Magister Pharmaceuticae - MPharm / Medicines (CMs) are widely available to the South African public. However, CMs have not yet been evaluated by the Medicines Control Council (MCC). The MCC has published new guidelines for the regulation of CMs, with which CM companies are required to comply. OBJECTIVE: Determine to what degree Western Herbal CM labelling complies with the MCC’s requirements. METHODS: Thirteen CM products containing recognised Western Herbal ingredients were selected from pharmacies in the northern suburbs of Johannesburg. Labelling information on the immediate and outer container labels, as well as the package inserts, was investigated. The relevant corresponding European Medicines Agency (EMA) monographs and MCC guidelines were used to assess compliance. RESULTS: None of the products complied with the product dosage section of the monographs. Furthermore, the products contained indications that were not present in the monographs. The products did not fully meet the MCC’s mandatory minimum labelling requirements, and they did not demonstrate total compliance with all of the MCC’s requirements for product labels and package inserts.

Breast cancer is the most common cancer in women worldwide and the solid tumor type for which the highest number of drugs have been approved to date. This study examines new drug approvals for breast cancer by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), based on an analysis of regulatory documents from both agencies for the period from 1995 to 2018. Of the 29 breast cancer drugs approved over this time span, 17 received positive decisions from both the FDA and EMA, including all drugs licensed after 2008. Nineteen of the 25 FDA-approved drugs, but none of the EMA approvals, benefited from special regulatory pathways (such as fast track, breakthrough therapy, or priority review). In the U.S.A., four accelerated approvals were granted (of which one, for bevacizumab, was later revoked), while only two drugs received provisional approvals following EMA review. New breast cancer drugs were approved approximately twelve months earlier in the United States than in Europe. These results suggest that a broader use of special regulatory pathways by EMA could help to accelerate access to novel drugs for European breast cancer patients.

Si le droit connaît les médicaments et les denrées alimentaires, il ne reconnaît pas les alicaments. Or, ces dernières années ont vu l’apparition et le développement, sur le marché de l’Union européenne, de « produits-frontière » c'est-à-dire de produits se trouvant à la frontière entre les médicaments et les aliments. Confrontées à un vaste conflit de qualification causé par l’ambivalence conceptuelle des « produits-frontière », les institutions de l’Union ont, au nom de la libre circulation des marchandises ainsi que de la nécessité d’une protection accrue des consommateurs et de la santé publique, entamé, dès le début des années 2000, une large harmonisation des dispositions nationales relatives à ces produits. Considérés comme aliments, leur nature particulière nécessite cependant une approche adaptative de la part du législateur européen. Cette nouvelle approche de l’aliment par le droit, favorable à la reconnaissance d’une santé alimentaire, tant convoitée par la société contemporaine, ne résout toutefois pas l’ambiguïté quant à la place à accorder aux « produits-frontière » dans le corpus juridique de l’Union européenne. / Doctorat en Sciences juridiques / info:eu-repo/semantics/nonPublished