EMA: VNeeS submissions to be 100% compliant to guideline by June 01, 2012

Since January 2010, the Agency has accepted electronic submissions for applications for veterinary medicinal products or MRLs. Such applications should be submitted in line with the Guideline on the specifications for provision of an electronic submission (e-submission) for a veterinary medicinal product (“e-submission guideline”). Taking into account that this procedure of submitting electronic dossiers was new and that both regulatory authorities and applicants had to adjust their internal procedures to comply with e-submission requirements, the Agency accepted up to now dossier submissions not fully in line with these requirements. The electronic submissions are sent as CD or DVD, particularly initial applications, but updates of dossiers and responses to list of questions or post-authorisation applications are often submitted via EudraLink/e-mail. These EudraLink/e-mail submissions are not always sent via a central address, which may cause delays or inconsistencies in archiving.

To find more information please use the below mentioned weblink

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/04/WC500126455.pdf

European Medicines Agency publishes new versions of controlled vocabularies used to comply with Article 57 (2) requirements on submission of information on medicines

European Medicines Agency publishes new versions of controlled vocabularies used to comply with Article 57 (2) requirements on submission of information on medicines

The European Medicines Agency has published a set of updated versions of Extended EudraVigilance product report message (XEVMPD) controlled vocabularies. These vocabularies support marketing authorisation holder compliance with Article 57(2) of the 2010 pharmacovigilance legislation which requires marketing authorisation holders to submit information to the Agency electronically on all medicines for human use authorised in the European Union by 2 July 2012.

To find more information please use the below mentioned weblink

 European Medicines Agency publishes new versions of controlled vocabularies used to comply with Article 57 (2) requirements on submission of information on medicines

 

Health Canada: Non-electronic Common Technical Document (eCTD) Hybrid Pilot

In March 2010, Health Canada began the Non-eCTD Hybrid Pilot as a transitory aid for sponsors not yet ready to submit in eCTD format.  A regulatory activity in Non-eCTD Hybrid format is a full electronic regulatory activity that is accompanied by Modules 1 and 2 in paper-based format.  This interim provision allowed Health Canada to reduce the amount of paper being received and enabled review of the regulatory activity in electronic format.

Health Canada believes that sufficient time has been provided to facilitate transition to eCTD format.  In addition, processing of the Non-eCTD Hybrid format has increased the time of handling and validation of regulatory activities in this format relative to regulatory activities in eCTD format.  For these reasons, Health Canada is considering ending the Non-eCTD Hybrid Pilot at the end of March 2013 and would like to encourage sponsors to transition to the eCTD format as soon as possible to expedite the elimination of paper from the regulatory review process.

 To find more information please use the below mentioned weblink

Health Canada: Non-electronic Common Technical Document (eCTD) Hybrid Pilot

Centralised European pharma marketing applications can now be made online

Applications under Europe’s centralised marketing authorisation process can now be made online after the EMA’s eSubmission Gateway went live yesterday.

The online portal is now fully open for human medicine applications and the European pharma regulator said the move was an important milestone in its long-term strategy to move towards electronic applications submission.

A pilot of the Gateway saw it opened for a limited number of applicants from January to April this year and the EMA judged this a success, saying that the speed and efficiency applications submitted was increased.

The pilot also saw benefits for the pharmaceutical industry, in the form of reduced costs, according to the EMA.

The eSubmission Gateway is an electronic submission channel that allows applicants to securely submit documents supporting all types of applications for human medicines using the Electronic Common Technical Document(eCTD) format.

Companies wishing to use the Gateway need to have access to the Electronic Standards for the Transfer of Regulatory Information (ESTRI) Gateway, but those that participated in the pilot can continue to submit applications without having to register again.

The EMA said it would continue to accept submissions made on physical media, such as CDs or DVDs, but doesn’t want duplicate submissions if companies are using the Gateway.

One of the next steps in the EMA’s eSubmission Gateway project will see a web-based submission client developed for low-transmission volumes, which the EMA said may be more suitable for small and medium-sized companies. This will be available by the end of this year.

To find more information please use the below mentioned weblink

Centralised European pharma marketing applications can now be made online

 

EMA: Electronic application form pilot to be extended to initial veterinary applications

On 2 May 2012, the European Medicines Agency is extending its pilot of electronic application forms to include initial applications for marketing authorisations of veterinary medicines.

The pilot, which started last month, currently only allows pharmaceutical companies to apply for initial marketing authorisation applications for human medicines, and for variation and renewal applications for human and veterinary medicines. From 2 May, initial veterinary applications, including applications for extensions of marketing authorisations, will also be accepted.

To find more information please use the below mentioned weblink

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/04/news_detail_001497.jsp&mid=WC0b01ac058004d5c1&jsenabled=true

Pharma eReport Blog: EudraVigilance XEVMPD e-learning course coming very soon

We understand that the EudraVigilance e-learning XEVMPD course will be released "at the end of April at the latest".  The EMA has confirmed that "following a successful completion of the competency assessment, users will receive an XEVMPD training certificate."  This is good news, and will be a very welcome resource.

The current on-site courses offered by the EMA are aimed at facilitating the practical implementation of the requirements, including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU). The two-day on-site training courses focus on explaining the guidance, specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, and applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM).

To find more information please use the below mentioned weblink

 Pharma eReport Blog: EudraVigilance XEVMPD e-learning course coming very soon

EMA eSubmission Gateway now live

European Medicines Agency's eSubmission Gateway is now live for all applications for centralized marketing authorizations for human medicines. As per the EMA Press release today EMA has mentioned this is an important milestone in the Agency's long-term strategy for the electronic submission of applications, which aims to improve efficiency and decrease costs for applicants.

The eSubmission Pilot  was opened to a limited number of applicants from January 2012 to April 2012. The Agency saw an increase in the speed and efficiency of the application process. This success has led to the Agency's decision to extend the use of the Gateway to all applicants.

To find more information please use the below mentioned weblink

EMA eSubmission Gateway now live....

CDISC: Setting Standards for the Study of Pain

The Clinical Data Interchange Standards Consortium (CDISC) is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

One specific area in which CDISC is involved centers around the wealth of information to be had through access to the electronic health record (EHR). If research sponsors begin to use EHRs to support data collection to streamline clinical studies, the next step is to automate the EHR to identify a potential research candidate, schedule that patient for the study visits and facilitate the entry of subjects into studies. CDISC is participating with the Mayo Clinic, Intermountain Healthcare, IBM Watson Research Labs (Watson computers and natural language processing), and others in an attempt to achieve the Holy Grail of interoperability in clinical research.

It is the CDISC vision to inform patient care by improving data quality and patient safety. The goal is to accelerate the cycle through which research informs healthcare and thus the opportunity to bring new therapies to patients sooner.

Regarding the study of pain, CDISC recently posted their likely Therapeutic Area Standard for pain on the CDISC website, for public review. Hopefully, this tool will allow for the organization of standard pain clinical trial data submitted to regulatory bodies such as the United States Food and Drug Administration (FDA). This is important, as one hypothesis as to the failure of so many pain-relief medications when studied in clinical trials centers on the inconsistent quality of the type of data collected.

To find more information click here

  

CDISC: Setting Standards for the Study of Pain

 

Exalon: Exalon to speak on XEVMPD workshops organized by Lorenz Life Science Group

Dr. Michael Braun of Exalon will speak on several free XEVMPD workshops organized by one of our partners, the Lorenz Life Science Group.

Michael will give an overview presentation on the subject matter, including the background regulation, the development of the XEVPRM standard over the past months, the current XEVMPD requirements as well as the particular challenges for marketing authorisation holders that need to comply with the XEVMPD mandate. 

To find more information please click here

http://www.exalon.com/ectd-news/news-details/article/exalon-to-speak-on-xevmpd-workshops-organized-by-lorenz-life-science-group.html

Exalon: EU CMDh updates guidance documents for the submission of variations

The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released updated guidance documents regarding the submission and processing of variation applications in MRP/DCP.

To find more information please click here

http://www.exalon.com/ectd-news/news-details/article/eu-cmdh-updates-guidance-documents-for-the-submission-of-variations-1.html

Exalon: Health Canada releases Draft for consultation: Preparation of Drug Regulatory Activities in eCTD

Health Canada has released a new draft version of their guidance document "Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD)" for a 60-day consultation period. Once final, it will replace the "2009 Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document Format."

The guidance document "defines the electronic format requirements and process, as well as provides additional guidance on the structure and content of information to be included in regulatory activities in eCTD format. It provides a few examples of documents and their locations in the new structure define in the revised Canadian Module 1 Backbone".

To find more information please click here

http://www.exalon.com/ectd-news/news-details/article/health-canada-releases-draft-for-consultation-preparation-of-drug-regulatory-activities-in-ectd.html

EMA: Electronic Application Form (eAF): Application for Variation to a Marketing Authorisation - Release Notes (Version - 1.2.24)

EMA has released Electronic Application Form (eAF): Application for Variation to a Marketing Authorisation - Release Notes (Version - 1.2.24) document, This document lists and briefly describes the new features and fixed issues included in the release of the electronic application form: Application for Variation to a Marketing Authorisation.

Following information we can find in the document.

Version content
Issues fixed for this version
Known issues
Additional information

Use the below mentioned weblink to download the document.

http://esubmission.emea.europa.eu/eaf/docs/eAF-Release-Notes-Variation.pdf

RAPS: Mastering the eCTD Format Critical for Regulatory Submissions Pros - By Zachary Brousseau

The electronic Common Technical Document (eCTD) is designed to make regulatory submissions easier and more efficient—for drugmakers and for regulators. It provides a common global standard for companies to electronically submit the quality, safety and efficacy information required for approval of a new drug to regulatory agencies in the US, EU, Canada and Japan.

In the US, the reauthorization and update of the Prescription Drug User Fee Act (PDUFA), which expires later this year—the updated bill is dubbed PDUFA V as it is to be the fifth iteration of the user fee law—is set to elevate the eCTD format to a requirement for all New Drug Applications (NDAs) and Biologics License Application (BLAs) beginning in 2015, and for Investigational New Drug Applications (INDs) beginning in 2016. It has been required for Centralised Procedure applications to the European Medicines Agency (EMA) since 2010. Use of the format is also strongly encouraged in Canada, Japan and emerging markets around the globe. Therefore, anyone who works on drug regulatory submissions needs to understand the format well.

Although it is likely to become an FDA requirement only this year, the eCTD is not new. The eCTD’s paper-based predecessor, the Common Technical Document (CTD), was developed by the International Conference on Harmonisation (ICH) in 2000, and the eCTD evolved in 2003.

The eCTD benefits regulators by allowing them to use computer-based tools such as searching, copying and pasting text, making the review process more efficient. Regulators can complete reviews online, allowing for more timely reviews to meet legislative timelines, which ultimately benefits sponsors, as well. For sponsors, eCTD submissions can be less expensive to produce and ship, provided they have properly refined business processes to accommodate the change from the paper-based format to an all-electronic one.

To find more information about this article please click here

 RAPS: Mastering the eCTD Format Critical for Regulatory Submissions Pros - By Zachary Brousseau

Health Canada: Module 1 - Consultation Document - Draft Guidance for Industry: Creation of the Canadian Module 1 Backbone

Health Canada is pleased to announce the release of the Draft Guidance for Industry: Creation of the Canadian Module 1 Backbone for a 30 day consultation period. Once final, it will replace the 2004 Guidance for Industry: Creation of the Canadian Module 1 eCTD Backbone File.

This guidance document outlines the creation of a regional backbone file according to the Canadian Module 1 schema. The Canadian Module 1 Schema files are to be used in the preparation and filing of drug regulatory activities in the electronic Common Technical Document (eCTD) format established by the International Conference on Harmonization (ICH).

This draft guidance document is meant be read in conjunction with:

• Draft Canadian Module 1 Schema Version 2.1;

• Draft Guidance for Industry: Preparation of Drug Regulatory Activities in Electronic Common  Technical Document (eCTD) Format.

It is expected that this document will be further modified based on comments received during the consultation period. It should be noted that, although Clinical Trial Applications (CTA) and Drug Master Files (DMFs) are included in the schema, they are not yet accepted in the eCTD format. Please consult the Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format to verify the scope of regulatory activities accepted in the eCTD format

To find more information please use the below mentioned weblink

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/draft_ebauche_ectd_mod1_guide-ld-eng.php

Five Key Practices for a Successful EDMS - By Kathie Clark, NextDocs

The electronic document management system (EDMS), as we know it, has been available for almost 20 years. In the early days, all projects involved simple, out-of-the-box deployments or customized projects. Specialized EDMS projects serving specific industries or processes emerged in the late 1990s. Today, these specialized systems provide mature and full-featured solutions to many business problems, managing the content and associated processes for engineering, manufacturing, regulatory compliance, legal contracts, human resources and much more.

A successful implementation of an EDMS yields organization improvements and cost benefits. An EDMS can standardize and streamline the content management processes, reduce or eliminate paper use, improve records management for corporate and legal purposes and allow for access control and other security features to protect intellectual property and comply with privacy regulations and practices.

So why are many EDMS projects still unsuccessful? Many organizations still fail to understand the discipline necessary for success. Understanding and adhering to five key practices when implementing an EDMS can dramatically increase the likelihood of delivering a successful solution.

1. Mandate for use

2. Maximized use of out-of-the-box software

3. The Pareto principle (the 80-20 rule)

4. Simplicity

5. The voice of experience

To find more information please us the below mentioned weblink 

Five Key Practices for a Successful EDMS - By Kathie Clark, NextDocs