CMDh: Technical validation of eCTD submissions for new MAAs in DCP - Start of pilot phase (voluntary)

The CMDh has agreed on a pilot phase for technical validation to be performed by the RMS on behalf of all CMSs, starting 1 March 2012, for eCTD submissions for new Marketing Authorisation applications in DCP (excluding extension applications). The pilot phase will be run for one year and followed up continuously (see contact details below) by the end of the pilot an evaluation will be made to decide on future handling. Applicants are therefore encouraged to submit applications within this pilot workflow so that it can be truly tested and evaluated. Following a positive evaluation of the pilot phase it is envisaged to extend the pilot to include also other submission types like variations and renewals as well as submissions in NeeS-format. 

To find more information please use the below mentioned weblink

CMDh: Technical validation of eCTD submissions for new MAAs in DCP

- Start of pilot phase (voluntary)

The CMDh Meeting: eSubmissions Update for Technical Validation

The pilot phase for technical validation to be performed by the RMS on behalf of all CMSs, starting 1^st  March 2012, for e-CTD submissions for new Marketing Authorisation applications in DCP (excluding extension applications).

Applicants willing to participate to the pilot are invited to submit their applications according to the instructions given in the document called “Technical validation of e-CTD submissions for new MAAs in DCP – start of pilot phase” that will be published on the CMDh website under “Procedural Guidance, eSubmissions

To find more information please click here

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/cmdh_pressreleases/2012_02.pdf

EMA: Pre-authorization procedural advice for users of the centralized procedure (Question & Answers Document)

This document addresses a number of questions which users of the centralised procedure may have. It provides an overview of the European Medicines Agency’s position on issues, which are typically addressed during the course of pre-submission meetings.

This guidance information and fruitful pre-submission meetings should enable applicants to submit applications, which are in conformity with the legal and regulatory requirements and which can be validated speedily. Pre-submission meetings will also enable applicants to establish contact with the EMA staff closely involved with the application as it proceeds.

Questions and answers are being updated continuously in this document, and will be marked by “NEW” or “Rev.” with the relevant date upon publication. 

To find the document please use the below mentioned EMA weblink

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004069.pdf

ELC Group launches new software subsidiary Pharma eReport to provide complete EVMPD compliance solution

ELC Group, the pan-European pharmaceutical regulatory affairs organisation, today announces the launch of a new subsidiary, Pharma eReport – a software and services company that delivers a comprehensive EVMPD compliance solution for pharmaceutical regulatory professionals.

Pharma eReport offers a total package for Marketing Authorisation Holders (MAHs) seeking to meet the July 2nd 2012 deadline for mandatory EudraVigilance Medicinal Product Dictionary (EVMPD/XEVMPD) data submissions. With its flagship Centrality software suite and specialist EVMPD services – delivered by a Key Support Services team of qualified chemists – Pharma eReport provides a comprehensive EVMPD solution, including complete outsourced data-gathering and compilation of Structured Substance Information (SSI) libraries. The Centrality software is available as an on-demand software-as-a-service (SaaS)/cloud-based solution – accessed via a standard web browser – or it can be installed as a standalone software application. Centrality is offered via a transparent pricing model and will be in full general availability from March 2012. Prospective users are invited to sign up online now for priority product demonstrations.

Pharma eReport’s Centrality software tool allows MAHs to quickly and effortlessly convert existing medicinal product information into an XML Schema Definition (XSD)- compliant format, and seamlessly upload the required data as a EudraVigilance Product Report Message (EVPRM) using an approved submission mechanism. The software is secure, easy to use and custom-engineered for flexible implementation, including development support for bespoke interfaces to provide full harmonisation with customers’ existing systems.  

To find more information please click here

http://www.neondrum.com/public/public_release.php?id=1115#

FDA News Alert: Notable Progress’ in FDA Reception of Marketing e-Submissions

FDA’s ongoing transition to universal (and, ultimately, mandatory) acceptance of regulatory submissions for advertising/promotional submissions in electronic format, although the process is currently more advanced for submissions related to biologic products than for drugs. Details concerning the status of the agency’s electronic submissions initiative were discussed at the 2012 Marketing Conference sponsored by the Drug Information Association (DIA) 2/1.

According to CDER Office of Prescription Drug Promotion associate director Marci Kiester, the process of transitioning to electronic submissions for regulatory materials may be said to have begun in 2008, with FDA’s acceptance of the electronic Common Technical Document (eCTD) — an ICH standard for regulatory submissions now recognized not only by FDA but by counterpart Canadian, Japanese, Swiss, and European regulatory authorities. Kiester noted that Module 1 of the eCTD pertaining to advertising/promotional submissions has recently undergone some modification in order to make it more user-friendly for sponsors, and more useful to agency reviewers. Specifically, these changes include additional sub-headings to elements of the document, affording more “granularity” to the information provided and, further, allowing submissions to be amended or updated more easily. With modification of Module 1, supportive files will no longer reside in the eCDT folder, but will be referenced at a Web location, Kiester said.

Although the agency components responsible for reviewing advertising/promotional materials are currently receiving electronic submissions, paper submissions remain acceptable and, indeed, still constitute the majority of submissions. A 10/26/11 Federal Register notice solicited comments on the architecture/specifications of the revised Module 1 draft, and a total of more than 200 comments were received. Kiester indicated the agency is now reviewing these comments prior to a planned 9/18/12 public meeting at which the module will be discussed with stakeholders. She said a time-frame for full implementation of the electronic submission initiative has not been determined, though she “hopes it might be possible early in 2013.”

 

To find more information please use the below mentioned FDA webpage

http://www.fdanewsalert.com/212115.html