New Rules for Clinical Investigations in Germany

1
New Rules for Clinical Investigations in Germany

• Dr. Matthias Neumann
• Federal Ministry of Health
• Berlin
• III National Conference on MD - Rome, 13-14 April
  2010

2
Clinical Investigations in Germany before 21st
March 2010

1. Manufactures/sponsors had to notify the regional
   CA. In case of an positive opinion of an Ethic
   committee they could start immediately otherwise
   they had to wait 60 days
2. The responsibility on clinical investigations was
   split on more than 70 competent authorities
3. These authorities had serious problems to keep
   the necessary expertise and manpower to fulfil
   their obligations (check of notifications,
   assessment of serious adverse incidents during
   clinical investigations)

3
Clinical Investigations in Germany before 21st
March 2010

• Ethics committees (EC) have been overloaded with
  tasks (e.g. assessment of the technical safety of
  the investigational devices)
• negative competition between EC occurred
  (faster, cheaper,.)
• In UK, FR, Switzerland annually around 20 of
  applications on clinical investigations have not
  been approved. In Germany no data on rejections
  or non-approvals available, despite around 50 of
  all European clinical investigations are
  performed in Germany.
• No or very limited data on incidents during
  clinical investigations were available

4
Clinical Investigations in Germany before 21st
March 2010
EC
EC
Notification on regional CA
Pos. EC-Opinion
Mfr/ Sponsor
EC
Start
EC
Wait for 60 days
5
Competent Authorities for Medical Devices in
Germany
ZLG Central Authority of the Laender for Health
Protection Regarding Medicinal products and
medical devices Bonn
BMG Federal Ministry for Health Berlin and Bonn
BfArM Federal Institute for Drugs and Medical
Devices Bonn
PEI Paul-Ehrlich-Institute Langen
DIMDI German Institute of Medical Documentation
and Information Bonn
Highest Laender Authorities
6
Clinical Investigations in Germany after 21st
March 2010

• Centralisation of responsibilities
• Mfr/Sponsor of a clinical investigation need an
  approval of Federal Competent Authority (BfArM or
  PEI) and a positive opinion on the clinical
  investigational plan by an Ethics committee (EC)
• The approval by the authority will be issued
  within 30 days (otherwise fictional approval)
• The EC has to decided within 60 days
• Tasks of CA and EC are clearly separated
• CA - scientific and technical analysis of the
  device safety and of the investigational plan
• EC - legal, ethical medical assessment of the
  investigational plan with regard to the existing
  rules on clinical investigations

7
Clinical Investigations in Germany before 21st
March 2010
CA
Approval or silence
30 days
Mfr/ Sponsor
Start
Electronic Application
EC
60 days
positive opinion
EUDAMED
For some low risk devices there will be an
easier and cheaper CA approval procedure
8
Clinical Investigations in Germany after 21st
March 2010

• Serious adverse events during clinical
  investigations have to be reported by the Sponsor
  and by the clinical investigator to BfArM
• This is also applicable for clinical
  investigations started before March 21st 2010
• BfArM will assess reports, conclusions and,
  actions taken by the Sponsor
• If necessary BfArM has to order a stop of a
  clinical investigation or has to withdrawal the
  approval
• BfArM/PEI will communicate with the European
  partners

9
Ordinances in preparation

• Federal Ministry of Health wanted to establish
  two additional ordinances until 21-03-2010
• Ordinance on clinical investigations
• describing the approval procedures for clinical
  investigations (CI)
• Which information have to be provided to the EC
  and CA
• What are the procedures and tasks at the CA and
  EC
• Amendments of Cl
• Surveillance of CI by the local CA etc.
• Amendment of the DIMDI-Ordinance
• Establishing an electronic application format for
  CI which will be used by the CAs and by the ECs
• New date 7th of May 2010

10
New Rules for clinical investigations in Germany
Thanks for your attention !!

• Dr. Matthias Neumann
• Federal Ministry of Health, Berlin
• III National Conference on MD - Rome, 13-14 April
  2010