic Pump Systems: Functionalization, Clinical use and Advanced Imaging Technology
Current Drug Metabolism