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 • 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 • The responsibility on clinical investigations was split on more than 70 competent authorities • 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 Dr. Matthias Neumann Federal Ministry of Health, Berlin III National Conference on MD - Rome, 13-14 April 2010 Thanks for your attention !!