The Brazilian Pharmacopeia

The 1st edition of the Brazilian Pharmacopeia was published in 1926. Since then, five editions were published. The current edition of the Brazilian Pharmacopeia is the 6th edition and was approved by Anvisa Resolution n. 298 (August 12, 2019). It is available: (link para versão em inglês).

The Brazilian Pharmacopeia is managed, reviewed and updated by the Brazilian Pharmacopeia collegiates, according to Resolution RDC No. 467 of February 11, 2021, which establishes the collegiate bodies of the Brazilian Pharmacopeia and approves the Internal Regulations of these collegiate bodies.

This Resolution establishes the 13 Thematic Technical Committees that are groups of experts in specific areas of knowledge, the Management Committee of the Brazilian Pharmacopeia and the Working Groups:

I - Management Committee;

II - Thematic Technical Committee of Brazilian Nonproprietary Name (Denominação Comum Brasileira – DCB)

III - Thematic Technical Committee of Medical Devices;

IV - Thematic Technical Committee of Pharmaceutical Specialties;

V - Thematic Technical Committee on Medicinal Gases;

VI - Thematic Technical Committee of Homeopathy;

VII - Thematic Technical Committee of Pharmaceutical Ingredients;

VIII - Thematic Technical Committee on General Methods and Chapters;

IX - Thematic Technical Committee for The Standardization of Texts;

X - Thematic Technical Committee of Medicinal Plants;

XI - Thematic Technical Committee on Biological Products and Biotechnology;

XII - Thematic Technical Committee of Compound Products;

XIII - Thematic Technical Committee of Radiopharmaceuticals;

XIV - Thematic Technical Committee on Chemical Reference Substances; and

XV - Working Groups.

Each CTT is composed of a minimum of five and a maximum of ten professionals qualified in matters related to their competence.

The products of the Brazilian Pharmacopoeia (incluir link para tabela abaixo com as edições) include the 5 compendiums below, the Brazilian Common Denominations and the Reference Standard Materials:

I - Brazilian Pharmacopoeia; access here (incluir link em inglês)

II - Brazilian Homeopathic Pharmacopoeia; (For the 3rd edition and others access here)

III - Herbal Medicines National Formulary (For the 2nd and 1st edition access here)

IV - Homeopathic Homeopathic National Formulary (For the 2nd and 1st edition access here)

V – Brazilian National Formulary (For the 2nd and 1st edition access here)

The Brazilian Pharmacopeia compendiums

The Brazilian Nonproprietary Name (Denominação Comum Brasileira – DCB)

In 1983, the first Brazilian Nonproprietary Name (Denominação Comum Brasileira – DCB) was published. Nowadays The list of The Brazilian Nonproprietary Name (DCB List) contains more than 12000 names. The List is updated 4-5 times per year.

The DCB List and more information regarding the application procedure and rules can be found in the dedicated webpage (Portuguese).

The Brazilian Pharmacopeia Chemical Reference Substances (Substâncias Químicas de Referência da Farmacopeia Brasileira – SQRFB)

The Brazilian Pharmacopeia Chemical Reference Substances (Substâncias Químicas de Referência da Farmacopeia Brasileira – SQRFB) are currently distributed by The National Institute for Quality Control in Health (Instituto Nacional de Controle de Qualidade em Saúde – INCQS).

More information regarding The SQR-FB can be found in the dedicated webpage (Portuguese).

Brazilian Pharmacopeia Coordination

Brazilian Health Regulatory Agency – Anvisa

Agência Nacional de Vigilância Sanitária – Anvisa

SIA, Trecho 5, Área Especial 57 Brasília - DF CEP: 71.205-050

Email: farmacopeia@anvisa.gov.br