Medicines regulatory news
Amendment to article published 23 December 11
From 3 January 2012, the MRHA will be performing a technical validation of all new MAA eCTD submissions.
We will be using the Extedo EiY tool to carry out the validation and these submissions will be validated against the current EU- eCTD v3.1 validation criteria as published on the eSubmissions website (external link).
A report will be provided if there are deficiencies but, in the case of a valid submission, we will simply continue processing.
Applicants are reminded of the MHRA national requirements which require SmPCs to be submitted in the MHRA word template and for the provision of consolidated label and leaflets still apply. As these documents are specific to the UK they should be included in the working documents folder which is outside of the eCTD sequence folder.
For further guidance on making submissions in the eCTD format please see the CMDh Best Practice Guide (external link) on the use of eCTD in the MRP/DCP.
This validation procedure will not apply to NeeS applications or variations although it is likely that is will be expanded to include these applications in 2012.
RMS Technical Validation Pilot
From 1 March 2012, an RMS validation pilot scheme will be launched by EU Competent Authorities. Under the scheme, applicants will be able to send new MAA DCP eCTD applications to the RMS for an initial technical validation check. It’s envisaged that applicants will be either by provided with a valid report which is to be sent together with their dossiers to the Concerned Member States (CMS) or, if there is a deficiency, a report detailed the deficiencies. In the case of a failed validation, the applicant will be required to resubmit a corrected application to the RMS.
An RMS validation will be accepted by all CMS – it is not envisaged that CMS carry out their own independent eCTD validation. The MHRA intended to participate in this pilot and more information on the detailed process will be provided in due course.
Participation in this pilot will be voluntary for applicants.
For further information on technical validation on eCTD submissions please contact:
Submission Centre Team Lead