Common Technical Document Erfahrungen und Ausblicke fünf Jahre nach Implementierung Dr. Christa Schröder1, Dr. Rainer Canenbley2 und Otmar Pfaff3 Paul-Ehrlich-Institut1, Langen, Yes Pharmaceutical Development Services GmbH2, Friedrichsdorf, und Merck KGaA3, Darmstadt The purpose of the following article is to present the experiences of the last five years on working with the Common Technical Document (CTD), which since 2003 has been implemented in Europe in accordance with relevant ICH stipulations (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, http://www.ich.org). One ICH objective is to harmonise the criteria for assessing applications for marketing authorisation of pharmaceuticals in the European Union, USA and Japan. For that purpose, ICH has developed apropriate guidelines for these regions.
The CTD is mandatory in these three regions for most marketing authorisation applications. In the meantime, it has also been adopted by countries such as Canada and Switzerland. This means that documents needed for marketing authorisation of new pharmaceutical products can generally be submitted in a common format. While considerable headway has been made on the road to harmonisation, alongside variations in content, there are also some variations in format that require harmonisation, e. g. the regional differences between the various CTD modules.
The CTD is divided into four modules covering the areas Quality (Modules 3 and 2.3), Non-clinical (preclinical) data (Modules 4, 2.4 and 2.6) and Clinical data (Modules 5, 2.5 and 2.7).
Since each country has its own legal definitions and requirements, languages and other differences, it was agreed not to harmonise Module 1 at ICH level but to leave it under regional regulation.
The following article examines whether implementation of the CTD has proved a boon or a burden. The discussion focuses on the following topics: applications for new marketing authorisations, lifecycle management, transparency, working with the modules; has the CTD generated added value? What could we do better?
In the last chapter, it is suggested that the properties of the advanced therapy medicinal products call for revision of the CTD format. As well as posing great challenges (e. g. presenting processes that are individualised for each patient in a dossier), revision would also enable the CTD to be amended according to ongoing experience, or, for example, to optimise company internal processes.
There are also other product groups for which similar definitions in all three ICH regions would also benefit their global development and enable one CTD to be written. Why not start discussions on this topic in Europe on the premise of the Lisbon Agenda set out in 2000? |
