Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

eCTD submissions - a global reality already? ***

Dr. Henrietta Dehmlow (Abschlußjahr: 2016)

Summary
In order to apply for a market authorization of a new drug or to file a variation for an approved medicinal product, a dossier has to be compiled and submitted to the national competent authority. The structure and the content of those dossiers has been harmonized by the International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in the year 2000. The ICH Common Technical Document (CTD) structure was adopted in the following years, and specifications for an electronic standard, the eCTD submission format, has been released in 2002. The original standard was updated in the following years. The current version is eCTD v3.2.2. In recent years that standard has not only been accepted in the ICH founding member states, but has gained further acceptance. This work looks at the current worldwide implementation status of eCTD submissions, and the future measures taken in some regions/countries to further advance its acceptance. Although the eCTD format has been established more than a decade ago, still it is not used for all of the submissions in the ICH founding member states, but clearer roadmaps towards a higher level of implementation have been established now. More of the other countries are moving to this standard as well, and although it is far from a globally accepted submission type, it is already globally far spread. In the upcoming years, a further progression towards making eCTD submissions a global reality will be seen. The transition towards it has picked up momentum with more countries piloting it, and setting the arena for other countries in their region (e.g., Australia, Thailand, Saudi Arabia, South Africa).
Analysing the implemented local standards, revealed that although a standard format has been set, the regional implementation is different for submission types. In addition to the regional module 1, the handling of the submission life cycle can be different between countries/regions. This has to be taken into account when handling eCTD submissions globally. A further harmonization could lead to a further enhancement in the submission management of dossiers on a global level. In most countries and regions in which this format is used, it is applied for marketing authorization applications as well as for the related variations; however, for investigational drug dossiers it is so far only accepted in the US. This could be a topic for future implementation in other regions, as it could eventually reduce the number of additional submissions and could facilitate the global handling and review of dossiers. It could thus lead to shortened time frames for dossier preparation and review. The same benefits identified for marketing authorizations could apply for those dossiers.
As an additional outlook, information on the next version of eCTD, namely eCTD v4.0 is presented. This new version will introduce the regulated product submission (RPS) standard, and will thus address some of the current pain points such as changing the granularity and referencing across applications. It also will provide additional benefits like consistent vocabulary, grouping of documents and capturing two way communication. The expectations for this new release are high and will hopefully enhance the global acceptance of eCTD further.
Number of pages: 70, Annexes 11 (pages 20)