Facets of User-Friendliness: From Format to Content in Regulatory Submissions

Abstract

User-friendliness is one of those terms that take on different meanings when used by different people. Even from the point of view of a single group of users, for example, regulatory agency assessors, there are many facets to be looked at.

The public, on the one hand, expects rapid, but also thorough, cautious, and reliable assessment and registration procedures from regulatory agencies in order to ensure its fast access to new, safe, and effective medicines. The pharmaceutical industry, on the other hand, expects rapid, reliable, and unbureaucratic assessment and registration procedures from regulatory agencies in order to gain fast access to the markets for their products. To ensure an optimal outcome of the regulatory process several components have to be taken care of by the submitter, which can be summarized under the terms of “user-friendliness, “ or alternatively “ease of use. “

The ease with which an evaluation can be performed is first dependent on the format. The introduction of the future Common Technical Document will certainly lead to a major improvement over the present situation. Second, the material, scientific content of the dossier has to be presented in a logical and convincing way, making it easy for the assessor to follow the reasonings in the development of the various quality, safety, and efficacy issues and the conclusions drawn therefrom. Third, the dossier should be carefully controlled for its formal quality, that is, for clarity of print and pictures, for completeness of copies, for clarity and intelligibility of the language, and so forth. In this context, it must be remembered that, although it can be assumed that most assessors worldwide understand the English language, in most cases this will be only their second language, leaving them vulnerable to slips of spelling, grammar, or other linguistic or textual errors that will hamper the easy understanding and readability of the text, and user-friendliness must, therefore, also be seen under the aspect of possible problems of language barriers.