ArticleJournal of pharmaceutical policy and practice2025
The issues and challenges of addressing the importation of unregistered pharmaceutical products in Malaysia.
Article in Journal of pharmaceutical policy and practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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2 authors.
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Abstract
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.
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