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

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)

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

Clinical Investigations in Germany before 21st March 2010

Mfr/

Sponsor

EC

EC

EC

EC

Notification

on regional CA

Pos. EC-Opinion

Start

Wait for 60 days

Competent Authorities for Medical Devices in Germany

BfArMFederal Institute for Drugs and Medical

Devices

Bonn

ZLGCentral Authority of

the Laenderfor Health Protection Regarding Medicinal

products and medical devices

Bonn

DIMDIGerman Institute of

Medical Documentation and

Information

Bonn

PEIPaul-Ehrlich-

Institute Langen

BMGFederal Ministry for

Health

Berlin and Bonn

Highest Laender Authorities

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

Clinical Investigations in Germany before 21st March 2010

Mfr/

Sponsor

EC

CA

60 days

30 days*

Start

Approval or silence

positive opinion

Electronic

Application

* For some low risk devices there will be an easier

and cheaper CA approval procedure

EUDAMED

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

Ordinances in preparation

Federal Ministry of Health wanted to establish two additional ordinances until 21-03-2010

1. 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.

2. 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

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

Thanks for your attention !!