API Department (Quality Assessment)
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Assessment policy CADIFA Guidance Impurities ANVISA Guidelines Other Guidelines Pharmacopoeias ANVISA links Other links FAQ History
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Laws & Decrees

Law nº 5.991/1973 Law nº 6.360/1976 Law nº 6.437/1977 Law nº 9.782/1999 Decreto nº 8.077/2013
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General

Legislation database RDC 318/2019 RDC 283/2019 RDC 255/2018 RDC 166/2017 RDC 37/2009 RDC 204/2005
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API

RDC 362/2020 RDC 361/2020 RDC 359/2020 RDC 69/2014 RDC 57/2009 RDC 30/2008 IN 3/2013 IN 15/2009 NT 1/2016 COINS/COIFA NT 6/2015 COINS/COIFA OS 58/2019
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Drug product

RDC 301/2019 RDC 200/2017 RDC 73/2016 RDC 53/2015 RDC 37/2011 RDC 31/2010 IN 35/2019
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Guidelines

Degradation profile in drug products (PT) Statistical treatment of analytical validation (PT) Dissolution applied new, generic and similar drug products (PT) Guidance 24/2019 (CTD) (PT) Guidance 24/2019 (Anexo I) (PT) Guidance 24/2019 (Anexo II) (PT)
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FAQ

API (PT) API (EN) RDC 73/2016 RDC 166/2017 RDC 53/2015 RDC 200 (Quality) Qualification of impurities (PT)