Brazil's Pharmaceutical Regulations

Pharmaceuticals in Brazil are governed by ANVISA, the Agência Nacional de Vigilância Sanitária, under the Brazilian Ministry of Health. ANVISA is an autonomous arm of the government and is responsible for the protection of the public’s health. Anvisa categorizes drugs into the following: new synthetic drugs, generic drugs, similar drugs (a generic drug marketing with a brand name), potentized medicines (homeopathic, anthroposophic and antihomotoxic), specific medicines, notified medicines (low risk), OTC (over the counter) drugs, herbal medicines, medicinal gases, biologic products and radiopharmaceuticals.

Table of Contents

REGISTRATION
Document Number Document Title Issued by Description Available Languages Download
RDC No. 55/2010 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 55, OF DECEMBER 16th, 2010 Anvisa It provides for the registration of new biological products and biological products and gives other measures. English/Portuguese For Sale
RDC No. 263/2019 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 263, OF FEBRUARY 4th, 2019 Anvisa Provides for the registration of radiopharmaceuticals of ‘consecrated use’, manufactured in national territory and on the amendment of the RDC No. 64, of December 18th, 2009, which provides for the registration of Radiopharmaceuticals. English/Portuguese For Sale
RDC No. 31/2014 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 31, OF MAY 29th, 2014 Anvisa Covers the simplified procedure for registration, post-registration and registration renewal applications for generic, similar, specific, dynamized, herbal and biological medicinal products and other measures. English/Portuguese For Sale
RDC No. 204/2017 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 204, OF DECEMBER 27th, 2017 Anvisa Features on the framework in the priority category, petitions of registration, post- registration and prior consent in clinical research of drugs. English/Portuguese For Sale
RDC No. 242/2018 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 242, OF JULY 26th, 2018 Anvisa Alters Resolution - RDC No. 24 of June 14th, 2011, Resolution - RDC No. 107 of September 5th, 2016, the Normative Instruction – IN No. 11 of September 29th, 2016 and Resolution - RDC No. 71 of December 22nd, 2009 and regulates the registration of vitamins, minerals, amino acids and proteins for oral use classified as specific medicines. English/Portuguese For Sale
RDC No. 98/2016 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 98, OF AUGUST 1st, 2016 Anvisa Provides for the criteria and procedures for classifying medicines as non-prescription and reframing them as prescription medicines, and other measures. English/Portuguese For Sale
SENATE BILL No. 530/2013 SENATE BILL No. 530 OF 2013 Brazilian Senate Institutes the National Policy for Rare Diseases within the scope of the Unified Health System; amends Law No. 6,360, of September 23, 1976, to provide for registration and import, by individuals, of orphan medicines; and amends Law 8,080, of September 19, 1990, to provide different criteria for the evaluation of orphan medicines. English/Portuguese For Sale
CLINICAL STUDIES
Document Number Document Title Issued by Description Available Languages Download
RDC No. 318/2019 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 318, OF NOVEMBER 6th, 2019 Anvisa Establishes the criteria for conducting Stability Studies for active pharmaceutical ingredients and non-biological drugs and makes other arrangements. English/Portuguese For Sale
RDC No. 205/2017 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 205, OF DECEMBER 28th, 2017 Anvisa Establishes a special procedure for the consent of clinical trials, certification for good manufacturing practices and registration of new drugs for treatment, diagnosis or prevention of rare diseases. English/Portuguese For Sale
RDC No. 204/2017 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 204, OF DECEMBER 27th, 2017 Anvisa Features on the framework in the priority category, petitions of registration, post- registration and prior consent in clinical research of drugs. English/Portuguese For Sale
IN No. 45/2019 NORMATIVE INSTRUCTION No. 45, OF AUGUST 21st, 2019 Anvisa Provides for Good Manufacturing Practices complementary to Experimental Drugs. English/Portuguese For Sale
RDC No. 9/2015 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 9, OF FEBRUARY 20th, 2015 Anvisa Provides for the Regulation for conducting clinical trials with medicines in Brazil. English/Portuguese For Sale
GOOD MANUFACTURING PRACTICE ( GMP)
Document Number Document Title Issued by Description Available Languages Download
RDC No. 234/2018 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 234, OF JUNE 20th, 2018 Anvisa Regulates the subcontracting of production stages, control analysis for quality control, control of transport and storage of medicines and biological products and which gives other provisions. English/Portuguese For Sale
IN No. 45/2019 NORMATIVE INSTRUCTION No. 45, OF AUGUST 21st, 2019 Anvisa Provides for Good Manufacturing Practices complementary to Experimental Drugs. English/Portuguese For Sale
IN No. 37/2019 NORMATIVE INSTRUCTION No. 37, OF AUGUST 21st, 2019 Anvisa Provides for Good Manufacturing Practices complementary to Radiopharmaceutical medicines. English/Portuguese For Sale
RDC No. 301/2019 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 301, OF AUGUST 21st, 2019 Anvisa Provides for the General Good Medicines Manufacturing Practices Guidelines. English/Portuguese For Sale
IN No. 32/2019 NORMATIVE INSTRUCTION - IN No. 32, OF APRIL 12th, 2019 Anvisa Provides for the procedures, flows, instruments and schedule related to the fulfillment, by states, the Federal District and municipalities, of the requirements for delegating inspection to verify the Good Manufacturing Practices of manufacturers of active pharmaceutical ingredients, health products of risk class III and IV and medicines, except medicinal gases, for the purposes of issuing the Operating Authorization and the Good Manufacturing Practices Certificate. English/Portuguese For Sale
RDC No. 69/2014 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 69, OF DECEMBER 8th, 2014 Anvisa Provides for Good Manufacturing Practices for Active Pharmaceutical Ingredients. English/Portuguese For Sale
RADIOPHARMACEUTICALS
Document Number Document Title Issued by Description Available Languages Download
RDC No. 263/2019 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 263, OF FEBRUARY 4th, 2019 Anvisa Provides for the registration of radiopharmaceuticals of ‘consecrated use’, manufactured in national territory and on the amendment of the RDC No. 64, of December 18th, 2009, which provides for the registration of Radiopharmaceuticals. English/Portuguese For Sale
IN No. 37/2019 NORMATIVE INSTRUCTION No. 37, OF AUGUST 21st, 2019 Anvisa Provides for Good Manufacturing Practices complementary to Radiopharmaceutical medicines. English/Portuguese For Sale
ORPHAN DRUGS
Document Number Document Title Issued by Description Available Languages Download
SENATE BILL No. 530/2013 SENATE BILL No. 530 OF 2013 Brazilian Senate Institutes the National Policy for Rare Diseases within the scope of the Unified Health System; amends Law No. 6,360, of September 23, 1976, to provide for registration and import, by individuals, of orphan medicines; and amends Law 8,080, of September 19, 1990, to provide different criteria for the evaluation of orphan medicines. English/Portuguese For Sale

GRP WHITEPAPER: REGISTRATION OF RADIOPHARMACEUTICALS IN BRAZIL

ANVISA classifies radiopharmaceuticals in the following 3 categories: 1. Ready-to-use radiopharmaceuticals; 2. Non-radioactive components used with radioactive components; 3. Radionuclides, including eluates of radionuclide generators.

Fast track registration of COVID-19 vaccine in Brazil

GRP WHITEPAPER: FAST-TRACK REGISTRATION OF COVID-19 VACCINES IN BRAZIL

On 03/18/2020, Anvisa published a new regulation (RDC 348/2020), that defines the conditions of the priority review for the registration of covid-19 Vaccines .

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