How to become a reference?
Understanding Drug Classification in Brazil
In today's competitive environment, whether in healthcare or any other professional sector, becoming a benchmark is a goal pursued by many. In the pharmaceutical context, this applies not only to professionals in the field but also to the medications themselves. This article explores how the constant updating of legislation and a deep understanding of drug classification in Brazil are fundamental to becoming a benchmark in both one's career and the pharmaceutical market.
The Importance of Continuous Updating for Professionals
For professionals, especially pharmacists, being a reference means always staying up-to-date on the latest news and regulatory changes. This includes a deep understanding of regulations such as... RDC 753/2022 andRDC 35/2012 From Anvisa, which regulates the registration and indication of Reference Medicines in Brazil. This knowledge not only enriches the professional foundation, but also establishes the individual as a source of trust and authority in their field.
Reference Drugs x New Drugs x Generic Drugs x Similar Drugs
According to RDC 753/2022 According to Anvisa, in Brazil, medicines are classified into three main regulatory categories for their registration: New, Generic, and Similar.
New drugs refer to molecules that are new to the country and require clinical studies with patients to prove their efficacy and safety, while generics and similar drugs generally undergo bioequivalence studies in healthy individuals. This process ensures that all medicines available on the market meet the requirements established by Brazilian legislation, and information on how each product was registered can be found on the Anvisa website.
When discussing medications, being a Reference drug has a specific technical connotation. Medications on the Reference list are those that serve as a standard for comparison and approval of generic and similar drugs, which must demonstrate bioequivalence to the Reference drug.
Having your reference medication list always at hand is very easy with the LegalPharma App… but, ultimately, how do you get on this list?
From New to Reference
If a company is interested in producing a copy of a new drug, it must submit a request to Anvisa (Brazilian Health Regulatory Agency) for the new drug to be officially recognized and listed as a reference drug. This procedure is regulated by Anvisa's RDC 35/2012. Consequently, it is common for all drugs classified as reference drugs to have initially been approved as new drugs. It is interesting to note that a reference drug can, in certain cases, be a copy (generic or similar), particularly when the original/new drug ceases to be marketed.
