Regulatory Sciences and Complementary and Traditional Medicines

Module Objectives

This module is designed to set the background to complementary and traditional medicine (CTM) internationally and particularly within the African continent. This module can be broken into five main parts of 2 sessions each, which is 10 sessions overall.
During this module, the student will conceptualise the usage, practice and regulation of CTM in terms of the different norms to those typically applied to orthodox medicines. The student will also recognise the perspective of the would-be user as well as the CTM practitioner within the economic and socio-cultural context of their use of the CTM. This is in terms of the benefits of accessibility of needy patient populations to treatment and the restoration in societies of elements of traditions overshadowed during the time of colonial rules. Finally, the student will recognise the difficulties of regulating traditional medicinal systems within and outside their countries of origin.

In the tutorials, the student will look at CTM from a regulatory perspective as follows:

Although the practice of CTM is different from orthodox medicines, the regulator’s intentions and tasks are the same; that is, upholding the law of the land and ensuring the protection of users.

In this module, it is assumed that the regulatory management of CTM might not replicate the approaches to the regulatory management of orthodox medicines in North America or Western Europe, for example.

Much CTM has been adopted outside its countries of origin. Therefore, a range of experience on issues of import, export, quality management, licensing, scientific, economic, social and cultural research in addition to the regulation of professional practices and the training of practitioners will be called on for reference.

Intended Module Learning Outcomes

Describe what CTM means and how it can differ, and compare different types of CTM

Define the status of CTM in its countries of origin; that is, is it the main type of medicine or complementary to other types mainly used?

Compare and critique the regulatory controls for CTM in at least two appropriate countries of the world

Comment on the suitability of the regulations currently being drafted in South Africa for CTM

Develop a set of regulations that, in broad principles, can be regarded as a starter set of regulations for any country embarking for the first time on the route of registration and regulation of CTM

Regulatory Sciences and Complementary and Traditional Medicines
Regulatory Sciences and Complementary and Traditional Medicines