EMA Guideline: Quality and Equivalence of Locally Applied, Locally Acting Cutaneous Products

The European Medicines Agency (EMA) recently updated the guideline on "Quality and Equivalence of Locally Applied, Locally Acting Cutaneous Products" which provides a comprehensive guideline on the quality and equivalence of locally applied, locally acting cutaneous products, which are used directly on the skin. This document is essential for ensuring that such products meet consistent standards of safety, efficacy, and quality, especially when comparing generic or similar products to the innovator or reference products.

This guideline pertains to local applications and local-acting medicines for cutaneous use, but may also apply to other medications e.g., preparations for auricular or ocular use, and locally-acting vaginal products. Specific guidance is provided: 

• on the quality of cutaneous products not covered by other guidelines or the relevant Pharmacopoeia standards; 

• on equivalence testing of cutaneous products instead of therapeutic equivalence studies with clinical endpoints.

Guidance is provided on other models and studies that may be used to determine equivalence concerning

1. quality,

2. efficacy

3. safety that taken together support a claim of therapeutic equivalence, when the method of administration is the same.

There are currently guidelines that indicate that changes in formulation, dosage form, administration method, or manufacturing process can significantly impact the efficacy and/or safety of topical products. In principle, therapeutic equivalence studies with clinical endpoints are necessary, but alternative models can also be used or developed. This guideline provides further details on the use of in vitro and in vivo models in a step-by-step manner to establish therapeutic equivalence.

The guideline  emphasizes the importance of detailed pharmaceutical development, which includes ensuring the appropriate formulation and manufacturing processes. Factors such as particle size, viscosity, and spreadability of the product can affect its performance on the skin, and these must be controlled and justified during product development.

For further details, refer to the full guidelines on the EMA website or download the complete document here.