Regulatory Sciences, Generics and Biosimilars

Module Objectives

The aim of this module is to give students a thorough overview of the study of the continual advancement and development of the legislation, registration, regulations and science of drug discovery and the formulation of new medicines. The overall aim is to enable the student to critically appraise the principle steps of drug discovery, especially with regard to generics and biosimilars.

It aims to refresh the participants’ knowledge of the more pertinent aspects of pharmacology, molecular biology and toxicology as applied and interrogated to the production of new medicines, generics and biosimilars.

Generics and biosimilars offer more affordable health care to patients who are financially challenged. However, in principle, they should meet the required standards for quality, safety and efficacy as dictated by the laws of the country where the medicines are to be marketed. This module aims to improve the students’ understanding of these products and therefore enable quicker application assessment times.

Intended Module Learning Outcomes

On completion of this module, the student should be able to:

Determine, in detail, the differences between generics and biosimilars and what these mean or could mean for the patients taking them

Interpret the regulations of generic medicines and biosimilars, focusing on the differences between each and the differences between both and innovative medicines

Contribute to the further development of the regulations of generic medicines and biosimilars, especially those of biosimilars

Provide valuable assistance to those applicants aiming to market these two groups of medicines

Develop a set of regulations, which in broad principles could be regarded as a starter set of regulations for any country embarking for the first time on the route of registration and regulation of generic medicines and biosimilars