巴西医药

法律法规 Laws & Decrees

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

总述 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)

原料药 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)

药品 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)

指南和常见问题回答 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)

http://antigo.anvisa.gov.br/en/english/api/guidelines