Abstract

Drug development is a complex, highly regulated process designed to ensure that new medicines are safe, effective, and manufactured to consistent quality standards before reaching patients. In the US and the EU, regulatory oversight is primarily provided by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively. Although both regulatory systems share common scientific principles, they differ in their regulatory procedures, clinical trial authorisation processes and marketing approval pathways.

This article, aimed at those looking to enter the regulatory affairs profession or those who have recently secured their first regulatory role, provides an accessible overview of the key stages of drug development, including discovery, target product profile development, chemistry manufacturing and controls (CMC), preclinical studies, clinical trials and regulatory submissions. It also highlights the role that regulators play throughout the development lifecycle and introduces common regulatory designations used to accelerate the development of medicines addressing serious or unmet medical needs.

It is important to recognise that drug development is not a strictly linear process, and development strategies are often tailored to the specific product and therapeutic context. Therefore, the examples discussed represent typical approaches rather than universal pathways.