Just in time before the holidays in December 2024, the European Medicines Agency (EMA) gave us not just one but three updates. As you might need them to make your subsequent submissions shine, we have unwrapped and briefly summarized them here.
With this recently published guidance document, the EMA intends to assist pharmaceutical companies with the submission of regulatory information in electronic Common Technical Document format (eCTD) to the National Competent Authorities (NCAs) as well as to the EMA. It is aligned with the EU M1 eCTD Specification v3.1 and the Validation Criteria v8.1. NCAs can use this guidance to harmonize the requirements for eCTD submissions in EU/EEA. The several changes are in accordance with the EU M1 eCTD Specification 3.1.
The timelines for the optional and mandatory use are as follows:
You can access the complete document here, together with the Release notes.
2. EU eCTD v4.0 Controlled Vocabularies in .xml format available
The EMA published a package containing the first version of the eCTD v4.0 Controlled Vocabularies in genericode .xml format. They are complementing the MSExcel (.xlsx) version which was published in October.
3. eSubmissions Gateway: Naming of the Working Documents Folder
Regarding the eSubmissions Gateway, we learn more about the Working Documents Folder. It should always be called "xxxx-workingdocuments" and be provided on the same submission zip package
containing the eCTD. The number (xxxx) needs to match the number of the eCTD sequence being submitted. Any deviation will lead to a failed submission, meaning the package will have to be resubmitted with the correct naming, but the reason for the invalid submission is not clearly described in the message the applicant will receive.