Quality and equivalence of locally applied, locally acting cutaneous products - Scientific guideline

The guideline relates to locally applied and locally acting medicinal products for cutaneous use but may be also relevant for other medicines e.g., preparations for auricular or ocular use, and locally acting vaginal products.

In this guideline specific guidance is provided on: 

• the quality of cutaneous products not covered by other guidelines or the relevant Pharmacopoeia standards; 
• equivalence testing of cutaneous products in lieu of therapeutic equivalence studies with clinical endpoints.

Keywords: Medicinal products for cutaneous use, topical products, locally applied locally acting medicinal products, skin permeation, in vitro release, stratum corneum sampling, tape stripping. 

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Note: following the revision of the draft document after the public comments the title of the Guideline has changed to 'Guideline on quality and equivalence of locally applied, locally acting cutaneous products' to more accurately reflect the products concerned by the guideline.

Current version

Guideline on quality and equivalence of locally applied, locally acting cutaneous products

Adopted Consultation dates: 14/12/2018 to 30/06/2019 Reference Number: EMA/CHMP/QWP/708282/2018

Document history

Overview of comments received on 'Draft guideline on quality and equivalence of topical products' (EMA/CHMP/QWP/708282/2018)

Reference Number: EMA/CHMP/QWP/451535/2024

Draft guideline on quality and equivalence of topical products

Draft: consultation closed Consultation dates: 14/12/2018 to 30/06/2019 Reference Number: CHMP/QWP/708282/2018 Summary:

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.

Note

The equivalence guidance is applicable to certain cases of demonstration of equivalence of a new topical medicinal product with an existing medicinal product.

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.

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

Draft: consultation closed Consultation dates: 22/04/2015 to 22/07/2015 Reference Number: EMA/CHMP/QWP/558185/2014 Summary:

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.