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Agência Nacional de Vigilância Sanitária

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Anvisa Guidelines Anvisa Guidelines

Laws & Decrees

  • Law nº 6.360/1976
  • Law nº 6.437/1977
  • Law nº 9.782/1999
  • Decree nº 8.077/2013

General

  • Guidelines Database (Portuguese)
  • RE 899/2003 (Analytical validation - Portuguese)
  • RDC 37/2009 (Officially Recognized Compendia - Portuguese)
  • RDC 255/2018 (ANVISA Statute - Portuguese)
  • RDC 283/2019 (Nitrosamines - Portuguese)
  • RDC 166/2017 (Analytical Validation - Portuguese)
  • OS 2/2013 (Clarifications about API stability studies - Portuguese)
  • OS 58/2019 (Simplified procedure for APIs - Portuguese)

Active pharmaceutical ingredient

  • RDC 30/2008 (API registry - Portuguese)
  • RDC 57/2009 (API marketing authorization - English)
  • RDC 45/2012 (API stability studies - English)
  • RDC 69/2014 (API GMP - Portuguese)
  • Normative Instruction (IN) 15/2009 (List 1 of APIs subject to marketing authorization - English)
  • Normative Instruction (IN) 3/2013 (List 2 of APIs subject to marketing authorization - English)
  • Technical Note (NT) 6/2015 COINS/COIFA (Starting material - Portuguese)
  • Technical Note (NT) 1/2016 COINS/COIFA (Mixture of solvents - Portuguese)

 

 


Drug product

  • RDC 48/2009 (Post-approval changes of drug products - Portuguese - Revoked)
  • RDC 17/2010 (Drug product GMP - Portuguese)
  • RDC 31/2010 (Pharmaceutical equivalence - Portuguese)
  • RDC 37/2011 (Biowaiver - Portuguese)
  • RDC 60/2014 (New and Generic drug products - Portuguese) - Revoked
  • RDC 73/2016 (Post-approval changes of drug products - Portuguese)
  • RDC 200/2017 (New and Generic drug products - Portuguese)

Guidance documentos and FAQs

  • FAQ - APIs (English)
  • FAQ - APIs (English) - pdf
  • Guidance document - Degradation profiles of drug products (Portuguese)
  • FAQ - RDC 73/2016 (Portuguese)
  • Guidance document - Statistical analysis applied to analytical validation (Portuguese)
  • FAQ - RDC 166/2017 (Portuguese)
  • FAQ - RDC 53/2015
  • FAQ - Marketing authorization of drug products - Quality/CMC (Portuguese)
  • Guidance document - Dissolution applied to generic and new drug products (Portuguese)

 

 

Other Guidelines Other Guidelines

  • M4Q (CTD - Quality)
  • Q1A(R2) - Stability
  • Q1B - Photostability
  • Q1E - Stability - Evaluation
  • Q2(R1) - Analytical validation
  • Q3A(R2) - Impurities in APIs
  • Q3B(R2) - Impurities in drug products
  • Q3C(R7)- Residual solvents
  • Q3D(R1) - Elemental impurities
  • Q6A - Specifications
  • Q6A - Decision trees
  • Q7 - GMP APIs
  • Q11 - Development of APIs
  • Q11 - Q&A
  • M7(R1) - Mutagenic impurities

  • Prequalification of generic drug products (TRS 970 Annex 4)
  • Guidance on amendments to APIs
  • Guidelines on variations to a prequalified product (TRS 981 Annex 3)
  • Use of ICH Q3D Guideline in the Assessment of Active Pharmaceutical Ingredients Master Files (APIMFs)

  • Guideline on the chemistry of active substances
  • Guideline on Active Substance Master File Procedure
  • Variations (2013/C 223/01)
  • Guideline on stability testing for applications for variations to a marketing authorisation
  • Starting material (reflection paper)
  • Residual solvents - Annexes
  • Guideline on setting specifications for related impurities in antibiotics
  • Qualified Person (QP) declaration template
  • Sterilisation of the medicinal product, active substance, excipient and primary container (date for coming into effect: 01/10/2019)

  • Content of the dossier for chemical purity and microbiological quality (in effect until December 2018)
  • Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopeia monographs (in effect until December 2018)
  • Suspension or withdrawal of a certificate of suitability
  • Implementation of ICH Q3D in the Certification Procedure
  • Content of the dossier for chemical purity and microbiological quality (implementation: January 2019)
  • Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopeia monographs (implementation: January 2019)

  • All Guidances for Drugs
  • ANDAs: Pharmaceutical Solid Polymorphism

  • Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
  • Use of Certificates of Suitability as supporting information in Drug Submissions
  • Post-Notice of Compliance (NOC) Changes: Quality Document
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