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Related Concept Videos

Drug Regulation01:25

Drug Regulation

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Combined Effects of Drugs: Synergism01:27

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Synergism is a useful mechanism where combining two or more drugs is more effective than each constituent used alone. Such combinations are also called supra-additive interactions. The drugs collectively enhance the final therapeutic effect by acting on different targets. Another advantage is that the low dose of each constituent drug is sufficient to achieve the desired effect. This helps reduce the duration of therapy and lower the adverse effects of these drugs.
Such synergistic combinations...
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Effects of Chemicals: Overview01:27

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Drugs, encompassing various chemical compounds from natural sources, lab synthesis, or genetic engineering, elicit different biological responses in living organisms. Some of these responses are desirable or therapeutic, while others are undesirable. The primary goal of administering a drug is to achieve a therapeutic effect, that is, to address a specific disease or health condition. Any concurrent effects outside of this therapeutic outcome are considered undesirable. These undesirable...
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Drug Control Governance: Regulatory Bodies and Their Impact01:03

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Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
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Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

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Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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Related Experiment Video

Updated: Feb 28, 2026

Preparation of Herbal Medicine: Er-Xian Decoction and Er-Xian-containing Serum for In Vivo and In Vitro Experiments
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Preparation of Herbal Medicine: Er-Xian Decoction and Er-Xian-containing Serum for In Vivo and In Vitro Experiments

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Complementary medicines: When regulation results in revolution.

Liezl Fourie1, Frasia Oosthuizen, Karen Du Toit

  • 1Discipline of Pharmaceutical Sciences, Faculty of Health Sciences, University of KwaZulu-Natal, Durban, South Africa. liezl.fourie14@gmail.com.

South African Medical Journal = Suid-Afrikaanse Tydskrif Vir Geneeskunde
|June 13, 2017
PubMed
Summary

South Africa's Medicines Control Council (MCC) now regulates complementary medicines, ensuring public safety. This regulatory shift requires manufacturers to provide robust data on efficacy, safety, and shelf-life for medicine registration.

Related Experiment Videos

Last Updated: Feb 28, 2026

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Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Affairs
  • Public Health

Background:

  • Medicines regulation has evolved, emphasizing quality control from development to consumer.
  • The Medicines Control Council (MCC) in South Africa is responsible for regulating all medicines.
  • Complementary medicines were historically perceived as unregulated, despite the Medicines Act not differentiating them from allopathic medicines.

Purpose of the Study:

  • To outline the regulatory framework for complementary medicines in South Africa.
  • To highlight the MCC's mandate in ensuring public safety through medicine registration.
  • To address the challenges faced by stakeholders due to new dossier requirements for complementary medicines.

Main Methods:

  • Review of the Medicines Act and MCC regulatory practices.
  • Analysis of the implications of new dossier content requirements for complementary medicine manufacturers.
  • Examination of the MCC's role in ensuring manufacturing standards and data integrity.

Main Results:

  • The MCC now enforces stringent regulatory practices for complementary medicines.
  • Manufacturers must adhere to good manufacturing practice (GMP) standards.
  • Efficacy, safety, and shelf-life data are crucial for medicine registration.

Conclusions:

  • The era of unregulated complementary medicine in South Africa has ended.
  • MCC registration ensures complementary medicines are safe, effective, and meet quality standards.
  • Regulatory compliance is essential for market access and public health protection.