Table 2 Definition of types of medicines
From: Recall of substandard medicines in Brazil during the period 2010–2018
Type of medicine | Definition |
|---|---|
Reference | An innovative product registered with ANVISA and marketed in the country, whose effectiveness, safety and quality were scientifically proven by the competent federal agency at the time of register |
Generic | A generic drug is defined as a drug with the same active pharmaceutical ingredient (API), dosage form, safety, quality, and efficacy as the original proprietary drug, with which it can be interchangeable |
Similar | Medicine that contains the same API, dosage form, strength, indication, and posology of the original proprietary drug but is identified by a brand name, with which it can be interchangeable with reference medicine |
Specific | Specific medicines are pharmaceutical products, technically obtained or prepared, with a prophylactic, curative or palliative purpose that do not fall into the categories of new, generic, similar, biological, herbal or notified medicine and whose active substance(s), regardless of nature or origin, is not subject to bioequivalence testing against a comparable product |
New | These are innovative medicines that are registered in the country for the first time. Generally, its active principles are new, synthetic or semi-synthetic molecules, associated or not with other active principles |
Herbal | These are obtained with the exclusive use of active vegetable raw materials |
Biological | Biological medicines are complex molecules of high molecular weight obtained from biological fluids, tissues of animal origin or biotechnological procedures through manipulation or insertion of other genetic material (recombinant DNA technology) or alteration of genes that occurs due to irradiation, chemicals or forced selection |
Radiopharmaceutical | Pharmaceutical preparations for therapeutic purposes which, when ready for use, contain one or more radionuclides |
Simplified notification | They are low-risk drugs for which companies do not need to submit documentation and wait for the register to be evaluated and published; Companies only inform ANVISA that they are producing the drug, which must be on the list of low-risk drugs subject to simplified notification (E.g. sodium chloride solution, aluminum hydroxide suspension, folic acid solution, and chlorhexidine hydrochloride solution) |