Quality and equivalence of topical products
The guideline relates to locally applied and locally acting medicinal products for cutaneous use and is also relevant for other medicines e.g. preparations for auricular or ocular use. Specific guidance is provided:
On the quality of topical products not covered by other guidelines.
On equivalence testing of topical products in lieu of therapeutic equivalence clinical trials.
As common knowledge in the field is currently being built, the draft guideline is published for public consultation to stimulate discussion. Comprehensive feedback would be welcome and as a result further elaboration of the equivalence guidance should be expected. In the meantime requests for scientific advice on specific recommendations or on clinical development are strongly encouraged.
Draft guideline on quality and equivalence of topical products (PDF/256.86 KB)Draft: consultation closed
First published: 14/12/2018
Consultation dates: 14/12/2018 to 30/06/2019
Concept paper on the development of a guideline on quality and equivalence of topical products (PDF/93.46 KB)Draft: consultation closed
First published: 22/04/2015
Last updated: 22/04/2015
Consultation dates: 22/04/2015 to 22/07/2015