A generic medicine is a medicine similar to an already authorized drug (the so-called “brand or reference medicine”). A generic medicine contains the same amount of active ingredient (or active ingredients) of the reference medicine. Generic and reference medicine are used at the same dosage to treat the same disease and are equally safe and effective.
The designation, appearance (such as color or shape) and the generic medicine packaging are different from those of the reference medicine. Furthermore, the generic medicine may contain different inactive ingredients. As with all medicines, if special precautions for any of the inactive ingredients are necessary, these precautions should be noted on the label and package leaflet of the medicinal product.
How is a generic medicine authorized?
A generic medicine, like all medicines, must obtain a marketing authorization before it can be marketed. The marketing authorization is granted after a regulatory authority, such as the EMEA, has conducted a scientific evaluation of the efficacy, safety and quality of the medicinal product.
For medicinal products, a period in which data protection is guaranteed is laid down in the legislation on medicines. At the end of this period the pharmaceutical company can submit an application for marketing authorization for the generic medicine.
How is a generic medicine evaluated?
Since the reference medicinal product has been authorized for several years, information on this is already available and therefore it is not necessary to present new ones. The legislation establishes which examinations must be conducted to show that the generic medicine 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 to show that the amount of active substance present in the human body is the same, regardless of whether you take the generic medicine or the reference medicine.
Generic medicines are produced according to the same quality standards used for all other medicines.
The regulatory authorities also perform, as for all other medicines, periodic inspections at the site or at the production sites.
Is the safety of generic medicines monitored?
The safety of all medicines, including generic medicines, is also monitored following the granting of the marketing authorization. Each company is required to set up a system to monitor the safety of the products it places on the market. Regulatory authorities may also subject this monitoring system to inspection.
In general, if it is necessary to take specific precautions when taking the reference medicine, the same precautions should also be taken for the generic drug.