Masterarbeit

The regulatory approach to obtain marketing authorisation for locally acting cutaneous used medicinal products from a generic pharmaceutical company's point of view with a focus on quality of the products ***

Sylvia Haser (2017)

Summary
Language: English
The applicant of a generic product has to provide bioavailability studies to show bioequivalence. For locally acting products for cutaneous use this requirement could not be fulfilled as these products do not act systemically which is a prerequisite. Also, if the strict definition of a ‘generic medicinal product’ is not met a generic application is not possible. For this kind of product the so called ‘hybrid application’ should be used. The generic medicinal product according to a hybrid application refers to a reference medicinal product with a Marketing Authorisation in a Member State or in the Union. Complete administrative and quality data and appropriate preclinical and clinical data has to be provided for Marketing Authorisation application.
The efficacy of locally applied and locally acting medicinal products for cutaneous use depends as much on the API and its dosage as the composition and, biopharmaceutical properties of the vehicle. Each change in the constituents, amount or quality of them or the manufacturing process could have an influence on the release, penetration or metabolism.
This thesis makes an overview on considerations, which should be employed during development of locally acting cutaneous used generic medicinal products and for compiling the corresponding dossier (module 3).
The whole development of the product is crucial for the product performance, stability and clinical study.
A key element to be considered is the API and its general properties such as solubility, polymorphism or particle size.
Further key elements are the use of excipients, which may have great impact on the product behaviour as well as on the manufacturing process itself. These aspects can influence the physicochemial properties, which can have an effect on the performance, for example.
Increased attention must be paid on the container closure system in contrast to solid oral dosage forms for example. The mostly liquid properties promote interactions, which should be avoided to prevent negative influences on the finished product.
The requirements for an application of Marketing Authorisation for topical products are under development. The proof of equivalence has to be shown to the reference product and the generic product itself from clinical studies to the whole life-cycle.
Pages: 63, Annexes: pages : -