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Drug Registration In Brazil

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Drug Registration In Brazil

Drug Registration In Brazil

MoH

Ministry of Health, Brazil

MoH Website

https://www.gov.br/saude/en

Regulatory Authority

The Brazilian Health Regulatory Agency (ANVISA)

Link for Regulatory Authority

https://www.gov.br/anvisa/pt-br/english

Local Authorized Representative

Yes

License Validity

  • Standard approvals – Valid for 10 years initially, renewable for additional 10 year periods.
  • Approvals with preliminary evidence and commitment term – Valid for 3 years initially.
  • First renewal – Valid for 5 years.
  • Second renewal – Back to standard 10-year validity.

Regulation

  • CADIFA Guidelines
  • For New synthetic and semi-synthetic drugs, Generic drug, Similar drugs, Potentized medicines- Resolution RDC 753/2023
  • Notified medicines: Resolution RDC 576/2021
  • Specific medicines: 24/2011 and Resolution RDC 242/2018
  • OTC drugs: Resolution RDC 98/2016, Norm IN 11/2016 and Resolution RDC 242/2018
  • Herbal medicines: Resolution RDC 26/2014
  • Medicinal gases: Resolution RDC 70/2008
  • Biologic products: Resolution RDC 55/2010
  • Radiopharmaceuticals: Resolution RDC 64/2009 

Registration and Post-Approval changes Timeline

Priority Review

  • Registration-120 days.
  • Post-approval Changes- 60 days

Standard Review

  • Registration-120 days.
  • Post-approval Changes-  60 days 

New CADIFA Guidelines in BRAZIL

  • In April 2020, Brazil’s health regulatory agency, the Agência Nacional de Vigilância Sanitária (ANVISA), introduced updated standards for Active Pharmaceutical Ingredients (API), which included the new regulations known as Carta de Adequabilidade do Dossiê de Insumo Farmacêutico Ativo (CADIFA). These regulations officially took effect in August 2020, and businesses were granted a grace period of three years to adhere to them. Companies aiming to register their medicinal products in Brazil are required to acquire a CADIFA application by August 2023.
  • A CADIFA is a letter from ANVISA confirming the acceptance of an API dossier or Drug Master File (DMF). It serves as proof of compliance with Good Manufacturing Practices (GMP) for API production in Brazil. Once granted, a CADIFA can be utilized to facilitate various drug product registration submissions without requiring re-assessment.
  • Commencing in August 2023, any company desiring to register its pharmaceutical products in Brazil must secure a CADIFA. The updated regulations took effect in 2021, and CADIFA will serve as a replacement for the API Dossier or DMF (DIFA, an acronym in the local language for Active Pharmaceutical Ingredient Dossier). Obtaining a CADIFA application is free of charge for the company, and there is no requirement for renewal. Nevertheless, the DMF holder must ensure the CADIFA remains current by promptly updating it in case of any changes.

Process for Obtaining a CADIFA

The following are the main procedures for obtaining a CADIFA to register drugs in Brazil:

  1. To obtain a CADIFA, the DIFA must be submitted to ANVISA by either the DMF holder or an entity familiar with the entire DMF.
  2. The CADIFA can only be requested by the DMF holder.
  3. It is unnecessary to engage a Regulatory agent in Brazil for the CADIFA application; instead, the foreign API manufacturer can complete the process independently.
  4. Following authorization, CADIFA can be used to support multiple drug product registration applications without re-evaluation.
  5. The typical approval time for an API in Brazil for a medicinal product range from fifteen (15) to eighteen (18) months, while fixed-dose combinations have an API approval time of twenty-four (24) months.

Benefits of the CADIFA

The CADIFA presents several benefits for companies seeking drug registration in Brazil. It issues a certificate of GMP compliance for API manufacturers in Brazil, a prerequisite for registering medicinal products in the country. Once authorized, CADIFA extends its coverage to any subsequent submissions dependent on the API specified in CADIFA. This approach eliminates the necessity of re-evaluating the API dossier or DMF for each application for drug product registration.

Pharmaceutical Registration requirement and documentation in Brazil

Steps of Drugs Registration in Brazil

Step 1: Preparation and Submission of Registration Dossier to ANVISA

  1. Structure of Registration Dossier
  2. Content of Registration Dossier

Step 2:  GMP Inspection of Manufacturing Sites by ANVISA

Step 3: Local testing.

It is controlled by RDC 204/2017, Priority Pathway, Special Procedure for Rare Diseases, and RDC 200/2017, Inclusion of Certain Innovations.

 Procedure for Registering Drugs

  1. Sending the ANVISA application paperwork.
  2. The Office for New Drugs Research and Clinical Trials (GEPEC) reviews the safety and effectiveness data that applicants provide in the modules.
  3. The applicants and the Chamber of Drug Market Regulation talk about the product pricing points.
  4. ANVISA conducts GMP inspections of the production plants.
  5. Following a careful examination of the filed documentation and an inspection, the applicant is given market authorization by ANVISA.

Structure of Registration Dossier

The registration dossier in Brazil is divided into two main sections and is formatted in the eCTD format:

Part 1: Administrative Part

This section matches Module 1 and consists of gathering all local and administrative data.

Section 2: Technical Section

It is in line with Modules 2, 3, 4, and 5, which provide pre-clinical study summaries, CMC data, nonclinical data and reports, and clinical data and reports.

Module 1: Regional Administrative Information (New Drug Branded Generic Drug Similar Drug)

  1. Sanitary License of the local representative
  2. Operating Authorization letter of local representative
  3. Registration of local Pharmacist at professional counsel
  4. Petition form
  5. Justification for product registration
  6. Labeling of different presentations
  7. Mention any previous communications with ANVISA
  8. The certificate of pharmaceutical product (CPP) issued from the health authority in
  9. country of origin
  10. GMP certificates issued from the health authority in country of origin
  11. GMP certificates Issued by Brazilian Health Authority-ANVISA as per Resolution of the Board of Directors (RDC) No 214, dated February 7th, 2018
  12. Worldwide registration status
  13. Pharmacovigilance data
  14. Labels of products in Portuguese
  15. Documentation on the control of transmissible spongiform encephalopathies (TSE)

 Module 2: Overall quality summary (New Drug)

 2.1 Table of contents of Module

2.2 Introduction

2.3 Quality Overall Summary

2.4 Non-clinical Overview

2.5 Clinical Overview

2.6 non-clinical

2.7 Clinical Summary

Module 3: Quality (New Drug, Branded Generic Drug, Similar Drug)

3.1 Table of contents of Module

3.2 Body of data

3.2.1 Drug Substance

3.2.2 Drug Product

3.3 Literature references used in Module 3

Module 4: Non-Clinical study Report. (New Drug)

4.1 Table of contents of Module.

4.2 Study reports

     4.2.1 Pharmacology

     4.2.2 Pharmacokinetics

4.2.3 Toxicology

4.3 Literature references used in Module 4

Module 5: Clinical study report (New Drug)

5.1 Table of contents of Module

 5.2 Tabular listing of all clinical studies

 5.3 Clinical study reports

5.3.1 Reports of biopharmaceutic studies

5.3.2 Reports of human pharmacokinetic (PK) studies

5.3.3 Reports of human pharmacodynamic (PD) studies

5.3.4 Reports of efficacy and safety studies

5.3.5 Reports of post-marketing experience.

5.3.6 Case report forms and individual patient listings.

5.4 Literature references used in Module 5

Note: BE studies required for Branded Generic Drug Similar Drug

ANVISA Review Process of Registration Dossier

  1.  Applicant submits registration dossier to ANVISA
  2. GEPEC reviews /examines the pharmacological data, Safety, and efficacy provided in the submission dossier
  3. External consultant Activity: Advice from external consultants used on ad hoc basis
  4. Cateme Activity: Technical chamber of medicines provides expert advice
  5. The applicant and the Chamber of medicine Market Regulation (CMED) talk discuss medicine prices.
  6. ANVISA conducts GMP inspections of facilities.
  7. The medicine is authorized for sale by ANVISA.

ANVISA GMP Inspection Process

  1. Petition form completed, stamped and signed
  2. Valid GMP certificate issued by the health authority of the country of origin. Certificates issued in English or Spanish will be accepted without the need of a sworn translation.
  3. Plant Master File – AMP or Site Master File – SMF.
  4. Periodical Product Review (RPP)
  5. If available, an inspection report from additional health authorities in the country of origin

Timeline for GMP Inspection

  • occurs approximately 6 months after submitting the request for inspection to ANVISA.
  • ANVISA grants the Good Manufacturing Practice certificate to the company 45 to 60 days after inspection.

Requirements for Local Testing

  • Complete quality control testing of finished products must be carried out by the Brazilian importer in accordance with the requirements and testing procedures recognized with ANVISA for Brazil.
  • The quantity of cargo to Brazil each year determines how frequently tests are conducted:
  1. Importing more than eight shipments annually of drug samples from two batches per year to be examined.
  2. Importing fewer than eight shipments annually of drug samples from two batches per year to be tested every two years.
  • The amount of time needed for each local test is determined by the product’s requirements.

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