European Agency Roundup

There has been a lot going on at the various European agencies in the last few months.  This week, we look at some of the announcments and guidance that has been issued across Europe recently.

France: – Caroline AURICHE, Philippe DÜRR and Cécile LEVY from AFSSAPS spoke at EXL Pharma, presenting on Taking the plunge from paper into electronic-only in the EU – the 18-month feed-back experience of «paperlessland» in the French Health Products Safety Agency. AFSSAPS details include:

  • Accepts and encourages electronic-only (paperless) submissions since 1 July 2008
  • Accepts National and MRP/DCP procedures 
  • Accepts e-CTD or EU-NeeS
  •  Exploring a possible shift from EU-NeeS to eCTD
  •  Enforces “Once e-CTD, always e-CTD” – once first submission as eCTD, all regulatory activities accepted
  •  Attempting to shift paper  to electronic : all regulatory activities except IA/IB variations (volumetry factor)
  • EU-NeeS : IA & IB variations never accepted
  • Receives about 1/3 eCTD and about 2/3 EU-NeeS, of which roughly one half are nonconforming at the time of first submission

Germany: The Federal Institute for Drugs and Medical Devices (BfArM) announced that it will accept pure electronic filings (eCTD or NeeS) from mid-February 2010 (previously a full paper copy was required). Only those documents requiring signature will be required in papert.
The BfArM will soon add a section on “electronic filing” to its homepage (
www.bfarm.de) to consolidate information The BfArM will be making further announcements closer to the date

Austria:  In news passed on from Tim Feldgate of Applied Regulatory Consulting’s blog article Electronic submission available for human use, the AGES PharmMed now accepts, but does not require, purely electronic submissions for human use without additional paper copy, except for those documents that need to be signed: Company letter and application form.  eCTD is the preferred standard, and it is the default Nees is only a temporary solution.

Belgium: Federal Agency for Medicines and Health Products advises on automatic emails sent after eSubs uploaded in their system and passed or failed compliance requirements

Belgium: New version of the Belgian agency’s NeeS checker tool: see the agency’s e-Submissions page (you must navigate to the Human Use tab and then the eSubmissions link) (translated from the Dutch) for the file checker and associated documents.

Spain:  AEMPS has issued a new version of their NeeS guidance   ENVÍO POR PARTE DE LOS LABORATORIOS DE INFORMACIÓN EN FORMATO ELECTRÓNICO A LA AEMPS on December 22nd (in Spanish only.

UK: in The Medicines (Products for Human Use) (Amendments to Fees for Variations) Regulations 2009 ,  eCTD fees were set at a lower level than other submission types.

UK: E-SUBMISSIONS – Frequently Asked Questions (FAQ) for Vet Meds in the UK has been updated to clarify that the root folder of a Vet Meds eSubmission is part of the submission, and that following the naming conventions for files and folders (with regards to forbidden characters) is important – your submission may be rejected even for use of upper case.

Turkey: Turkish eSubs guidance (in Turkish) has been issued. per Andrew Marr “This is essentially NeeS but with specific file and folder naming in Turkish, with CTD section numbers too. I believe that the final guidance will allow Modules 4 and 5 to use the English folder and filenames.”

Cyprus: the Ministry of Health has issued GUIDANCE FOR PROVIDING REGULATORY INFORMATION IN ELECTRONIC FORMAT SUBMISSIONS.  They will accept electronic submissions within the National Procedure, the Mutual Recognition Procedure and the Decentralised Procedure in eCTD or NeeS format. However, the Cover Letter and the Application Form must be submitted in paper with an original signature.  The guidance provides information on disk and file formats, packaging and labeling, electronic signature, validation, etc.  “The Pharmaceutical Services, Ministry of Health have a strong preference for the submission of electronic regulatory information and sees clear benefits for both regulators and industry.”

Greece: the National Organization for Medicines has posted  Instructions for Filing Electronically (translated from the Greek by Google).  Human products still require M1-M3 in paper but discourage paper for modules 4 and 5.  Vet meds and labeling requirements are also discussed.

Norway: Statens legemiddelverk announced acceptance of / strong recommendation for electronic submissions 1 Jan 2010  (translated from Norwegian by Google). 

Sweden: in updates to their Electronic submissions page, MPA prefers “as far as possible be able to work solely with electronic submissions for all medical products.” From the 1st January 2010 the MPA will also accept electronic submissions in NeeS or VNtA formats for veterinary medical products within all procedures.

Bulgaria: the Bulgarian authority has issued an announcement that from 01.01.2010 all types of procedures must be in electronic format -eCTD or NeeS – for all procedure types in Bulgaria (translated by Google). They specify which documents are still required in paper in addition.  There is also a Guide for electronic submission of documents eCTD and Nees (this was issued last March).  For a more detailed discussion of Bulgaria and eSubmissions, see ForeignExchange Translations blog entry  Bulgaria catches up with e-Submissions.

Poland: the Polish agency has announced the acceptance of electronic submissions from 1 January 2010 (Nees, eCTD), with the proviso that certain specified documents must be submitted in paper form, regardless of their submission in electronic form.

P.S. I had previously announced all of this news on Twitter, albeit in abbreviated form.  Be sure to follow me on Twitter for timely updates – go to www.twitter.com/kathie_clark to follow me.

Article written by

I am GlobalSubmit’s director of professional services. My area of expertise is electronic document management and regulatory submissions, specifically eCTD. I have 12 years of biopharmaceutical industry experience in the US, Europe, Israel and Japan, concentrating on content management for Regulatory Affairs & Submissions, Clinical Development, and Manufacturing, and in submission assembly and publishing. I have worked with over 50 pharmaceutical clients. Previously, I was the practice lead for the Subject Matter Experts/Business Analysts group at First Consulting Group (FCG), now part of CSC. I supervised a group of 12 SMEs/BAs. I was instrumental in the development of the FirstDoc® suite. I developed the project delivery methodology for FirstDoc® R&D, including training materials, project plans, workshop methodology and materials, and requirements and design specifications. I managed the design and development of FirstDoc® GMP and FirstDoc® Legal. Please feel free to contact me at kathleen.clark@globalsubmit.com if you are interested in talking about eCTD products or consulting services, or if you have ideas for the blog.

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