Hotfix for BfArM eValidator (Software for technical validation of e-submissions)

The folder name check for EU m1-3-1-spc-label-pl reported false negatives due to an error in the configuration (the language folder is missing in the software configuration). The hotfix corrects this error. For NeeS, the Module TOC check reported false negatives for absent modules. The hotfix corrects this error. The style sheet reference check did not handle all valid syntax options properly. Hence, false negatives might have been reported. The hotfix corrects this error. The new rule for EU submissions "Sequence number not already used" did not work properly and reported false negatives. In M4, the new EU criteria do not allow additional subfolders at the study report level. The ICH specification however recommends using such folders for submissions with multiple files per study. Due to the new strict folder name check applied to most of the profiles, the 3.1 SP1 release reported all such subfolders in M4 as invalid. The hotfix corrects this error, i.e. the additional subfolders are now considered as valid, except for the new EU profile (which will be mandatory as of 1 September 2011).

For more information and download the validator please click: BfArM e-Validator

FDA: Updated ANDA Filing Checklist (CTD & eCTD Format)

FDA posts new ANDA FILING CHECKLIST (CTD or eCTD FORMAT) FOR COMPLETENESS AND ACCEPTABILITY of an APPLICATION

For More Information Please click: FDA ANDA Checklist

Introduction to the EU telematics programme

The Management Board Telematics Committee, at its meeting in February 2010, requested that a briefing document be prepared that might be styled 'Introduction to EU Telematics Programme'. The objective of this document is to explain the high level business needs being addressed by the EU Telematics programme, to describe each of the main systems and the basis for inclusion in the work programme and also to outline how the main systems interact with each other. This document also outlines the business mechanisms in place to manage the development and implementation of the various projects.

For More Information Please Click: EU Telematics Programme

Exalon: CMDh postpones deadline for the optional "parallel national model" for eCTD submissions in MRP/DCP

The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has announced in the CMDh meeting report from May 2011 that the deadline for using the optional "parallel national model" in MRP/DCP eCTD submissions will be postponed to the end of the year.

Until then, applicants may still consider the "parallel national model" (see CMDh/084/2008/Rev2; Best Practice Guide on the use of the eCTD in MRP/DCP) as an option for MRP/DCP eCTD submissions. In an earlier communication from February this year, the CMDh has initially declared a deadline of 1st June 2011 for the "parallel national model" (see our previous News article). However, postponing the deadline will allow for the development of further guidance to applicants.

For More Information Please Click: Exalon eCTD submissions in MRP/DCP

LORENZ eValidator addresses New International Validation Criteria

Frankfurt/Main, May 26, 2011 – LORENZ eValidator now addresses the new validation criteria sets the US and EU authorities are currently updating and which will be in effect from June 1 (US) and September 1 (EU).

LORENZ eValidator includes additions to the tree of backbones and regionals. Reports now also include information on the full path of the validated submission, the name of the user who started the submission, a profile description text and checksums of index files. Summary report and header section have been re-designed for improved legibility on high resolution screens. New features include changed options for PDF validation and an exception list for PDF file protection checks.
"As the eValidator supports changing criteria right from the start, we believe that yet again we provide our customers with a powerful, up to date tool," says Wolfgang Witzel, President of LORENZ Life Sciences Group.

For More Information Please Click: LORENZ eValidator New International Validation Criteria

NextDocs and Microsoft Jointly Present at the 3rd Annual Summit on Clinical Trails Investigator Portals

KING OF PRUSSIA, Pa.--(EON: Enhanced Online News)--NextDocs Corporation (www.nextdocs.com) the global leader in Microsoft SharePoint based software solutions for Life Science industries, today announced that NextDocs and Microsoft will be jointly presenting at the 3rd Annual Summit on Clinical Trials Investigator Portals which is being held in Philadelphia, PA on May 19-20.

Chet Shemanski, Director of Product Development at NextDocs will be joined by Michael Naimoli, Worldwide Managing Director Microsoft Life Sciences, in a presentation that outlines the seven elements of a SharePoint-based clinical collaboration platform. This platform provides an environment where diverse constituents can participate in the creation and management of clinical trial documentation in real time. The presentation is titled "SharePoint as a Clinical Collaboration Platform – The Seven Essential Functions" and will be presented on May 19th at 3 PM.

For More Information Please click: nextdocs Annual Summit on Clinical Trails Investigator Portals

Making PDF Part of Your Records Management Strategy

Will your documents be here tomorrow? If they are, will you be able to access them? Chances are the software systems used to create them will cease to exist in the coming years. What plan do you have in place to ensure your archives are readable in the future?



From former users of VHS tapes and zip disks, to those whose files were created in older versions of Word, WordPerfect or Lotus, all have a story about how they can no longer read or search through their digital media because the device or software needed to display or print the files no longer exists. What about today’s digital media? Will it too become unreadable along with the increasing volumes of traditional media documents (paper, microfilm and microfiche) that need to be searched and distributed across global networks with their digital counterparts?



Organizations faced with growing collections of electronic and non-electronic documents will need to manage, preserve, and make them searchable and available both now and in the future. The question is how. One answer is to convert all documents, both paper and digital, into a format that supports long-term preservation—one that preserves
documents electronically so they always display as exact replicas of their originals. Hence, a viable preservation format must not only be device-independent but also self-contained and self-documenting, with no access restrictions (like encryption).

For More Information Please Click: PDF and Records Management Strategy

Health Canada : Increased Scope of Submissions being accepted in Electronic Common Technical Document (eCTD) electronic-only filing format

Health Canada is pleased to announce an increase in the types of submissions being accepted in the electronic-only filing format for a subset of eCTD submissions.

The measures outlined in this Notice are effective immediately since they do not impose an obligation but rather provide more options for submission sponsors. Sponsors are encouraged to compile submissions using the most recent Guidance Documents and Notices.

This Notice is meant to be read in conjunction with the Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format. The guidance will be changed to reflect this Notice at a future date.

For More Information Please Click: Health Canada eCTD Updates

Article: From Go-Karts to Formula 1: Distinguishing True Digital Signatures particularly for the electronic submission of critical regulatory documents

Digital signatures have become an essential part of doing business in the drug industry, particularly for the electronic submission of critical regulatory documents. And yet many in the industry still do not know what constitutes a safe and compliant digital signature, much less know what separates digital signatures from “electronic” signatures, says Mollie Shields-Uehling, president and CEO of the standard-setting SAFE-BioPharma Association.

The SAFE-BioPharma standard is used to verify and manage digital identities involved in electronic transactions and to apply digital signatures to electronic documents, Shields-Uehling says. The standard was developed by a non-profit consortium of biopharmaceutical and related companies, with participation from the FDA and EMA. “The SAFE-BioPharma digital signature offers a greater level of protection than other forms of electronic signature,” she adds. “It provides authentication, non-repudiation and data integrity across every single bit of the information to which the signature is applied. In simple terms, this means that if any component of the signed document is ever changed, the signature will be invalidated.

For More Information Please click: eSubmission and eSignature

A RAPS interactive workshop: Preparing Compliant eCTD Submissions-18 to 19 July 2011

Preparing Compliant eCTD Submissions

A RAPS interactive workshop!

Hyatt Regency Long Beach
Long Beach, CA
18–19 July 2011

Roll up your sleeves for a two-day unbiased introductory workshop comprised of skill building, interactive exercises, case studies and small group discussions to learn how to prepare an effective electronic Common Technical Document (eCTD) submission on any platform.

Every regulatory professional should know the standards, groundwork, expertise and technology required to submit an electronic submission within the US and globally. Due to its cost effectiveness, and because it guarantees a faster response from the recipient regulatory agency, reducing time-to-market, the eCTD has become the standard for numerous regulatory agencies around the world.

For More Information Please Click: RAPS eCTD Workshop

CMDh BEST PRACTICE GUIDE FOR eCTD IN THE MRP AND DCP PROCEDURES

This best practice guidance has been developed in order to facilitate the use of the eCTD as a submission format in the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP). The guidance shows the way for an applicant to meet their legal obligations within MRP and DCP in eCTD format. Some general principles apply to both procedures but there are some differences between the details for the MRP and DCP.

For More Information Please click: CMDh eCTD Best Practice Guidance for MRP and DCP

Latvia National Agency for Medicines updates the eSubmission Requirements

Procedure for submission of electronic documents

Latvia National Agency please be informed that the future of electronic documentation for medicine registration, renewal and change, State Agency of Medicines will also be submitted by e - mail, signed with secure electronic signatures and CD and DVD discs.

Electronic documents for medicine registration, renewal and changes submitted through the following electronic media:

Option No. 1

E-mail: eCTD@zva.gov.lv (Amount of up to 10 Mb), signed with secure electronic signature * (created by a secure electronic signature and shall be certified by a qualified certificate).

Option No. 2

Compact discs (CD-R) and DVD discs, which were to accompany the hard copy signed by:
- cover letter (one copy). If documents are submitted to RSA in person, and requires approval of the submission, the two copies.
- Application for registration or re-registration of changes;
- RSA copy of the invoice and proof of payment, stating the invoice number of the RSA.
Documents to be submitted in electronic form


Documentation eCTD Language An electronic copy number

Registration Modules 1-5 √ EN/LV 1
Answers √ EN/LV 1


Renewal Module 1,2,5 √
EN/LV 1
Answers √

Changes if the above documentation submitted eCTD format

Change in the supporting
documentation √ EN/LV 1

Answers √ EN/LV 1

Non-eCTD (Nees) is submitted, upon request, documentation must be submitted on paper.

Still accept any documentation on paper.

* Electronic document circulation of State Agency of Medicines is provided, subject to Cabinet of Ministers No. 473 "Electronic document preparation, presentation, storage and circulation of state and local government institutions and procedures for the electronic circulation of documents between the state and local government authorities or between these institutions and natural and legal persons " and "Electronic Documents Act".

For More Information Please click: Latvia National Agency eSubmission Updates

Exalon: EMA Updates Pre-Submission and Post-Authorisation Procedural Advices

The European Medicines Agency (EMA) has updated their "procedural advice" guidance documents for user of the centralized procedure in the "pre-submission" and "post-authorisation" phase.

Changes included in the updated "pre-submission procedural advice" EMA/339324/2007, May 2011

For More Information Please click : Exalon-EMA Procedural Advice

Evaluating the Electronic Submissions Challenge – Sponsored Whitepaper

For More Information Please use the following weblink: Free eSubmission White Paper

Exalon:Updated EU Region Q&A and Electronic Submission Specifications & Guidances Change Request Document released

A new version of the "EU Region Question & Answer and Electronic Submission Specifications & Guidances Change Request Document" has been released today by the European Medicines Agency (EMA). The new version 1.25.4 has the official version date "March 2011". Several updates were included as agreed on meetings of the TIGes Joint Group and the eSubmission Change Control Board. Updates include the addition of new Change Requests (CRs), incorporation of Revisions and the moving of "Rejected" and "Closed" CRs to the corresponding spreadsheets.

For More Information Please click : Exalon Updated EU Region Q&A

New version of the "eValidator" released by BfArM

A new version of the "eValidator" eCTD / NeeS validation software used by German BfArM (developed by Lorenz Life Science, wwww.lorenz.cc) has been released. The new version of the "eValidator" includes a service pack that integrates the current draft EU validation criteria for eCTD (version 3.1) and NeeS (version 2.1) that will come into force on September 2011.

For More Information Please click: BfArM eValidator

Navigating PDFs: Bookmarks vs Table of Contents

Concepts of document navigation tools such as Bookmarks and Tables of Contents have been around for centuries. However, they’re often under or misused, so I wanted to go back to the basics here, and talk about what these items really are today, and where they are – and are not – appropriate.

For More Information about this Article please click: Bookmarks Vs TOC

FDA Webinar: Overview of the Drug Registration and Listing System (DRLS & eDRLS) – May 12, 2011

The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program is delighted to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series will highlight various aspects of drug regulation.

These focused webinars will support the Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business with information relating to the development and regulation of human drug products.

On Thursday, May 12, 2011, at 11AM (EDT), we will present our next webinar titled 'Overview of the Drug Registration and Listing System (DRLS & eDRLS)' which will discuss pertinent regulations and guidances, and submission sequences of the electronic registration and listing process.

Overview of the Drug Registration and Listing System (DRLS & eDRLS) will be presented by Paul Loebach, Team Leader for the Drug Registration and Listing Team in the Division of Compliance Risk Management & Surveillance (DCRMS), Office of Compliance, CDER.

For More Information Please click: FDA DRLS and eDRLS Webinar

Danish Medicines Agency : Electronic Issuance Of Company Authorisations

On 1 June 2011, the Danish Medicines Agency will switch to issuing company authorisations electronically as a signed PDF file. This means that, as from 1 June 2011, company authorisations will no longer be sent by ordinary post.

For More Information Please click: Danish Medicines Agency - Company Authorisations

FDA: Guidance: Submission of Summary Bioequivalence Data for ANDAs Submissions

This guidance is intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) in complying with FDA’s requirements for the submission of bioequivalence (BE) data. FDA’s final rule on “Requirements for Submission of Bioequivalence Data” (the BE data rule) requires an ANDA applicant to submit data from all BE studies the applicant conducts on a drug product formulation submitted for approval, including studies that do not demonstrate that the generic product meets the current bioequivalence criteria.2 All BE studies conducted on the same drug product formulation must be submitted to the Agency as either a complete study report or a summary report of the BE data.3 The amended regulations include a definition of same drug product formulation (section 320.1(g)).
This guidance provides information on the following subjects:

• Types of ANDA submissions covered by the BE data rule.
• Recommended format for summary reports of BE studies.
• Types of formulations the Agency considers to be the same drug Product formulation for different dosage forms based on differences in composition.

For Document please click the link : FDA ANDA's Document

FDA: CDER Released Common Data Standards Issues Document

The Center for Drug Evaluation and Research (CDER) is strongly encouraging sponsors to submit data in standard form as a key part of its efforts to continue with advancement of review efficiency and quality. CDER has been collaborating with CDISC, a standards development organization (SDO), in the development of standards to represent study data submitted in support of regulatory application. Study data standards are vendor-neutral, platform-independent, and freely available via the CDISC website (www.CDISC.org). CDISC study data standards include SDTM (Study Data Tabulation Model) for representation of clinical trial tabulations, ADaM (Analysis Data Model) for clinical trial analysis files, and SEND (Standard for Exchange of Non-clinical Data) for representation of nonclinical animal toxicology studies tabulations.

Please find the document by clicking the link: FDA CDER Data Document

eCTDOffice: Free eCTD Viewer (Now Supports STF Preview)

eCTD Office eCTD Viewer is a FREE, stand-alone, super-fast, easy to use Windows desktop application for viewing and understanding the granularity and the lifecycle of electronic submissions prepared in the eCTD (Electronic Common Technical Document) format.

eCTD Viewer reduces review times, increases response times to Agency requests, and ensures faster approvals for your products.

For More Information Please click: eCTD Office Free eCTD Viewer

Exalon: AU: TGA releases guidance for paper dossiers using eCTD or NeeS as the source

The Australian Therapeutic Goods Administration (TGA) has released a new guidance document "Paper format: Requirements for industry for providing regulatory information. Using an eCTD format or a NeeS format electronic submission dossier as the source".

For More Information Please click: Exalon TGA Update

Mission3: Global Submission Strategies (Regulatory Information Management) Prsentation at DIA EDM

Mission3: Global Submission Strategies (Regulatory Information Management) Prsentation at DIA EDM

For Presentation Please use the link: DIA eCTD Regulatory Information Management