ANVISA published the second version of Guideline 20/2019, which provides guidance on quality requirements for topical and transdermal products.

This guideline was published in 2018 and it was open for contributions for one year, resulting the new version published on ANVISA’s website. The current version improved some textual topics in this document and its scope is no longer restricted to Marketing Authorization, extending also to the entire product life cycle.

Regarding to quality aspects, we can highlight the following topics:

Inclusion of the available dose uniformity test, as well as the concept of non-applicability for the uniformity test in the packaging material for fluid topical products that need to be stirred before use.

Complement of the requirements for receiving medium used in performance tests and membrane used in permeation tests.

Access the complete Guideline throught the link: https://bit.ly/3pR15dA