CMDh BEST PRACTICE GUIDES FOR THE SUBMISSION AND PROCESSING OF VARIATIONS IN THE MUTUAL RECOGNITION PROCEDURE - Rev 16 and Release date is 26th March 2012.

Heads of Medicines Agencies (CMDh) has released updated version (ver 16) BEST PRACTICE GUIDES FOR THE SUBMISSION AND PROCESSING OF VARIATIONS IN THE MUTUAL RECOGNITION PROCEDURE guidance on 26th March 2012.

Please use the below mentioned link to find the updated guidance.

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_094_2003_Rev16_-_clean_2012_03.pdf

CSC: Guidance Delivers Much that’s Expected, but Some Surprises - By Andrew Marr, Managing Director, Marr Consultancy Ltd.

The release of the EMA’s EVMPD guidance has given industry much of the clarification it needs for moving forward – some of it expected, but some of it a surprise.

One change that caught the industry by surprise is the requirement to list products that are authorised for use in children. This was not mentioned at the meeting with industry groups or at the Information Day EMA held in the lead up to its guidance release. What is now required is if a product has an indication in children or dosing recommendation for children, then it must be flagged as being authorised for use in children in the comments field. Unfortunately, this is not a dedicated field.

This presents some challenges because companies will have to collect pieces of information as a flag and place text – perhaps with the aid of software – in the comments field, which may already be used for other purposes. In particular, this is additional workload for companies that have already gone through all their product information. Now they have to go through the information again to check whether there is mention of use in children. While it’s easy enough to do, it’s a logistical exercise that potentially forces companies to backtrack on their information search.

While the new guidance offers clarification on many issues, there is one area where that’s not the case. The agency has decided to postpone releasing the life cycle management guidance associated with how to do manage the changes until after a meeting to be scheduled in April or May with trade associations. Technically the infrastructure is there in the specification, but any question or detail around how to do it, timing, etc. has gone unanswered in this guidance and the agency has simply said it will announce this after meeting with trade associations.

To find more information please use the below mentioned weblink

http://www.csc.com/health_services/blog/74101/80513-guidance_delivers_much_that_s_expected_but_some_surprises

 

Mission3 News Letter: Saudi Food and Drug Authority (SFDA)- Moving Towards The Acceptance of Electronic Submissions - By Shakul Hameed, Founder, eCTD Regulatory Submission Network

An electronic Submission (or eSubmission) is a set of registration files submitted in electronic format to Health Authorities. The main reasons for submitting electronically are to improve the submission review process, increase accuracy of the submission, and decrease the total costs.

The Saudi Food and Drug Authority (SFDA) recently released a Guidance for Submission (Version 3.0) and a Module 1 eCTD Specification guidance Version 1.0 for GCC (Gulf Cooperation Council). In both guidance documents, SFDA discusses their electronic submission requirements and their plans to implement the eSubmission standards on a step-by-step basis.

SFDA started to accept the NeeS (Non-eCTD electronic submission) format for human medicine submissions, and they are planning to make it mandatory starting from September 1, 2012.  This is an interim step as SFDA moves towards mandating only eCTD Submissions.

To find more information please click here 

http://mission3.com/company/newsletter/106

Mission3 News Letter: Saudi Food and Drug Authority (SFDA)- Moving Towards The Acceptance of Electronic Submissions & Integration Matters – Regulatory Information Management Strategies

Mission3 has published news letter for the month of March 2012 on their website. please find the following new letter

Saudi Food and Drug Authority (SFDA)- Moving Towards The Acceptance of Electronic Submissions - By  Shakul Hameed, Founder, eCTD Regulatory Submission Network

http://mission3.com/company/newsletter/106

Integration Matters – Regulatory Information Management Strategies

http://mission3.com/company/newsletter/104

Companies In Crisis. What's Your Plan?

http://mission3.com/company/newsletter/105

CSC: EMA Guidance Gives the Industry Much-Needed Clarification - By Andrew Marr

After a period of waiting, the industry at last has some clearer information on the EVMPD with the release of new guidance from the EMA.

To start with, the agency confirmed that the structured substance information (SSI) would not be required for the 2nd July start date. At some point the data will need to be provided by somebody, and the agency will discuss that with industry after 2nd July and plan some form of roadmap for the provision of SSI data.

The next major change concerns labelling, with the EMA noting that the Summary of Product Characteristics (SmPC) is all that is required for labelling. The agency has done away with the requirement for the package insert, the labelling, and the Annex II for Centralised Procedure (CP).

There are also some options for the language SmPC is provided in. For CP it’s only the English, as expected. For the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) the preference is for the national language or languages, where relevant, but the EMA will accept the English common agreed text. For those companies choosing this approach, it does mean far fewer documents (and thus fewer resources), though it makes the EMA’s validation more difficult because regulators will have to check databases for information not included in the English common version. For National Procedure products, companies will be required to use the national language (or languages) for product information.

To find more information please use the below mentioned weblink

CSC: EMA Guidance Gives the Industry Much-Needed Clarification - By Andrew Marr

GlobalSubmit: PDUFA V and the Impact on You

In September, the FDA issued its Proposed PDUFA V Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017.

There are many proposed improvements related to the FDA review procedures, including a mandate of the eCTD. This mandate will start 24-months after publication of the corresponding final guidance for marketing applications and 36-months after publication of the final guidance for commercial INDs and amendments.

The final guidance will be released no later than 12 months from the close of a public consultation period on the draft guidance. The corresponding draft guidance will be issued by December 31, 2012 at the very latest. The initial guidance will reference eCTD version 3.2.2; however, the final guidance might refer to a different standard, namely RPS, if the FDA determines the new standard is more efficient and effective. The FDA also mentions that they “shall also accept submissions using the previous version for no less than twenty-four (24) months.”

Although many of the goals for priority and standard NDA and BLA review (including Class 1 and Class 2 resubmissions, efficacy supplements, and manufacturing supplements) remain the same as under PDUFA IV, the proposed PDUFA V agreement establishes a new review model that will apply to all New Molecular Entity (“NME”) NDAs and original BLAs received from October 1, 2012 through September 30, 2017, including applications that are resubmitted following a refuse-to-file action.

Please use the below mentioned weblink to find more information

http://theectdsummit.com/?p=1968

EMA: eXtended EV Medicinal Product Dictionary (XEVMPD) Training Programme

20-21 March 2012, London
22-23 March 2012, London
29-30 March 2012, Vienna
10-11 April 2012, London
12-13 April 2012, London
16-17 April 2012, London
23-24 April 2012, London
3-4 May 2012, London
07-08 May 2012, London
07-08 May 2012, Horsham (USA)
10-11 May 2012, London
14-15 May 2012, London
24-25 May 2012, London
29-30 May 2012, London
21-22 June 2012, San Marino
28-29 June 2012, Lisbon

Top find more information please use the below mentioned weblink

http://eudravigilance.ema.europa.eu/human/training5.asp

Pharma eReport Blog: Seven reasons to invest in an EVPRM system

Why should you invest in an EVPRM system if the EMA will be releasing a free one?   

Now that the race really is on to meet the July 2^nd 2012 EVMPD compliance deadline, it’s a question that might occur to some Marketing Authorisation Holders as they start their vendor solution appraisals and selection process.  So, below is a brief response outlining why organisations need a vendor-supplied EVPRM system.  Here's seven reasons...

1. The EMA system will not support your existing key business processes, such as efficient product life cycle management. The EMA system will not provide the capability to store past messages for you in a way that enables proper life cycle management and a robust audit trail.   A custom, professional-grade EVPRM system will offer a centralised database that efficiently tracks and logs all user activity, change tracking, and should also offer full harmonisation with your existing systems.  Additionally, with a custom system, the data can reside on your side and not with the EMA, allowing you to extract maximum value from your product information.

2. The EMA tool will be a simple linear, web-form data entry tool – one allowing you to enter details for one MA at a time.   Our Centrality solution provides a choice of data entry options:

• Simple fill-form: you can enter your Marketing Authorisation (MA) data sequentially, completing each section as needed. This solution follows the XML specification and documentation and is optimal for organisations submitting a small number of MAs (fewer than 10).

 
To find more information please use the below mentioned weblink 

http://www.pharmaereport.com/content/blog.php?h=Seven-reasons-to-invest-in-an-EVPRM-system

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.  

In the practical session of the workshop, Dr. Sebastion Knieps of Lionpharm will demonstrate how the challenges can be adressed by using the Lorenz "drugTrack" XEVMPD and Regulatory Tracking solution. 

To find more information and Registration please use the below mentioned weblink

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

 

The Swedish Medical Products Agency: Changes to the procedure for requesting time slots with Sweden acting as reference member state in the decentralised procedure

The Swedish Medical Products Agency participates actively in the decentralised procedure as reference member state (RMS) and has since the start received a high number of requests for time slots. 

As from 1 February 2009 a new procedure for requesting time slots was introduced, in order to better schedule expected applications and optimising the use of our resources. 

This procedure is continuously reviewed and revised in accordance with the number of requests received. As of 1 March 2012 some new changes to the procedure of requesting time slots are introduced. 

To find more information please use the below mentioned weblink 

http://www.lakemedelsverket.se/english/All-news/NYHETER-2012/Changes-in-procedure-for-requesting-Sweden-as-RMS-in-DCP/

CSC: Race to the Finish: Overcoming Barriers to EVMPD Implementation - Webinar

With just three months to go to the EVMPD deadline, the industry is working hard to gather and prepare the product data required to meet the EMA mandate. Companies are now fully aware that the deadline won't move. But the same can't be said for the EMA's own targets. Promised dates for guidances and releases have come and gone without the much-needed information; questions remain unanswered; decisions are being made without proper consultation or even warning; and the deadline on the EMA's own database has now been dragged out until mid-April.
Beyond July 2, companies will need to have an eye on the ISO IDMP standards, which will replace EVMPD once implemented in 2015. Both EVMPD and its eventual successor, the IDMP, underscore the need for better management of the regulatory data that surrounds each product, and industry will need to give careful consideration to how best to move forward.
Join CSC's timely Webinar to learn what's happening with the EVMPD and what your priorities should be in the final months before the July 2 mandate becomes effective.
Please use the below mentioned weblink to register
http://events.imagesolutions.com/g/?DSKQMQE2RU:J03UD6MBIH=ssID:924162701

MARR CONSULTANCY: Andrew Marr assesses the changes and impacts of the revised XEVMPD guidance of 5 March 2012

Andrew Marr re-assesses the impact of the revised guidance on XEVMPD issued by EMA on 5 March 2012

EVMPD data are still required to be submitted to EMA for all authorised medicinal products in Europe by 2 July 2012 but the scope of the data required is reduced.

To find more information about this articile please use the below mentioned weblink

http://marrconsultancy.com/2012/03/15/andrew-marr-assesses-the-changes-and-impacts-of-the-revised-xevmpd-guidance-of-5-march-2012/

EMA eSubmission Gateway: Questions and answers document has been Updated

eSubmission Gateway Questions and answers relating to practical and technical aspects of the implementation document has been updated by EMA.

This question and answer document aims to address the commonly-asked questions and provide guidance regarding technical and practical aspects of the European Medicines Agency’s eSubmission Gateway for electronic submissions as part of the Centralised Procedure.

Please use the following link to find the updated guidance

http://esubmission.ema.europa.eu/gateway/Q%20&%20A%20for%20EMA%20eSubmission%20Gateway.pdf

Pharma eReport Blog: EVMPD spreadsheet for data entry freely available on our website

We have just made available on our website an Excel spreadsheet for data entry. If you prefer to enter your data in Excel, then you can use this spreadsheet to log your information and we will be able to import, check and convert the data to compliant XML.

http://www.pharmaereport.com/content/blog.php?h=EVMPD-spreadsheet-for-data-entry-freely-available-on-our-website

Medical Translation Insight: Ready for e-labeling?

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices.

Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.

To find more information use the below mentioned weblink

http://blog.fxtrans.com/2012/03/ready-for-e-labeling.html

ELC Group: EVMPD Excel sheet

ELC Group made available an excel spreadsheet for data entry. If you prefer to enter your data in excel, then use this spreadsheet and we will be able to import, check and convert the data to compliant XML. 

To download xEVMPD Excel spreadsheet click here  - http://t.co/wq6bw3E7

EMA: Updates on XEMVPD - at last EMA has posted updated specification requirements, frequently asked question documents and Vocabularies

EMA: Updates on XEMVPD - at last EMA has posted updated specification requirements, frequently asked question documents and Vocabularies.

To find the documents please use the below mentioned weblink

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000336.jsp&mid=WC0b01ac05804d8b2b&jsenabled=true

European Medicines Agency (EMA) launches electronic application form pilot for CP Submissions

The European Medicines Agency has launched a pilot of electronic application form for submissions of centralized marketing authorization applications on Monday (12th March 2012).

The pilot, which runs for four months until mid-July 2012, allows pharmaceutical companies to apply for initial marketing authorization applications for human medicines, and variation and renewal applications for human and veterinary medicines, using an interactive PDF form.

The pilot is a key step forward in the Agency's drive towards the use of electronic applications as standard, using the eCTD format. This is expected to simplify and speed up the application process by:

• improving data quality and consistency;
• providing access to data in Extensible Markup Language (XML) format;
• integrating application data with controlled vocabulary lists.

The forms were developed by the European Medicines Agency, working together with the European Commission services and medicines regulatory authorities in European Union Member States.

To find more information please click here

European Medicines Agency (EMA) launches electronic application form pilot for CP Submissions

 

Tips for document management

It is critical that Life Sciences companies establish, document, and control their processes for authoring electronic documents, scanning paper documents, and handling each document type (e.g. CSR, Protocol, Summary, etc.) for each type of dossier (e.g. IND, NDA, BLA, PMA, eCTD, etc.). 

Each type of document will present its own challenges to regulatory publishing. All documents to be authored for a dossier should be started with a template that includes agreed upon standards. Legacy documents should be scanned in, cleaned up, bookmarked and linked; headers and footers should be masked where appropriate. Standards and quality at the beginning of the document lifecycle lead to a more consistent and reliable dossier.

To find more information please use the below mentioned weblink

http://www.ngpharma.eu.com/article/Tips-for-document-management/

Pharma eReport Blog: Updated EVMPD guidance from EMA – so what next?

The EMA has just published the long-awaited update to its EVMPD guidance, covering specifications, controlled vocabularies and more.  As anticipated, and following the discussions at the 30th January cross-industry meeting, the EMA has elected to go with “Option 3” – a significantly reduced subset of information now required to meet the xEVMPD compliance deadline of 2nd July 2012.

In a revision of its previous requirements, the EMA has decided to reduce the number of mandatory data elements, in response to European pharmaceutical industry feedback regarding the practical challenges of compliance by July 2012.   The EMA has therefore decided not to request submission of the following data elements for medicinal products by the July 2012 deadline:

    * indication if the product is subject to additional monitoring
    * location of the pharmacovigilance system master file
    * description of packaging information
    * Structured Substance Information (SSI) data reporting

To find more information please use the below mentioned weblink

 
http://www.pharmaereport.com/content/blog.php?h=Updated-EVMPD-guidance-from-EMA

XEVMPD compliance and beyond Group: Few Pharmas Expect to Meet EVMPD Deadline

Few Pharmas Expect to Meet EVMPD Deadline

Technology company's survey reveals only 15% of big pharma, 35% mid-size pharma are optimistic about submitting all required data in time

Polling conducted by the US based technology company revealed that most pharmaceutical companies are concerned about their ability to comply with the requirement to submit additional pharmacovigilance data to the EMA EudraVigilance Medicinal Product Dictionary (EVMPD) in advance of the July 2, 2012 deadline.

To find more information please use the below mentioend weblink

http://www.linkedin.com/groups/Few-Pharmas-Expect-Meet-EVMPD-4334168.S.99276687?view=&gid=4334168&type=member&item=99276687

 

EXTEDO: Webinar: The EMA Guidance on XEVMPD - Challenges and Solutions to Meet the Deadline in July 2012

Speakers:

       Remco Munnik (Regulatory Information Director, ASPHALION)

       Schei Dattner (Sales Director Global Account Team, EXTEDO)

       Christian Kravogel (Product Manager, EXTEDO)

Starting Time & Duration

       17:00 Central European Time (Barcelona, Munich, CET)

       04:00 p.m., UK Time (London, GMT)

       11:00 a.m., US Eastcoast Time (Philadelphia, EST)

       08:00 a.m., US Westcoast Time (San Francisco, PST)

Duration will be about 60 minutes.

02 July 2012 is a major deadline to complete your product information e-submission to the EMA. A new format has been defined: the Extended Eudravigilance Product Report Message (XEVPRM), and the information that needs to be submitted to the EMA is extensively described in the detailed guidance.

       But how will marketing authorization holders address this major step?

       Do we have a clear understanding of the information required on our products and how to collect this information?

       How are we going to meet the deadlines in 2012 - internally, outsourced, a mix?

       Are our IT systems ready?

During this webinar, we will address these questions and provide attendees with practical solutions to meet this crucial deadline.

ASPHALION will discuss the challenges from a regulatory service point of view including consultancy and staff augmentation through an outsourced service platform.

EXTEDO will present its new software solution MPDmanager, a Regulatory Master Data platform for XEVMPD and IDMP compliance. It supports applicants with an XEVMPD author system including wizard based data entry, it provides Excel & XML based interfaces for data import and export from various sources and it integrates with the EXTEDOsuite, product databases and other RIMS.

Registration:

The registration for this webinar is free of charge. Please register online at: https://www3.gotomeeting.com/register/623688390