Five Step Approach to Assess the Equivalency Requirements of Topical Products

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The changes are sometimes unavoidable part of life, but in the regulatory world, every change needs a justification. 
The change which looks smaller can be linked to the safety and efficacy of the final product whether it is a large or small molecule. Moreover, the changes in topicals are more critical than conventional routes, as any change for e.g. changes in API, excipients, manufacturing processes, equipment, packaging etc. may significantly influence the quality of the product with respect to rheological properties, microstructure/physical properties, and stability behaviour.
These quality differences are typically not predictable and may have an impact on the bioavailability of topical products. Keeping this in mind Last year, EMA has released a draft guideline on quality and the equivalence of topical products. How you should approach your topical product to make it compliant with regulatory requirements? I would like to brief a simple and generic 5 step approach in this article.
Five steps approaches

1. Classify your product 
First of all determine the category of your product: Whether it is a simple or a complex formulation?  
2. Assess the change
Make sure none of these below quality attributes are changing. Changing these attributes means quality assessment will not be enough and safety and efficacy equivalency may be needed. This should be determined case by case.

3. Perform a risk assessment
Is quality equivalency enough or we should perform safety and efficacy studies? The answer depends on the following factors:
  • Knowledge about API and excipients- Is it known API and excipient?
  • Mechanism of action- Local vs Systemic topical effect?
  • Therapeutic index of drug – Narrow vs wide therapeutic index?
  • Extent of changes – Is this a major change, which can impact the properties of the final product?
4. Determine the product specific equivalency testing
 The detailed studies required for equivalency with respect to quality, safety and efficacy: 
5. Conclusion
In summary, to follow appropriate equivalency approach, following generic conditions to be considered:
I hope this article will provide you an structural approach for equivalency assessment of topical product. Happy Learning!

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