The European Medicines Agency (EMEA) has set a timetable for the implementation of electronic-only applications for marketing authorisation through the centralised approvals procedure.
Ultimately geared to establishing the Electronic Common Technical Document (eCTD) as the required format for electronic submissions, the implementation strategy is being pursued within the wider context of an EU initiative agreed by the Heads of Medicines Agencies in Reykjavic in February 2005.
This stipulated that, by an agreed deadline of the end of 2009, the European Regulatory Network must have the infrastructure and processes in place to handle electronic-only eCTDs in support of the related decision-making processes for medicinal products in the European Union.
The major milestones for the EMEA’s implementation strategy are:
– From 1 July 2008, the agency will accept electronic-only submissions for marketing approval, either in the recommended eCTD format or a non-eCTD format, with no additional requirement for paper copies.
This will apply to all applications, both new and existing, and to all types of submission to the EMEA through the centralised procedure (e.g., new applications, supplementary information, variations, renewals). It does not apply to veterinary medicines. Rapporteurs and members of the Committee for Medicinal Products for Human Use (CHMP) may, however, “still have some paper-copy requirements at this point”, the EMEA notes.
– As of 1 January 2009, the agency will “strongly recommend” electronic-only submissions, either in eCTD or non-eCTD format. Paper will be “an exception to the general e-format recommended for any application”. These conditions will affect all applications (new and existing) and all types of submission to the EMEA. Rapporteurs and CHMP members will no longer receive paper copies from this date.
– From 1 July 2009, the EMEA will “strongly recommend” electronic-only submissions in the eCTD format. Paper and other electronic formats will be treated as an exception to the general eCTD format recommended for any submission. This will affect all applications (new and existing) and all submission types. Rapporteurs and CHMP members will not receive paper copies or electronic formats other than eCTD from this date.
Until July 2008, the current guidance remains in force and electronic submissions in eCTD or non-eCTD format will continue to be accepted by the EMEA, rapporteurs and CHPM members, along with the specified number of paper copies.
The structure as well as the folder and file names in an eCTD correspond to those in the conventional Common Technical Document, which was developed by the International Conference on Harmonisation (ICH) as a standard format for regulatory submissions in the US, Europe and Japan. The specification for the eCTD was developed in parallel with the guideline for use of the Common Technical Document.
Extra components
While the eCTD is essentially just an electronic version of the Common Technical Document, it does include additional technical components that enable the lifecycle of individual files within the application, and the lifecycle of the product itself, to be managed, the EMEA notes.
The agency has been accepting electronic submissions alongside paper versions for some time. “While the electronic dossier is used for ease of management of information and review, the burden of processing the paper dossiers in tandem remains,” it comments. “There is also some variation in the presentation of electronic submissions received.”
Among the additional benefits of the eCTD format, the EMEA cites the ability to show the relationships between dossiers; the ability to see the current documentation for a product at any time; standardisation and harmonisation of the information provided; and harmonisation of the regulatory process.
Once the agency moves to eCTD applications as the preferred electronic format from 1 July 2009, any other types of electronic submission “may require different handling, and will not be subject to the same technical validation and comparative checks as eCTD submissions, which may in turn affect the quality and speed of the procedure and the feedback received”, it warns.
In terms of member state provision for the recommended format, all national competent authorities (NCAs) in the EU and the European Economic Area are capable of receiving and reviewing eCTD submissions, even if no dedicated eCTD review tool is in place at national level, the EMEA says, adding: “No European NCA should refuse an eCTD submission”.
