Development of clinical trials in Spain is done in conjunction with the Royal Decree 1090/2015, the ethic committees of medicines (CEIm) and the Spanish Agency of Medicines and Medical Devices (AEMPS) together with the Regulation (UE) No 536/2014 of the European Parliament and of the Council.
- realistic approval time: 5 – 6 months
Spain is ranked the second in Europe in number of performed clinical trials.; almost 4 600 trials were performed over the last 5 years. Fifty percent of these trials covered oncology therapeutic area.
Spain has been the world leader in organ donation for the last 25 years and in 2016 it broke its own record for the number of transplants carried out: 4,818 organ transplants, of these, 2,994 were kidney, 1,159 were liver, 281 were hearts, 307 were lungs, 73 were pancreas and four were intestines.
Ten diseases causing the most deaths in Spain:
Estimated deaths per 100,000 population by cause (higher than world or European average):
|Diseases||Spain||World Average||Europe Average|
|Endocrine, blood, immune disorders||7.5||5.6||5.5|
Data from World Health Organization
Investigators and sites
Spain a key player in research and development at the European and global levels. The country is an innovation and knowledge hub, with internationally renowned, highly coordinated research centres of excellence: 29 certified Health Research Institutes located in University Hospitals, 14 Networks for Co-operative Research in Health (RETICS), 12 public Research Institutes.
Spain has very efficient public health system. It has a broad portfolio of universal and free access services, with full pharmaceutical provision. The National Health System has more than 13,144 primary healthcare centres, a large emergencies network, 453 public and 340 private hospitals.
There are more than 112,000 medical professionals and 164,000 nursing professionals with a high level of qualifications and specialization.
Over the last years Spain has been specializing in clinical trials and now many hospitals have their own research unit with people focused in clinical trials, in possession of the GCP certificate and with systems that meet all requirements to assure high quality clinical trials both in terms of data and patients’ safety.