News on clinical trials

As of July 1, 2013, the new Medicinal Products Act and Medical Devices Act have entered into force. Pursuant to Article 12 and Article 21 of the Acts respectively, the approval for a clinical trial of a medicinal product or medical device is issued by the minister of health, on the basis of complete documentation and a positive opinion by the Central Ethics Committee.

New deadlines, pursuant to the above Acts, for the issuing of a positive opinion by the Central Ethics Committee and of the decision by the Ministry of Health for the conduct of a clinical trial in the Republic of Croatia are 30 days each, except in the case of a clinical trial of a medicinal product intended for gene therapy, somatic cell therapy, including products containing genetically modified organisms and xenogeneic drugs. The deadline for the issuing of the opinion by the Central Ethics Committee and the decision by the Ministry of Health on substantial amendments to the clinical trial is 35 days from the duly received application.

For the Ministry of Health to be able to fulfill its obligation of entering data on approved and rejected clinical trials in Croatia into the European Clinical Trial Database, EudraCT,as of July 1, 2013, in the procedure of clinical trial approval in the Republic of Croatia, the applicants must submit to the Ministry the EudraCT Clinical Trial Application Formin English, in.xml format and in electronic form, which the Sponsor completes based on the assigned EudraCT number.