Draft guideline on quality and equivalence of topical products – still stuck? [Regulatives / Guidelines]

posted by mittyri – Russia, 2024-09-14 22:24 (53 d 10:24 ago) – Posting: # 24199
Views: 1,058

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?


  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.

Kind regards,
Mittyri

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