In Practice

Complementary medicines: When regulation results in revolution

Liezl Fourie, Frasia Oosthuizen, Karen du Toit

Abstract


Medicines have evolved over time and so has the realisation of the importance of quality control and regulatory processes. The regulatory practices include all the steps from the development and manufacture of the active ingredients until the medicines reach the consumer. The Medicines Control Council (MCC) is mandated to regulate medicines in South Africa. Complementary medicines were previously perceived to be unregulated, although the Medicines Act does not distinguish between allopathic and complementary medicine. As the era of unregulated complementary medicine ended, the requirements in terms of dossier content left many role-players at odds. However, the MCC has a mandate to ensure that the registration of a medicine is in the interest of the public and that complementary medicine is manufactured in a facility adhering to good manufacturing practice, according to which efficacy and safety are supported by reliable data with a known shelf-life.


Authors' affiliations

Liezl Fourie, Discipline of Pharmaceutical Sciences, Faculty of Health Sciences, University of KwaZulu-Natal, Durban, South Africa

Frasia Oosthuizen, Discipline of Pharmaceutical Sciences, Faculty of Health Sciences, University of KwaZulu-Natal, Durban, South Africa

Karen du Toit, Discipline of Pharmaceutical Sciences, Faculty of Health Sciences, University of KwaZulu-Natal, Durban, South Africa

Full Text

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Keywords

Medicines Act; Regulations; Complementary medicines; South Africa; Medicines Control Council

Cite this article

South African Medical Journal 2017;107(6):483-485. DOI:10.7196/SAMJ.2017.v107i6.12055

Article History

Date submitted: 2017-05-24
Date published: 2017-05-24

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