On 1 October 2024, the European Medicines Agency (EMA) announced the adoption of the long-awaited “Guideline on Quality and Equivalence of Locally Applied, Locally Acting Cutaneous Products” (EMA/CHMP/QWP/708282/2018) by the Committee for Medicinal Products for Human Use (CHMP). The guideline, previously titled “Draft Guideline on Quality and Equivalence of Topical Products,” has undergone revisions after public consultation and will come into effect on 2 April 2025.
Key points addressed in the guideline include:
- Quality Requirements: The guideline offers specific guidance on the quality of cutaneous products that are not comprehensively covered by existing guidelines or Pharmacopoeia standards. This ensures a harmonized approach to product quality across the European Union.
- Equivalence Testing: The document outlines how companies can demonstrate the equivalence of topical products without relying on clinical therapeutic equivalence studies, which are traditionally required. This approach focuses on in vitro and pharmacokinetic methods, reducing the need for time-consuming and costly clinical endpoint studies.The scope of the guideline has been clarified to specifically address “locally applied, locally acting cutaneous products” rather than the broader category of topical medications. This change underscores the EMA’s focus on products designed to act directly at the site of application, as opposed to systemic absorption.
The adoption of this guideline marks a significant step forward in the regulation of topical products, offering clearer direction for manufacturers and ensuring that patients across Europe have access to safe, high-quality treatments.
For more detailed information, you can access the full guideline here.
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