What is a generic drug?
A generic drug is a medicine similar to an already authorized medicine (the so-called "reference medicine"). A generic drug contains the same amount of active ingredient (or active ingredient) as the reference medicine. Generic and reference drugs are used at the same time
dosage to treat the same disease and are equally safe and effective.
The name, appearance (such as color or shape) and packaging of the generic drug are different from those of the reference medicine. Furthermore, the generic drug may contain different inactive ingredients. As with all medicines, if special precautions are to be taken for any of the inactive ingredients, these precautions must be indicated on the label and in the package leaflet of the medicine.
How is a generic drug authorized?
A generic drug, like all medicines, must obtain marketing authorization before it can be marketed. The marketing authorization is granted after a regulatory authority, such as the EMEA, has conducted a scientific assessment of the efficacy, safety and quality of the medicine.
For innovative medicines, a period in which data protection is guaranteed is required by the legislation on drugs. At the end of this period the pharmaceutical company can submit an application for marketing authorization for the generic drug.
How is a generic drug evaluated?
As the reference medicinal product has been authorized for several years, information is already available on this subject and therefore no new information is required. The legislation establishes which tests should be conducted to show that the generic drug is as safe and effective as the reference medicine. In most cases, the information provided by a bioequivalence study is sufficient. The bioequivalence study is a study aimed at demonstrating that the amount of active ingredient present in the human body is the same, regardless of whether one takes the generic drug or the reference medicine.
Generic drugs are produced following the same quality standards used for all other medicines.
Furthermore, as for all other medicines, the regulatory authorities carry out periodic inspections on the site or at the production sites.
Is the safety of generic drugs monitored?
The safety of all medicines, including generic drugs, is monitored even after the marketing authorization has been issued. Each company is required to set up a system to monitor the safety of the products it puts on the market. Regulatory authorities can also inspect this monitoring system. In general, if specific precautions are required when taking the reference medicine, the same precautions should also be taken for the generic drug.
