Carla M. Caramella, Department of Drug Sciences – University of Pavia-I, Pavia, Italy

The concept of significant therapeutic innovation, is acknowledged by EMA in defining eligibility criteria for centralized procedures. This criterion includes changes in pharmaceutical form and route of administration (as a legal basis for Marketing Application).In the Italian regulatory scenario, technological innovation (including innovative formulations) are considered as potential therapeutic innovation.
The perception of innovation of formulation scientists is somewhat more elaborated: novel dosage forms (technologies) for controlled drug release are those intended to optimize drug release, in terms of extent, rate and/or site of delivery, with the aim of obtaining a therapeutic improvement (in terms of efficacy, safety, even compliance) and /or eventually social and/or economic advantages.
Formulation scientists are much interested in the general principles that govern the quality assessment of their intended innovative medicinal products on behalf of registration bodies. Even though no specific quality guidelines apply in the case of innovative technologies or dosage forms, in the general guidelines there are some passages that specifically address specialized/innovative pharmaceutical forms, which should be strictly followed by the applicant to give assurance that the pharmaceutical development has been properly managed, the manufacturing process is under control and that the control strategy is appropriate.
The aim of the presentation is to give some examples of development of novel/innovative technologies/dosage forms for controlled drug delivery and to illustrate the main requirements/challenges that are encountered in getting the Marketing authorization.