New Anvisa Tool Brings Transparency to the Brazilian Drug Registration Process

Anvisa has just made available an online dashboard that allows users to consult the active ingredients of drugs with registration requests still under analysis. The tool is an innovation that promotes transparency in the regulatory process, offering a detailed view of the different categories of drugs, including generics, biologicals, herbal medicines, and others. With monthly updates, the dashboard is an effective way to monitor the status of registration requests, reinforcing Anvisa’s commitment to the Access to Information Law. QR Group, a specialist in Drug Registration Process, helps companies ensure compliance and efficiency in this process.

Check it online now at this link.

How Anvisa’s New Dashboard for Consulting Active Ingredients Works

Anvisa’s new tool allows interested parties to consult, in a practical way, the active ingredients submitted for evaluation, organized by regulatory category. The list is updated monthly and reflects registration requests for which the agency has not yet published a decision. This initiative is part of Anvisa’s efforts to increase transparency in the regulatory process, in compliance with the Access to Information Law.

Impacts of the New Tool on the Pharmaceutical Industry and Drug Registration Process

With this transparency, companies in the pharmaceutical sector can monitor the competition and plan their market strategies in a more informed manner. QR Group offers support to ensure that your company is aligned with best practices in the drug registration process.

Exclusions and Particularities of the Drug Registration Process Panel

The panel does not include clone drugs, which follow the simplified analysis procedure (RDC 31/2014). These drugs, with the same composition and manufacturer as a parent drug, can be consulted separately on Anvisa’s portal.

Conclusion

With the publication of the new active ingredient consultation panel, Anvisa reinforces its commitment to transparency and efficiency in drug registration. For companies seeking to ensure compliance in Brazil, QR Group offers specialized consultancy, helping to navigate Anvisa’s regulatory process with confidence.

If your company operates in the pharmaceutical sector and is looking to register medicines with Anvisa, contact QR Group. Our specialized team ensures compliance and agility in the registration process, facilitating your entry into the Brazilian market.

Glossary:

• Clone medicines: Medicines registered in a simplified manner, based on another medicine that has already been approved, differing only in details such as name or packaging.
• Active ingredient: Substance responsible for the therapeutic effect of a medicine.
• Access to Information Act: Legislation that guarantees the transparency of public information in Brazil.

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