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.
REGISTRATION
| Document Title | Description | Issued by | Available Languages | Download |
|---|---|---|---|---|
| RDC No. 204/2017: Framework for Priority in the Registration, Post-Registration and Prior Consent in Drug Clinical Research | The Resolution outlines the criteria and procedures for the priority registration, post-registration and prior consent in clinical research of drugs. | Anvisa | English | For Sale |
| RDC No. 55/2010: Registration Process of Biological Products | This Resolution aims to establish the minimum requirements for the registration of new biological products and biological products in the country, in order to ensure the quality, safety and efficacy of these medicines. | Anvisa | English | For Sale |
| RDC No. 31/2014: Registration for Generic, Similar, Specific, Dynamized, Herbal and Biologic Medicinal Products (Simplified Procedure) | This Resolution applies to applications for registration, post-registration and registration renewal of generic, similar, specific, dynamized, herbal and biologic medicinal products. | Anvisa | English | For Sale |
| RDC No. 98/2016: Classification Criteria and Procedures of Non-prescription Medicine Medication | This Resolution establishes the criteria and procedures for the classification of medicines as non-prescription (MIPs), the reframing of these medicines as under prescription, and for the proper adequacy of the registration. | Anvisa | English | For Sale |
| RDC No. 242/2018: The Registration of Vitamins, Minerals, Amino Acids and Proteins classified as Specific Medicines for oral use | This resolution applies to Specific Medicines; they are medicines based on vitamins and/or minerals and/or amino acids and/or isolated proteins or combined with each other for oral use with well-established therapeutic indications and different from those established for food supplements. This resolution does not apply to food supplements included in the scope of Resolution RDC No. 243 of 26 July 2018 or its updates which do not have a therapeutic indication. | Anvisa | English | For Sale |
CLINICAL STUDIES
| Document Title | Description | Issued by | Available Languages | Download |
|---|---|---|---|---|
| RDC No. 205/2017: Special Procedure for the consent of Clinical Trials, Good Manufacturing Practices Certification and New Drug Registration for the treatment, diagnosis or prevention of Rare Diseases | The Resolution provide the special procedure for the consent of clinical trials to be conducted in Brazil for the evaluation of drugs for rare diseases; the certification for good manufacturing practices (GMP) applicable to drugs for rare diseases; and the health registration of new drugs for rare diseases. | Anvisa | English | For Sale |
| RDC No. 204/2017: Framework for Priority in the Registration, Post-Registration and Prior Consent in Drug Clinical Research | The Resolution outlines the criteria and procedures for the priority registration, post-registration and prior consent in clinical research of drugs. | Anvisa | English | For Sale |
| RDC No. 9/2015: Regulation for conducting Clinical Trials with Medicines in Brazil | This Resolution aims to define the procedures and requirements for conducting clinical trials with medicines, including the submission of the Drug Clinical Development Dossier (DDCM) to be approved by Anvisa. | Anvisa | English | For Sale |
| RDC No. 318/2019: Criteria for conducting Stability Studies for Active Pharmaceutical Ingredients and Non-Biological drugs | This Resolution establishes the criteria for conducting the Stability Studies of active pharmaceutical ingredients (IFAs), and new, innovative, generic, similar, streamlined, specific, simplified reporting, phytotherapeutic and radiopharmaceuticals. | Anvisa | English | For Sale |
| IN No. 20/2017: Good Clinical Practices Inspection Procedures for Drug Clinical Trials | Normative No.20 aims to establish inspection procedures to harmonize, guide and verify the compliance with the Good Clinical Practices (GCP) in clinical trials with drugs. | Anvisa | English | For Sale |
| IN No. 45/2019: Good Manufacturing Practices for Experimental Drugs used in Clinical Trials | This Normative Instruction is intended to adopt the Good Practice Guidelines for the Manufacturing of Experimental Drugs from the Pharmaceutical Inspection Cooperation Scheme, PIC/S, as complementary requirements to be followed in the manufacture of experimental drugs in addition to the General Good Practice Guidelines for Drug Manufacturing. | Anvisa | English | For Sale |
GOOD MANUFACTURING PRACTICE ( GMP)
| Document Title | Description | Issued by | Available Languages | Download |
|---|---|---|---|---|
| RDC No. 301/2019: Good Medicines Manufacturing Practices Guidelines. | This Resolution adopts the general guidelines of Good Medicines Manufacturing Practices of the Pharmaceutical Inspection Cooperation Scheme, PIC/S, as minimum requirements to be followed in the manufacture of medicines. | Anvisa | English | For Sale |
| RDC No. 234/2018: Rules for Subcontracting: Production stages, Control Analysis for Quality Control, Control of Transport and Storage of Medicines and Biological Products | This resolution provides rules for subcontracting production stages, control analysis of transport and storage of medicines and biological products. | Anvisa | English | For Sale |
| RDC No. 69/2014: Good Manufacturing Practices for Active Pharmaceutical Ingredients (API). | This Resolution establishes the procedures and practices that the manufacturer must apply in order to assure that its facilities, methods, proceedings, systems and controls used on the manufacturing of active pharmaceutical ingredients are adequate in a way to guarantee its quality and allow its use on the preparation of pharmaceutical products. | Anvisa | English | For Sale |
| IN No. 37/2019: Good Manufacturing Practices of Radiopharmaceutical Medicines. | This Normative Instruction aims to adopt the guidelines for Good Manufacturing Practices for Radiopharmaceutical Medicines of the Pharmaceutical Inspection Cooperation Scheme, PIC/S. | Anvisa | English | For Sale |
| IN No. 32/2019: Inspection Processes and Requirements to verify the Good Manufacturing Practices of manufacturers of Active Pharmaceutical Ingredients, Health Products of risk class III and IV and Medicines. | This Normative Instruction establishes the procedures, flows, instruments and schedule related to compliance Inspection Processes and Requirements to verify the Good Manufacturing Practices of manufacturers of active pharmaceutical ingredients, health products of risk class III and IV and medicines. | Anvisa | English | For Sale |
| IN No. 45/2019: Good Manufacturing Practices for Experimental Drugs used in Clinical Trials. | This Normative Instruction is intended to adopt the Good Practice Guidelines for the Manufacturing of Experimental Drugs from the Pharmaceutical Inspection Cooperation Scheme, PIC/S, as complementary requirements to be followed in the manufacture of experimental drugs in addition to the General Good Practice Guidelines for Drug Manufacturing. | Anvisa | English | For Sale |
RADIOPHARMACEUTICALS
| Document Title | Description | Issued by | Available Languages | Download |
|---|---|---|---|---|
| RDC No. 263/2019: Registration of Radiopharmaceuticals of manufactured in National Territory. | The purpose of this Resolution is to establish the minimum requirements for the registration as a medicinal product of radiopharmaceuticals of consecrated use, manufactured in the national territory. | Anvisa | English | For Sale |
ORPHAN DRUGS
| Document Title | Description | Issued by | Available Languages | Download |
|---|---|---|---|---|
| RDC No. 205/2017: Special Procedure for the consent of Clinical Trials, Good Manufacturing Practices Certification and New Drug Registration for the treatment, diagnosis or prevention of Rare Diseases | The Resolution provide the special procedure for the consent of clinical trials to be conducted in Brazil for the evaluation of drugs for rare diseases; the certification for good manufacturing practices (GMP) applicable to drugs for rare diseases; and the health registration of new drugs for rare diseases. | Anvisa | English | 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.
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 .