Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Between Standardisation and Flexibility - Defining Granularity of the eCTD Module 3.2.S for Different Types of Drug Substances in Europe ***

Wolfgang Gulbins (Abschlußjahr: 2016)

Summary
Language: English
There are numerous and very heterogeneous drug substances on the market or still in development and requirements on information in the MA dossier about their quality varies widely. Nevertheless, the CTD aims to provide a structure for organising the content of the MA dossier that is suitable for every drug product.
The Granularity Document and the eCTD specification attempt to define a granularity as rigid as needed for standardised presentation of information and as flexible as possible for adaption to the respective substance’s needs, but always applicable for both initial MAA and lifecycle submissions. Nevertheless, the degree of suitability of Module 3.2.S structure varies widely for different types of drug substances.
The eCTD granularity and its basic option to either submit one or multiple documents under the respective heading largely works well for NCEs and, with some limitations, ASMFs. For well-known substances needing only little information in Module 3.2.S, which could easily be presented in just a single document, an option to roll-up the content under some headings would be preferred. In contrast, for complex Biotech products, a high volume of data is required, for which in some sections deeper CTD levels and eCTD attributes would be desirable.
Lifecycle issues primarily evolving from changes to manufacture(r) can get quite annoying due to strict one-to-one exchange of documents and the impossibility to adapt eCTD attributes. Strategic dossier planning and some workarounds could limit such issues; however, unexpected scenarios might occur anytime.
The recent revision of the Granularity Document does not solve the most urgent issues. Admittedly, most issues are inherent to the eCTD v3.2.2 specification and can only be addressed with a revision of the specification itself. Nevertheless, some more flexibility like, e.g., rolling-up documents to higher eCTD levels was to be expected.
Overall, current eCTD specification v3.2.2 and the revised Granularity Document are a reasonable compromise and provide a solid structure to start with building a MA dossier for the majority of drug substances. This sure is one of the reasons for the wide acceptance and ever-increasing use of eCTD.
The advance of eCTD v4.0 and the recently published implementation documents promise solutions for the remaining issues by offering more flexibility of granularity and new concepts for improved lifecycle management.
eCTD v4.0 has the potential to finally succeed in offering both – Standardisation AND Flexibility.
Pages: 49