COMPLETE GUIDE TO REGISTERING MEDICINES WITH ANVISA

The registration of medicines is a legal and technical public act, carried out by ANVISA, which authorizes the marketing of a medicine in the national territory. This registration certifies that the product meets all the quality, safety and efficacy criteria established by Brazilian legislation. The registration requirement establishes the specific procedures and requirements for registering new, generic, similar and specific medicines, among others. Without registration, a medicine cannot be legally produced or marketed in Brazil. In addition, registration is valid for 10 years and can be renewed upon proof that the product continues to meet current regulatory requirements.

ANVISA classifies medicines into several categories, each of which has different requirements for the registration process. The main categories are

• New Drug: contains a molecule that has never been used in Brazil before. It requires complete clinical studies into efficacy and safety.
• Generic Drug: has the same active ingredient, pharmaceutical form, route of administration, posology and therapeutic indication as the reference drug.
• Similar Drug: is equivalent to the reference drug, but may differ in characteristics such as color and shape.
• Biological Medicines: products derived from living organisms. They require more complex dossiers and comparability studies.
• Specific Medicines: a category for medicines that do not fit into the other definitions, such as herbal medicines and homeopathic medicines.

A correct understanding of the category of medicine is crucial, as it has a direct impact on the documentation required and the regulatory strategy adopted.

ANVISA has made efforts to reduce the time it takes to analyze drug registrations, mainly through programs that speed up the process for priority drugs. However, the average time for registration can vary from 12 to 24 months, depending on the category and the quality of the documentation submitted.

At Stone Okamont, we understand that each regulatory project is unique and requires a personalized approach. Our team of experts acts with excellence and precision at every stage of the process, from the classification of the drug to the submission of the dossier, including liaison with ANVISA and post-registration support. If you want to register a drug in Brazil safely and quickly, rely on those with proven experience in the regulatory market. Contact Stone Okamont.