Five Step Approach to Assess the Equivalency Requirements of Topical Products
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 a