Once the drug discovery phase, during which potentially interesting compounds are tested for their non-clinical characteristics, the clinical phases (early to late phase) are initiated to further test the safety and efficacy of the drug candidate. After successful clinical trials, marketing approval for a medicinal product must be sought through the submission of a marketing authorization.
When the marketing authorization is granted by the competent authorities, commercialization of the medicinal product can begin, but through variation post-approval amendments will continue to be submitted by the regulatory affairs team, to ensure the dossier being approved by regulators is always updated.
In the next section, we will take a closer look at the different phases of the lifecycle of a drug and the role Regulatory Affairs plays throughout the pharmaceutical industry.
