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Time-table
04.10.00 - No signs for a regulation concerning
e-submissions in Germany (even on
request). 05.10.00 - 1st draft of an ordinance.
Request for comments till 13.10.00 (date of paper
27.09.00 date for coming into operation
01.01.01) by the German Ministery of Health
(BMG). 17.11.00 - Notice from the BMG about the
submission of a (completly new) final draft to
the Federal Council for approval in a meeting in
december the 21th. 28.11.00 - Industry comment to
the Federal Council and to the expert commitee of
health. 06.12.00 - Approval of the ordinance by
the expert committee of health. 21.12.00 -
Approval by the Federal Council. 01.01.01 - Date
of coming into operation without any transitional
period.
Not more than 87 days from the submission of the
first information till the date for coming into
operation. No discussions before !
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Technical details

• e-Mail submission of documents as attachments
• predefined Mail-bodytext (5 lines) with
  submission-specific information
• text in RTF-format (PDF not allowed for text)
• pictures must be converted into seperate
  PDF-files (link in text)
• files could be "zipped" (winzip)
• industry is allowed to use PGP for encoding
  (public key published)
• electronic signatures must be used after the
  prerequisites for a qualified electronic
  signature have been met by the Federal Institute
  for Drugs and Medical Devices (BfArM)
• automatic check of the Mailbody-content and the
  readability of the attachments (only formal)
• automatic reply of error-messages or receipt

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First results

• According to the german drug law, applicants had
  to submit for all old medicines complementary
  dossiers till february the 1st (2001). In this
  case, the ordinance demanded the e-submission of
  the expert reports.
• 8,000 e-mails were received from 1. Jan. to 1.
  Feb.
• containing appr. 25,000 files
• largest file appr. 200 MB (via e-mail !)
• largest content appr. 350 files (zipped by
  mistake the whole local drive)
• 70 different e-mail clients were identified
• appr. 25 of e-mails received had to be rejected
• Parallel work on the e-submission of documents
  for licensing procedures , renewal procedures and
  variations following the submission-ordinance.

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Projects

• Joined working group of the three german
  pharmaceutical associatons together with the
  Federal Institute for Drugs and Medical Devices
  (BfArM)
• Pilot-project on the e-submission of whole
  variations via e-mail (started before the
  ordinance)
• Development of electronic forms for variations
• Definition of the technical and formal details
• First phase of submission of "non-real"-variation
  s
• Second phase with "real"-variations till July
• Parallel project of using electronic signatures
  according to the german Digital Signature Act
• Implementation of signature-components at the
  project-participants and the BfArM till may 2001
  followed by a submission-phase of electronically
  signed documents