The issues and challenges of addressing the importation of unregistered pharmaceutical products in Malaysia
Background: Unregistered pharmaceutical products, which have not undergone evaluation by the national regulatory agency, pose significant risks to public health. The continuous influx of these unregistered products into Malaysia highlights the inadequacies within the current regulatory approach. Exi...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2025-12-01
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| Series: | Journal of Pharmaceutical Policy and Practice |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/20523211.2025.2523939 |
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| author | Lay Peng Lim Mohammad Firdaus Bin Abdul Aziz |
| author_facet | Lay Peng Lim Mohammad Firdaus Bin Abdul Aziz |
| author_sort | Lay Peng Lim |
| collection | DOAJ |
| description | Background: Unregistered pharmaceutical products, which have not undergone evaluation by the national regulatory agency, pose significant risks to public health. The continuous influx of these unregistered products into Malaysia highlights the inadequacies within the current regulatory approach. Existing literatures show that there is a gap in knowledge regarding the challenges encountered by enforcement agencies during inspection of imported pharmaceutical products at entry points. Therefore, this study aims to identify the issues and challenges encountered by enforcement officers in curbing the importation of unregistered products and propose recommendations that can be considered to enhance legal enforcement.Methods: This study employed a qualitative approach by conducting one-to-one interviews with twelve Pharmacy Enforcement Officers and Customs Officers to gather relevant insights.Results: The key issues and challenges encountered in controlling the importation of unregistered products were categorised into several themes, including (i) organisational constraints; (ii) technical challenges; (iii) modus operandi employed by importer; and (iv) external challenges, such as proliferation of online platforms and persistent market demand for unregistered products.Conclusion: The findings revealed that the issues and challenges faced by enforcement officers stem from the inadequacies identified in the existing laws and regulatory practices. Multifaceted approaches that encompass legislative reforms, administrative transformation and rigorous enforcement are necessary in fostering more effective control over the importation of unregistered products in Malaysia. |
| format | Article |
| id | doaj-art-656ee23ebae04731884e944b4fe1f5b4 |
| institution | Kabale University |
| issn | 2052-3211 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Pharmaceutical Policy and Practice |
| spelling | doaj-art-656ee23ebae04731884e944b4fe1f5b42025-08-20T03:33:41ZengTaylor & Francis GroupJournal of Pharmaceutical Policy and Practice2052-32112025-12-0118110.1080/20523211.2025.2523939The issues and challenges of addressing the importation of unregistered pharmaceutical products in MalaysiaLay Peng Lim0Mohammad Firdaus Bin Abdul Aziz1Faculty of Law, Universiti Malaya, Kuala Lumpur, MalaysiaFaculty of Law, Universiti Malaya, Kuala Lumpur, MalaysiaBackground: Unregistered pharmaceutical products, which have not undergone evaluation by the national regulatory agency, pose significant risks to public health. The continuous influx of these unregistered products into Malaysia highlights the inadequacies within the current regulatory approach. Existing literatures show that there is a gap in knowledge regarding the challenges encountered by enforcement agencies during inspection of imported pharmaceutical products at entry points. Therefore, this study aims to identify the issues and challenges encountered by enforcement officers in curbing the importation of unregistered products and propose recommendations that can be considered to enhance legal enforcement.Methods: This study employed a qualitative approach by conducting one-to-one interviews with twelve Pharmacy Enforcement Officers and Customs Officers to gather relevant insights.Results: The key issues and challenges encountered in controlling the importation of unregistered products were categorised into several themes, including (i) organisational constraints; (ii) technical challenges; (iii) modus operandi employed by importer; and (iv) external challenges, such as proliferation of online platforms and persistent market demand for unregistered products.Conclusion: The findings revealed that the issues and challenges faced by enforcement officers stem from the inadequacies identified in the existing laws and regulatory practices. Multifaceted approaches that encompass legislative reforms, administrative transformation and rigorous enforcement are necessary in fostering more effective control over the importation of unregistered products in Malaysia.https://www.tandfonline.com/doi/10.1080/20523211.2025.2523939Importunregistered productsmedicinespharmaceutical productspharmacy enforcement |
| spellingShingle | Lay Peng Lim Mohammad Firdaus Bin Abdul Aziz The issues and challenges of addressing the importation of unregistered pharmaceutical products in Malaysia Journal of Pharmaceutical Policy and Practice Import unregistered products medicines pharmaceutical products pharmacy enforcement |
| title | The issues and challenges of addressing the importation of unregistered pharmaceutical products in Malaysia |
| title_full | The issues and challenges of addressing the importation of unregistered pharmaceutical products in Malaysia |
| title_fullStr | The issues and challenges of addressing the importation of unregistered pharmaceutical products in Malaysia |
| title_full_unstemmed | The issues and challenges of addressing the importation of unregistered pharmaceutical products in Malaysia |
| title_short | The issues and challenges of addressing the importation of unregistered pharmaceutical products in Malaysia |
| title_sort | issues and challenges of addressing the importation of unregistered pharmaceutical products in malaysia |
| topic | Import unregistered products medicines pharmaceutical products pharmacy enforcement |
| url | https://www.tandfonline.com/doi/10.1080/20523211.2025.2523939 |
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