Before a drug can be sold, it is necessary to obtain a marketing authorization from the relevant regulator. This stamp of approval confirms that that the drug is of high quality, safe and effective. To obtain a marketing authorization, companies submit an application demonstrating that the drug consistently complies with legal and regulatory requirements and that any label claims are supported by robust scientific evidence.
The regulators' evaluation of the report is undertaken by skilled exsperts teams, including physicians, pharmacists and other scientists. In this way, healthcare professionals and patients can be confident that any drug sold, prescribed or administered as a generic, is a therapeutic equivalence of the original drug and is of the highest quality.
To obtain a marketing authorization for a generic drug, it is necessary to demonstrate that it provides the same quality, efficacy and safety as the reference innovative drug. The application includes information on the composition of the drug and a detailed description of how the active pharmaceutical ingredient and drug product are manufactured and controlled. This ensures that every batch is consistently manufactured to the required quality and is stable when stored at the recommended conditions.
In addition, there is a detailed description of the drug's development, including pharmaceutical, pre-clinical and clinical trials, to ensure that the drug is safe and efficacious. This often involves conducting studies with healthy volunteers, to demonstrate that the generic drug’s rate and extent of biological activity are the same as those of the innovative reference drug.
Obtaining a marketing authorization is, however, only the beginning of the process. Further obligations need to be fulfilled throughout the lifecycle of the drug, namely, monitoring the safety of the drug after launch.