Brazilian Health Regulatory Agency – ANVISA

API Registration Department – COIFA


The marketing authorisation of active pharmaceutical ingredients (RDC nº 57/2009) requires all parties involved in this complex and dynamic process to be aligned in terms of legal requirements, without, however, compromising the opportunities for innovation in the work process.

The most recurrent deficiencies – both technical and procedural – observed by our quality assessors have been taken into consideration in the construction of this website. Its ultimate goal is to facilitate the relationship between ANVISA and applicants/API manufacturers. The content was divided in tabs, so as to allow for a quick and intuitive navigation.

The tab Assessment Policy CTD - 3.2.S contains the list of documents that should be provided, as well as technical considerations about the main topics. The Assessment Policy was further divided in Sections which are equivalent to those of ICH M4Q (CTD - Quality). Although not mandatory, it is recommended that drug master files be submitted in CTD format, since it is a widely recognized standard. Additionally, it is the format which ANVISA intends to adopt with the revision of the API regulation.

The tab Limits allows limits for impurities (organic, residual solvents and mutagenic) as well as BCS classification of APIs to be verified. The procedure is self-explanatory.

The tab Guidelines contains links to ANVISA guidelines that pertain to the marketing authorisation of APIs, some of which had already been translated to English. Other ANVISA guidelines whose content is somewhat related to the marketing authorisation of APIs were also included, namely those that pertain to the marketing authorisation and post-approval changes of drug products.

The tab International Guidelines contains links to the main guidelines which are complementary to ANVISA’s own regulation. These guidelines were used as references in the construction of the Assessment Policy and will be considered in the revision of the API regulation.

The tab FAQ contains a list of frequently asked questions about a variety of topics. It is complementary to the assessment policy.

The tab Pharmacopoeias contains links to the most commonly used compendia, among those officially recognized by ANVISA.

The tab Others References contains both internal and external links whose content is related to the regulation of APIs.

The tab Summary of Changes contains the list of changes starting in version 5 (04/06/2018). Its purpose is to provide transparency and traceability to the changes of the website.

COIFA recommends applicants/API manufacturers to take the Assessment Policy into consideration in new submissions and responses to deficiency letters, as well as to clarify the main issues related to the marketing authorisation of APIs. Our intention is that the Assessment Policy be updated when necessary.

*We recommend the use of Google Chrome.