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Safety assessment of natural products in Malaysia: current practices, challenges, and new strategies

  • Nur Azra M. Pauzi EMAIL logo , Manraj S. Cheema , Amin Ismail , Ahmad Rohi Ghazali and Rozaini Abdullah ORCID logo
Published/Copyright: September 27, 2021

Abstract

The belief that natural products are inherently safe is a primary reason for consumers to choose traditional medicines and herbal supplements for health maintenance and disease prevention. Unfortunately, some natural products on the market have been found to contain toxic compounds, such as heavy metals and microbes, as well as banned ingredients such as aristolochic acids. It shows that the existing regulatory system is inadequate and highlights the importance of thorough safety evaluations. In Malaysia, the National Pharmaceutical Regulatory Agency is responsible for the regulatory control of medicinal products and cosmetics, including natural products. For registration purpose, the safety of natural products is primarily determined through the review of documents, including monographs, research articles and scientific reports. One of the main factors hampering safety evaluations of natural products is the lack of toxicological data from animal studies. However, international regulatory agencies such as the European Food Safety Authority and the United States Food and Drug Administration are beginning to accept data obtained using alternative strategies such as non-animal predictive toxicological tools. Our paper discusses the use of state-of-the-art techniques, including chemometrics, in silico modelling and omics technologies and their applications to the safety assessments of natural products.


Corresponding author: Nur Azra M. Pauzi, Department of Environmental and Occupational Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Selangor, Malaysia; and Ministry of Health, Kompleks E, Pusat Pentadbiran Kerajaan Persekutuan, Putrajaya, Malaysia, Fax: + 603 9769 2585, E-mail:

Funding source: Ministry of Higher Education, Malaysia

Award Identifier / Grant number: FRGS/1/2018/SKK06/UPM/02/10)

Funding source: Ministry of Health of Malaysia

Award Identifier / Grant number: KKM.500-7/33/2019/830807105608(5)

  1. Research funding: This research was supported by the Ministry of Higher Education under the Fundamental Research Grant Scheme (Project number: FRGS/1/2018/SKK06/UPM/02/10), and Ministry of Health of Malaysia (Ref num: KKM.500-7/33/2019/830807105608(5)).

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Not applicable.

  5. Ethical approval: Not applicable.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/reveh-2021-0072).


Received: 2021-05-24
Accepted: 2021-09-06
Published Online: 2021-09-27
Published in Print: 2022-06-27

© 2021 Walter de Gruyter GmbH, Berlin/Boston

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