26.01.2012

UK MHRA details technical validation process for eCTDs

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has released some information regarding the technical validation of electronic Marketing Authorisation Application (MAA) dossiers submitted in eCTD format.

According to this information, the MHRA is using the EURSvalidator to validate incoming eCTDs against the EU eCTD validation criteria 3.1 that came into force in September last year (see our related News article). Applicants will receive a validation report only in case any deficiencies are identified during this technical eCTD validation. In case of valid submissions, the submission will be further processed according the corresponding application procedure. In that context, the MHRA reminds applicants of the UK national requirements to provide fragmented SPC files for each section of the SPC and to provide consolidated versions of the label(s) and leaflet(s). Such files should be provided within the "workingdocuments" area outside of the eCTD.

Furthermore, a pilot RMS validation scheme will start on March this year. This scheme foresees that applicants can voluntarily submit new eCTDs for MAA dossiers within EU DCP to the RMS which will be responsible for the central initial technical validation check. CMS will no longer carry out eCTD validation steps on their own. In case the submission is technically valid, the applicant will receive the eCTD validation report from the RMS which he then will distribute together with the eCTDs to the CMS. In case of deficiencies, these will be detailed in the report. In case of a technical invalid submission, the corrected eCTD must be resubmitted again to the RMS. The MRHA will take part in the pilot scheme and will provide further information in due course.

For more information, please be referred to the MHRA website (see link at the bottom of this article).

[Source: MHRA website]

Links:

www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON137941

<- Zurück zu: News