Understand ANVISA’s New Update and Its Impact on the Registration of Pharmaceutical Ingredients

ANVISA published, in the Official Gazette of the Union, Normative Instruction 343/2025, which brings important changes to the list of Brazilian Common Denominations (DCBs). Eight new denominations were included, and one was changed, reinforcing the need for continuous updating of companies in the health sector regarding the regulation of pharmaceutical inputs. QR Group, a specialist in health regulation, is prepared to assist companies in adapting to ANVISA’s new guidelines.

What are Brazilian Common Denominations (DCBs)?

DCBs represent the official nomenclature of drugs and active ingredients, as established by Law 9,787/1999. With the evolution of the electronic record, the concept was expanded to include inactive inputs, hyperimmune serums, vaccines, radiopharmaceuticals, medicinal plants, homeopathic and biological substances. Maintaining and updating the list is essential to ensure standardization and safety in the pharmaceutical sector.

Impacts of the Update on the Pharmaceutical Industry

With the inclusion of new denominations and the change of one of them, manufacturers, importers and distributors of pharmaceutical ingredients must adapt to the new requirements of ANVISA. The update of DCBs directly impacts drug formulation, product registration, and regulatory compliance in Brazil. Companies that are not compliant may experience delays in the process of approving and commercializing products.

How QR Group can help

QR Group acts as a strategic partner for companies that need to adapt to regulatory changes. With expertise in sanitary regulation and a highly qualified team, we offer complete support for the registration and adequacy of pharmaceutical ingredients with ANVISA.

Among the services offered are:

• Personalized consulting for registration of pharmaceutical ingredients;
• Support in the preparation and review of regulatory documentation;
• Analysis of compliance with the new DCBs;
• Intermediation with ANVISA to ensure agile and safe approval.

Access to the Updated List of DCBs

The consolidated list of Brazilian Nonproprietary Names is available in ANVISA’s Digital Library, along with current legislation, manuals and forms for inclusion, change and exclusion of names.

Contact QR Group and ensure the regularization of your products safely and efficiently!

Source: ANVISA