巴西ANVISA原料药的各种英文指南汇总
浏览1711+
法律法规 Laws & Decrees
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
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