MHRA technical validation of marketing authorisation applications (MAAs)

From January 2012 there is a requirement on all EU member states acting as Reference Member State (RMS) for new MA applications to perform a technical validation of eCTD submissions. This RMS validation will also be accepted by all Concerned Member States (CMS) – it is not envisaged that CMS carry out their own independent eCTD validation.

To comply with this requirement, from 3 January, the MHRA will be technically validating all new MAA eCTD submissions for both National procedures and where the UK is RMS.

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.

For RMS procedures, applicants will be either 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.  We expect to provide these reports within 7 days of submission and they will be sent by email to the applicant.

For National submissions, a report will be provided if there are deficiencies but, in the case of a valid submission, we will simply continue processing.

The MHRA will not perform technical validation on the CMS submissions and will only upload these submissions if they are accompanied by a Technical Validation report from the RMS.

Applicants are reminded of the MHRA national requirements for SPC being submitted in the MHRA word template and for 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 on the use of eCTD in the MRP/DCP.

To find more information please click here

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

FDA: Updated PDF Specification (Version 3.0) Guidance Document

FDA has officially released the Updated PDF Specification document (version3.0) on 20^th December 2011.

In this document FDA has mentioned the applicant can use PDF Version 1.7 for documents however the applicant still submit their documents in version 1.4 – 1.7. Submitted PDF files should be readable by Adobe Acrobat 8.0.

The following key points FDA has updated in the updated PDF Specification version 3.0 document.

Special Consideration for Promotional Materials - Promotional materials submitted in PDF format may need special consideration to ensure that the accurate representation of the actual image. For photographs, the image should be obtained with a resolution of at least 600 dpi. Promotional material should be submitted according to its actual size when practical. When an image size is altered, the original dimensions must be stated. Images of three-dimensional promotional pieces must show all sides

and components.

Optimize the PDF for fast web view - While creating files from source documents use the “Optimize the PDF for fast web view” option to reduce file sizes and file opening times.

The “purpose of the document” section has been added in the document, FDA has revised some of the standard Fonts and gave more clarification about the security and usability PDF documents. 

 

To find the document please click here

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163565.pdf

Marr Consultancy : Update on EVMPD – End of year report

Since 1 September 2011 EMA has not communicated anything publicly on EVMPD in writing.  It has hosted an Information Day and is now conducting training – but you had to be there to hear what they had to say.  We don’t expect any communications now until mid-January at the earliest and so in a spirit of openness – and because I had some time in the run-up to year end – I have drawn together what I know and have experienced about :

• The status of the EVMPD programme
• The documentation that is outstanding
• The EV Web Tool and EVMPD training
• Questions and Answers that I know about (I’m sure that there are more that I don’t and hopefully people will share these as well)
• The vendor and service provider market

To find more information Please click here - Marr Consultancy : Update on EVMPD – End of year report
 

Marr Consultancy

Seasons Greetings and a Happy New Year to all from eCTD Regulatory Submissions Network Group & Blog!!!!

Dear All, As we are moving into the holiday seasons, I would like to wish all of you a Happy Christmas and a Happy New year 2012.

As the New Year is about to blossom, I wish you all to have a great time ahead.  May this New Year 2012 will be wonderful year. 

I take this opportunity to thank all of your participation and support for this group and blog. 

 

Kind Regards

Shakul Hameed