Most of this below was discussed in the last PR, but these are the most important parts.
Cannabis Bioscience is anticipated to be granted a cannabis license through the MCC - Medicine Controls Council and Ministry of Health (see below description).
Once received, the company can LEGALLY grow, cultivate, and produce a Cannabis extract which will then be used for developing cannabis based medicines (similar to what GW Pharmaceuticals has done), all under a Government issued cannabis license
It is anticipated that through our proprietary and proven extraction process, & using live plants,the extract will be a non-psycoactive cannabis complex containing the full profile of cannabis including all of the phytonutrients, including cannabinoids, cannabinoid acids, terpenes, polyphenols. Based on clinically-proven science and bioavailability, the new cannabis complex of phytonutrients is expected to achieve pharmaceutical standards.
Part of the forthcoming responsibilities will be to work with the Government of South Africa to develop non-psychoactive cannabis medicines with an objective to have our product declassified from a Level 6 controlled substance to a Level 0 controlled medicine. This declassification would be game-changing as it will allow our non-psychoactive cannabis medicines to be sold throughout the world. We would have a unique opportunity for the global licensing, the marketing and distribution of these branded medicines
Overview
Over the last fifty years, South Africa has developed a medicines regulatory authority with internationally recognised standing.
The Medicines Control Council applies standards laid down by the Medicines and Related Substances Act, (Act 101 of 1965) which governs the manufacture, distribution, sale, and marketing of medicines. The prescribing and dispensing of medicines is controlled through the determination of schedules for various medicines and substances.
The MCC operates through external experts who are members of Council Committee structures. Most experts evaluate data sets submitted by the pharmaceutical industry for purposes of registration. Many of these evaluators are from various academic institutions, mainly medical and pharmacy schools.
The office of the Registrar provides administrative and technical support to Council and its activities. The Registrar is also an executive secretary to Council. The Registrar’s office is a Chief Directorate/Cluster, Food Control, Pharmaceutical Trade & Product Regulation, within the Department of Health. There are four Directorates, which are largely responsible for co-ordination and execution of various activities. The cluster is, therefore, secretariat to the Council.
The staff complement of the Cluster includes doctors, pharmacists, veterinarians, other scientists and administrative staff. A certain amount of technical evaluation of generic medicines is performed in-house. It is anticipated that this will increase over time as use of generic medicines increases, in line with government policy of improving access to medicines.
The Council has 9 active technical committees, with 146 members from various institutions in the country.
The structure of Council and its committees is described below. The skills of Council and its committees are written into law and include expertise in toxicology and medicine safety, clinical pharmacology, biotechnology, pharmaceutics, internal medicine, virology, pharmaceutical chemistry, neonatology, paediatrics, immunology, veterinary science, complementary medicines and law.
The Council has 9 active technical committees, with 146 members from various institutions in the country. These include the Clinical Committee, Pharmaceutical and Analytical Committee, Clinical Trials Committee, Names & Scheduling Committee, Veterinary Clinical Committee, Pharmacovigilance Committee, Biological Medicines Committee, Complementary Medicines Committee, and Legal Committee.
The Council, in considering whether a medicine is suitable for use for its intended purpose, assesses its relative risk against the benefits. The Medicines and Related Substances Act, 1965 (Act 101 of 1965), defines a medicine as any substance or mixtures of substances used or purporting to be suitable for use or manufacture or sold for use in -:
the diagnosis, treatment, mitigation, modification, or prevention of a disease, abnormal physical or mental state, or the symptoms thereof in humans, or
restoring, correcting, or modifying any somatic or psychic or organic function in humans, and includes any veterinary medicine.
All medicines for human use are subject to this law, including complementary and complementary biological medicines. Further, all veterinary medicines must be registered in terms of the Act, excluding stock remedies registered in terms of Act 36.
