Anvisa Guidelines
Laws & Decrees
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
- 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
- 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)
