Comparative study of the registration procedure of locally manufactured herbal products in selected African countries

The registration of LMHMs is simplified in selected African countries. However, despite this flexibility, few LMHM products get registered and obtain market authorization. Drug regulatory authorities in Africa must address the challenges that hinder the registration of herbal products and take action to promote the local production of herbal medicines while complying with the fundamental registration criteria for product safety, efficiency, and quality control.

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Publication Details

Journal
Frontiers in Pharmacology
Published
2025-12-05
DOI
https://doi.org/10.3389/fphar.2025.1695809
Primary Topic
Pharmaceutical Quality and Counterfeiting
Type
article
Field-Weighted Citation Impact
0.00

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article

Comparative study of the registration procedure of locally manufactured herbal products in selected African countries

Nceba Gqaleni, Lehlohonolo J. Mathibe, Limakatso Lebina, Aisha Gambo
Frontiers in Pharmacology
Pharmaceutical Quality and Counterfeiting
article

Comparative study of the registration procedure of locally manufactured herbal products in selected African countries

Nceba Gqaleni, Lehlohonolo J. Mathibe, Limakatso Lebina, Aisha Gambo
article en

Abstract

The registration of LMHMs is simplified in selected African countries. However, despite this flexibility, few LMHM products get registered and obtain market authorization. Drug regulatory authorities in Africa must address the challenges that hinder the registration of herbal products and take action to promote the local production of herbal medicines while complying with the fundamental registration criteria for product safety, efficiency, and quality control.

Frontiers in PharmacologyVol. 16
Africa Health Research Institute (ZA), University of KwaZulu-Natal (ZA)
Inyuvesi Yakwazulu-Natali
Openalex Percentile: Top 51%
Pharmaceutical Quality and Counterfeiting
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