CRITERIA USED BY ANVISA TO APPROVE DRUGS

Safety is one of the pillars of regulatory assessment. ANVISA requires companies to present robust data on the possible adverse effects and toxicity of the drug under study. This data must be obtained through pre-clinical studies) and clinical studies, carried out in accordance with Good Clinical Practice (GCP).

During the analysis, the following are assessed:

• Acute and chronic toxicity
• Drug interactions
• Side effects
• Risk-benefit profile

ANVISA considers not only the occurrence of adverse events, but also their severity and frequency. A drug will only be approved if the benefits of its use clearly outweigh the risks identified.

Another fundamental criterion is proof of therapeutic efficacy. The developer needs to demonstrate that the drug has the desired effect in treating the proposed disease or condition. This is done through controlled clinical trials, usually in three phases:

• Phase I: Evaluates safety and dosage in small groups of healthy volunteers.
• Phase II: Investigates initial efficacy and side effects in a larger group of patients.
• Phase III: Compares the new drug with existing treatments on a large scale.

ANVISA analyzes the results of these studies based on rigorous statistical and scientific criteria. The main clinical endpoints must be clearly defined and clinically relevant. Medicines with proven efficacy have a greater chance of approval, as long as they do not present unacceptable health risks.

The quality of a medicine concerns its composition, stability, purity and manufacturing process. In order to be approved, the drug must comply with Good Manufacturing Practices (GMP), a set of rules that guarantee that the product is manufactured in a controlled and standardized manner.

ANVISA requires the manufacturer to demonstrate:

• Validation of processes and analytical methods
• Control of raw materials and intermediate products
• Stability studies
• Microbiological and physical-chemical control
• Complete documentation of the technical dossier

In addition, the agency carries out inspections at manufacturing facilities, both in Brazil and abroad, to check that conditions meet the required standards. Quality is a crucial factor, as it guarantees that the medicine will maintain its efficacy and safety throughout its shelf life.

At Stone Okamont, we understand the complexity of this process and offer pharmaceutical companies complete regulatory support, from preparing the dossier to liaising with ANVISA. Our aim is to speed up access to innovative and safe medicines for the population, always in compliance with current regulations. If you work in the regulated sector and need support to register your medicine in Brazil, get in touch with our team. We are ready to turn regulatory challenges into strategic solutions.