Quality and equivalence of topical products - Scientific guideline

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.

Keywords: Medicinal products for cutaneous use, locally applied and locally acting medicinal products, skin permeation, in vitro release, stratum corneum (S.C.) sampling (tape stripping)

Current version

Draft guideline on quality and equivalence of topical products

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

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.

Document history

Draft guideline on quality and equivalence of topical products

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

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

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

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.