Generic drugs are exact copies of original (reference) drugs, both in composition and pharmaceutical form. To be considered generic, a drug must demonstrate therapeutic equivalence with the reference drug. They have the same active ingredient and offer the same efficacy and safety, but are generally marketed at lower prices. Generic drugs are, on average, 35% cheaper than reference drugs. The greater availability and lower cost of generics helps to increase the population's access to effective treatments.

According to Brazilian legislation, the main objective of generic medicines is to guarantee the quality, safety and efficacy of these products, as well as promoting competition in the pharmaceutical market and reducing the cost of medicines for the population.

Main points of the legislation:

1. Therapeutic equivalence: The generic drug must be bioequivalent to the reference drug.
2. Interchangeability: The generic drug can be interchanged with the reference drug, provided the health professional authorizes it.
3. Information on the packaging: The packaging of the generic drug must contain clear and objective information about the product.
4. Health surveillance: Generic drugs are subject to continuous health surveillance to guarantee the quality and safety of the products on the market.

The National Health Surveillance Agency (ANVISA) is the body responsible for authorizing the registration of medicines in Brazil. In order to obtain registration, the manufacturer of the generic drug must submit all the data from the tests carried out and prove that their product meets the requirements established by the legislation.

The registration of a generic drug is a rigorous and complex process, with the aim of guaranteeing the quality, safety and efficacy of the product before it is marketed. The main stages include:

1. Choosing the reference medicine
2. Product development
3. Bioequivalence studies
4. Data analysis
5. Submission of the dossier
6. Analysis by Anvisa
7. Granting of registration

In order for ANVISA to grant registration, all the established requirements must meet the legislation, and even after registration, generic drugs are subject to ongoing health surveillance. ANVISA monitors the quality and safety of products on the market and can take appropriate action in the event of problems.

To avoid the bureaucracy of the generic drug registration process, you can count on the expertise of Stone Okamont, a company specializing in regulatory affairs. We have a team of professionals ready to assist you, so get in touch.