EMA Guideline on Quality and Equivalence of Topical Products

The European Medicines Agency (EMA) has published a new guideline on the quality and equivalence of locally applied, locally acting cutaneous products.

Background

In October 2024, the EMA announced the adoption of the long-awaited guideline on the quality and equivalence of topical and locally acting skin products. The guideline, previously entitled “Draft Guideline on Quality and Equivalence of Topical Products”, was revised following a public consultation in 2019 and will enter into force in April 2025. The new guideline applies primarily to topical use. However, the principles may also be relevant for other medicinal products, such as products for use in the ear or eye (e.g. preparations for auricular or ocular use). Moreover, the scope of the guideline has been clarified to refer specifically to “topical and locally acting preparations” rather than the broader category of topical medicinal products. This change emphasizes the focus on preparations that act directly at the point of application as opposed to systemic absorption.

Quality Requirements & Equivalence Testing

The paper aims to rationalize and improve the regulatory framework for the quality and equivalence of topical products. Key points covered by the guideline include:

• Quality Requirements: Specific guidance is provided on the quality of dermatological products that are not comprehensively covered by existing pharmacopoeial guidelines or standards. 
• Equivalence Testing: Equivalence of topical preparations can be demonstrated without the need to conduct clinical trials to demonstrate therapeutic equivalence. This approach focuses on in vitro and pharmacokinetic methods, reducing the need for time-consuming and costly clinical trials.

The equivalence section is applicable to certain cases of therapeutic equivalence demonstration of a new medicinal product compared to an existing medicinal product. The guidance is applicable also to post-approval changes when potential impact on quality, safety or efficacy is expected based on the outcome of a risk assessment. Furthermore, "in the case of applications which rely on literature to demonstrate the safety and efficacy of the medicinal product, the relevance of the literature should be supported by equivalence bridging data to the product described in the literature".

However, the equivalence section does not apply:

• To biological medicinal products,
• To herbal medicinal products (HMPs),
• When equivalence with respect to efficacy is demonstrated by therapeutic equivalence clinical trials,
• When the pharmaceutical dosage form of the test and reference product are not the same.

More detailed information can be found in the full version of the guideline which can be found on the EMA Scientific guideline website.