Concept paper on the development of a guideline on quality and equivalence of topical products

In recent years, the assessment of topical products has evolved. It has become evident that their quality needs to be thoroughly understood and characterised, supported by a robust manufacturing process and control strategy. In addition, the designated shelf life needs to be based not only on physical, chemical and microbiological stability, but also, when necessary, on evidence of stable in vitro performance to assure equivalence throughout storage.

Reference number: EMA/CHMP/QWP/558185/2014

Status. draft: consultation open

First published: 22/04/2015

Last updated: 22/04/2015

Consultation start date: 22/04/2015

Consultation end date: 22/07/2015

See the document