Regulatory
Supervision of clinical trials in the Czech Republic falls under the responsibility of the State Institute for Drug Control (SUKL), which now is under direct control of the Ministry of Health. One of the main missions of the institute is to ensure that all medicines available on the Czech market meet quality, safety, and efficacy standards. All clinical trials performed in the Czech Republic must be approved by the Ethics Committee. Czech Republic has been a EU member since 2004 and its legislation has been almost fully harmonized with the EU including the Drug Law, which simplifies approval procedures.