chapter  8
29 Pages

South Africa

ByIsadore Kanfer, Roderick B. Walker, Michael F. Skinner

INTRODUCTION The Medicines Control Council (MCC) in South Africa is a statutory body that was established in terms of the Medicines and Related Substances Control Act (MRSCA), 101 of 1965, to oversee the regulation of medicines in South Africa. Applicants are required to submit evidence of quality, safety, and efficacy for new drugs and medicinal products as well as for the registration of generic (multisource) medicinal products. In the latter instance, bioequivalence (BE) data can be used as a surrogate measure of safety and efficacy. To facilitate the registration process for generic medicines, guidelines have been prepared to serve as a recommendation to applicants wishing to submit data in support of the registration of such medicines (1-4).