MCC or the Medicines Control Council is the name of the medical devices and Pharmaceuticals Regulation Body in South Africa. It is a statutory body which supervises and oversees the production procedure and the ingredient use in medicines and medicinal devices, by firms operational in South Africa. It also sees through the clinical trials of the drugs and medical products on animals and human volunteers; and following its satisfaction in the matters of health and safety, the company (whose products were tested) is registered. Once a firm is included in the list of registered companies, the MCC carries out periodic inspections to prevent the adoption of any unsavoury practices. Their registration guidelines include the following:
1. The claims which are made for the medicine with regard to the indications for its use should be substantiated in reality. These claims and indications must appear on the package insert which must accompany each pack of a medicine.
2. Approval of registration for a firm is based on these claims after MCC evaluation of the scientific and clinical data has been provided to support the claims. In addition to it, a Patient Information Leaflet needs to be made available to the patient taking the medicine, which must also be compiled by the company and approved by the MCC.
3. Specifications and quality control procedures for all the raw materials and packing materials, as well as the final dosage form in the final sales package, should be specified. All of these must be described in exact detail with the specifications and control procedures described in a pin-point manner.
4. A validation program is needed to ensure that each component and processes produce drugs/food products of a consistent quality every time. And that includes a stability testing program to ensure that the product fully retains its quality parameters throughout the duration of the shelf life of the product.
5. A Site Master File must be provided which contains specified details of the actual factory where the medicine was manufactured.
6. In case of innovative medicines, all details of the results of the pharmaceutical [laboratory], animal and human testing procedures, must be supplied or submitted. These include: Data which was generated throughout the product development from the initial stage tests done. This is required to determine the absorption, distribution, metabolism and excretion processes of the drug in animals and healthy human volunteers. And also for the results obtained in clinical trials in sick patients.
7. The studies might be carried out in South Africa or in any other country, but the data must be read, evaluated and approved by the MCC for the final registration procedure to follow through.
8. In the case of generic medicines, the applicant firm or manufacturer must provide proof that the product’s therapeutic or healing capacities are somehow greater or enhanced in comparison to the originator’s product. This can be done in the way of conducting comparative clinical trials.
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