Ministry of Health is the main healthcare executive body in the Republic of Bulgaria. At the Ministry internet page you can find information about it’s structure, services for citizens and legal entities, the main legislative acts in healthcare, incl. those in process of public review. The Ethics Committee for Clinical Trials is structured under the Health Minister. More information about its activities can be found under the section for Services for Legal Entities.
EMA is the main regulatory body in the European Union (EU). At the Agency webpage you can find information about the applicable healthcare legislative acts in EU, incl. those pertaining to clinical trials, as well as additional information about the Agency’s expectations to clinical trial conduct. There you can find a Register of the centrally-registered pharmaceutical products for human use in EU member-state countries(, as well as a register of the EU-approved Clinical trials).
The EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA) which started after 1 May 2004. The European Union Clinical Trials Register allows you to search for protocol and results information on: interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA); clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
TransCelerate BioPharma Inc. is a non-profit organization with a mission to collaborate across the biopharmaceutical research and development community to drive efficient, effective and high-quality delivery of new medicines. At their webpage you can find more information about their proposed solutions, as well as information about the mutually recognized Good Clinical Practice trainings.
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.