English

Abstract

To some Cannabis is antisocial anathema, to others it is a harmless sedative-hypnotic, or narcotic analgesic and to others it occupies a cultural position as religious sacrament. Some fear its use leads to psychosis and addiction; to others still it is a legal anomaly and should be decriminalized. Whatever the case may be, in Africa where Cannabis is a recreational drug. It is caught in a bizarrely legal and regulatory maze. Regulations are changing internationally and the Cannabis industry is growing. African, National Medicines Regulatory Authorities, NMRs, have to catch up. But unfortunately some lack competent professionals who require to understand regulatory science, RS, in general, and in particular as it pertains to cannabis products with complex pharmacology. RS is “a range of scientific disciplines that are applied - intellectually and practically - to the quality, safety and efficacy assessment of medical products and that inform regulatory decision making, throughout the life cycle of a medical/health product”. RS helps to answer the following questions: Is there a pathway that will lead cannabis to mainstream medicine in Africa? Will cannabis as a botanical agent have to follow the same time-honoured process that any pharmaceutical must attain to receive regulatory approval? There is no doubt the cannabis and regulatory sciences are going to influence the future shaping and implementation of pharmaceutical medicine laws and regulations in Africa. The aim of the article is to highlight the key regulatory science challenges, in Africa, that belong to either a societal or a biomedical sphere regarding Cannabis for adult use or medicinal purposes or nutrition. Key words:  Cannabis, regulatory science, challenges, Africa.