The approval process is following the EU legislation (clinical trial directive 2001/20 EC), including the German Medicinal Drug Law.
- realistic approval time: 4 months
Competent Authorities in Germany
Three specialized Competent Authorities (CAs) divide responsibilities in different fields of clinical trials.
Paul Ehrlich Institute (PEI) in Langen is the CA for sera, vaccines, blood preparations, bone marrow products, tissue preparations, allergen tests, antigen tests, gene transfer medicinal products, somatic cell therapy medicinal products, xenogenic cell therapy medicinal products and genetically engineered blood components.
Federal Institute for Drugs and Medical Devices (BfArM) is the CA for all other medicinal products including medical devices.
DIMDI Online notification system for medical device studies. Regional CAs are responsible for certain kinds of medical devices (implants, active, non-active).
Germany is number 3 worldwide in the number of pivotal clinical trials and number 2 EU-wide with regard to patients recruited per pivotal clinical trial in marketing authorisation applications, submitted to the EMA.
The three most often tested therapeutic areas are: oncology, infectious diseases and cardiology.
Estimated deaths per 100,000 population by cause (higher than world/European average):
|Diseases||Germany||World Average||Europe Average|
|Endocrine, blood, immune disorders||9.7||5.6||5.5|
|Mental and substance use disorders||9.5||4.3||11.1|
Data from World Health Organization
Investigators and Sites
With over 2,000 hospitals and 340,000 physicians of whom two-thirds are specialists, Germany offers the highest standards of treatment and diagnostic procedures. In 2010, Germany had 3.7 physicians per 1,000 population, above the OECD average of 3.1. Both public and private hospitals, as well as outpatient clinics are well organized and set up to fulfill the highest national requirements of clinical research. Well-experienced and qualified investigational staff ensure high quality clinical trial conduct.
With 281 pivotal clinical trial sites, Germany is ranked third in the world.
Established internationally recognized expert groups led by the national and international key opinion leaders, specific associations and patient organizations, as well as investigator network groups, ensure access to specific patient populations, including those with rare diseases.