ABSTRACT

This chapter focuses on the regulatory framework that pertains to the development, marketing, manufacturer and supply of pharmaceutical and other healthcare products because of their special nature, their mode of use and potential for abuse. From the supply chain management perspective, compliance with the regulatory framework creates the access to the demand for the product. Increasingly there is pressure from regulators to show that the intended new product is sufficiently differentiated from existing drugs for it to be supported by both marketing approval and reimbursement pricing. During the product development process there will be a parallel pharmaceutical development process. The patients and relevant healthcare professionals are aware of and fully understand the product and its use and application. The marketing companies must show that their product provides a clinical benefit over any existing products or treatments before it can be made widely available through prescription.