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Clinical trials

Clinical trials

For the assessment of an annual safety report (ASR) under Commission Implementing Regulation (EU) 2022/20, of an active substance in clinical trials authorised in at least two Member States in EU (regardless of whether the clinical trials in question were authorised under Regulation (EU) No 536/2014 or initially under Directive 2001/20/EC and subsequently under Regulation (EU) No 536/2014) and Bulgaria is selected as the Safety assessing Member State, a fee is levied in the amount specified in Art. 13c of the Tariff for the fees collected under the Medicinal Products in Human Medicine Act - 1,800 (one thousand eight hundred) BGN.

In the "purpose of payment/remittance information" field in the proof of payment document, the type of procedure- assessment of an annual safety report and the number of the report - ASR ID should be indicated.

Bank Information:

IBAN: BG85 UNCR 7630 3100 1128 90

BIC: UNCRBGSF

BANK: UniCredit Bulbank AD

A Cover Letter (in English) should be submitted along with ASR submission in CTIS. The Cover Letter should contain the names of all MSs concerned for all ongoing CTs in EU/EEA within Directive as well as Clinical Trials Regulation, and for CTs under the CTD a list of all MSC with CTs under the CTD and the respective EudraCT numbers at time of ASR submission is required.

Clinical trials

Dear Sir/Madam,

We have the pleasure to present to your attention our first Clinical Trials Information System newsletter “CTIS Highlights”, which will be published twice a year. The newsletter will provide you with insights on the development of CTIS. We believe that the information it provides will be interesting and useful for your work.

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Clinical trials

Due to the complicated situation of increased risk of COVID-19 and the declared State of emergency in the Republic of Bulgaria, many additional factors will influence the conduct of clinical trials in sites on the territory of the country - limited access to medical establishments, limited resources etc.

The patients’ safety and health is a main priority and the changes in the conduct of clinical trials must be based on a detailed risk assessment.

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Clinical trials

We would like to inform you that the “Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014” has been launched on the EMA website for public consultation. Please find the link below for your convenience:

Draft proposal for an addendum, on transparency, to the 'Functional specifications for the European Union portal and EU database to be audited'

Please submit your comments using the template form, which is available through a link in the cover page of this document.

Please forward your comments to This email address is being protected from spambots. You need JavaScript enabled to view it. by Wednesday, 18th February 2015.