Bioequivalence and Bioavailability Forum

Dear All!

may be someone can shed some light on the current status of guideline on quality and equivalence of topical products in EMA jurisdiction¹?
The consultation period is over more than 5 years ago and no updates on EMA site so far.
Citing a paper with experts²:

❝ The principles defined in the EMA draft guideline on the quality and equivalence of topical products reflects the current state-of-the-art methods and are similar to those of the US-FDA. These principles have been applied in recent years and some products have been approved, which demonstrates that it is applicable; however, it could be convenient to widen the acceptance range according to the observed variability in the reference product.

Everything is good to go, little amendments required. So what?

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1. CHMP/QWP/708282/2018. Draft guideline on quality and equivalence of topical products.
   
2. García-Arieta A. et al. Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union. Pharmaceutics. 2023; 15: 601. doi:10.3390/pharmaceutics15020601.