Situation analysis on the regulation of nanomedicines in Southern Africa
BackgroundMedical products incorporating nanoparticle drug delivery systems (nanomedicines) are therapeutic or imaging agents, which comprise a delivery system within the nanometer size range (1 – 1000 nm). As medical products, nanomedicines meet definitions of medicines according to various nationa...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-04-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2023.1098830/full |
| _version_ | 1797843601364877312 |
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| author | Linda G. Mudyiwenyama Star Khoza Admire Dube |
| author_facet | Linda G. Mudyiwenyama Star Khoza Admire Dube |
| author_sort | Linda G. Mudyiwenyama |
| collection | DOAJ |
| description | BackgroundMedical products incorporating nanoparticle drug delivery systems (nanomedicines) are therapeutic or imaging agents, which comprise a delivery system within the nanometer size range (1 – 1000 nm). As medical products, nanomedicines meet definitions of medicines according to various national legislations for regulation of medicines. However, for the regulation of nanomedicines, additional assessments including toxicological issues have to be considered. These complexities require extra regulatory effort. In the resource-limited context of low- and middle-income countries, many National Medicines Regulatory Authorities (NMRAs) lack resources and capacities to effectively assure the quality of medicinal products in their countries. With emerging trends in innovative technologies, including nanotechnology, this burden is worsened. The need to overcome regulatory challenges drove the formation of a work sharing initiative in the Southern African Development Community (SADC), ZaZiBoNA in 2013. Regulatory agencies participating in this initiative cooperate in the assessment of applications for registration of medicines.MethodsA cross-sectional exploratory study design with qualitative techniques was used to investigate the status of the regulation of nanomedicines in Southern African countries in particular those participating in the ZaZiBoNA initiative.ResultsThe study found that in general, NMRAs are aware of the existence of nanomedicines and they apply legislation applicable to other medical products. The NMRAs however neither have specific definition for nanomedicines and technical guidance documents, nor technical committees specific for consideration of nanomedicines. Collaboration with external experts or organisations in the regulation of nanomedicines was also found to be lacking.DiscussionCapacity building and collaboration in the area of regulation of nanomedicines is strongly encouraged. |
| first_indexed | 2024-04-09T17:07:59Z |
| format | Article |
| id | doaj.art-cb187eceb5fb4114b29f699222b8a41e |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-04-09T17:07:59Z |
| publishDate | 2023-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-cb187eceb5fb4114b29f699222b8a41e2023-04-20T09:32:07ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2023-04-011010.3389/fmed.2023.10988301098830Situation analysis on the regulation of nanomedicines in Southern AfricaLinda G. MudyiwenyamaStar KhozaAdmire DubeBackgroundMedical products incorporating nanoparticle drug delivery systems (nanomedicines) are therapeutic or imaging agents, which comprise a delivery system within the nanometer size range (1 – 1000 nm). As medical products, nanomedicines meet definitions of medicines according to various national legislations for regulation of medicines. However, for the regulation of nanomedicines, additional assessments including toxicological issues have to be considered. These complexities require extra regulatory effort. In the resource-limited context of low- and middle-income countries, many National Medicines Regulatory Authorities (NMRAs) lack resources and capacities to effectively assure the quality of medicinal products in their countries. With emerging trends in innovative technologies, including nanotechnology, this burden is worsened. The need to overcome regulatory challenges drove the formation of a work sharing initiative in the Southern African Development Community (SADC), ZaZiBoNA in 2013. Regulatory agencies participating in this initiative cooperate in the assessment of applications for registration of medicines.MethodsA cross-sectional exploratory study design with qualitative techniques was used to investigate the status of the regulation of nanomedicines in Southern African countries in particular those participating in the ZaZiBoNA initiative.ResultsThe study found that in general, NMRAs are aware of the existence of nanomedicines and they apply legislation applicable to other medical products. The NMRAs however neither have specific definition for nanomedicines and technical guidance documents, nor technical committees specific for consideration of nanomedicines. Collaboration with external experts or organisations in the regulation of nanomedicines was also found to be lacking.DiscussionCapacity building and collaboration in the area of regulation of nanomedicines is strongly encouraged.https://www.frontiersin.org/articles/10.3389/fmed.2023.1098830/fullregulation of nanomedicinesAfrican Medicines Agencyregulatory workforce capacity buildingnanomedicineZaZiBoNAmedical products regulation |
| spellingShingle | Linda G. Mudyiwenyama Star Khoza Admire Dube Situation analysis on the regulation of nanomedicines in Southern Africa Frontiers in Medicine regulation of nanomedicines African Medicines Agency regulatory workforce capacity building nanomedicine ZaZiBoNA medical products regulation |
| title | Situation analysis on the regulation of nanomedicines in Southern Africa |
| title_full | Situation analysis on the regulation of nanomedicines in Southern Africa |
| title_fullStr | Situation analysis on the regulation of nanomedicines in Southern Africa |
| title_full_unstemmed | Situation analysis on the regulation of nanomedicines in Southern Africa |
| title_short | Situation analysis on the regulation of nanomedicines in Southern Africa |
| title_sort | situation analysis on the regulation of nanomedicines in southern africa |
| topic | regulation of nanomedicines African Medicines Agency regulatory workforce capacity building nanomedicine ZaZiBoNA medical products regulation |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2023.1098830/full |
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