Clinical trials
NOTICE TO SPONSORS OF CLINICAL TRIALS
Please be informed that the regulatory fees applicable in the Republic of Bulgaria for clinical trials submitted under Regulation (EU) No 536/2014 are determined in accordance with the "Tariff of the fees collected under the Medicinal Products in Human Medicine Act".
In regard to the adoption of the euro as the official currency in Bulgaria, there has been an update of the "Tariff of the fees collected under the Medicinal Products in Human Medicine Act", which you can find on the following link:
https://www.bda.bg/bg/%D0%BD%D0%BE%D1%80%D0%BC%D0%B0%D1%82%D0%B8%D0%B2%D0%BD%D0%B8-%D0%B0%D0%BA%D1%82%D0%BE%D0%B2%D0%B5
The bank account details can be found on the offial BDA website and on the following link:
https://www.bda.bg/bg/%D0%BA%D0%BE%D0%BD%D1%82%D0%B0%D0%BA%D1%82%D0%B8
- In the field “reason for payment” of the proof of payment, the identifier for the procedure (g clinical trial protocol number and the type of procedure (SM/IN/ASR etc.)) should be indicated.
- Please consider that according to Article 13a, para. 3 and Article 13b, para 3 respectively, of the Tariff for the fees collected under the Medicinal Products in Human Medicine Act, when the clinical trial/substantial modification under para. 1 is with an investigational medicinal product (IMP) for advanced therapy, IMP containing genetically modified organisms, or an IMP falling within the scope of item 1 of Annex I to Regulation (EC) No. 726/2004, the corresponding fee under Article 13a, 1/ Article 13b, para. 1 is collected in double amount.
Publication of clinical trial results is a fundamental element of transparency and public trust in clinical research. Regulation (EU) No 536/2014 (CTR) establishes clear requirements for the sponsors to submit a summary of trial results, accompanied by a layperson summary, to CTIS within the applicable timelines following the end of the clinical trial in all Member States concerned.
Article 37 CTR requires sponsors to submit the summary of results of the clinical trial and the layperson summary in the content and format required by Annexes IV and V of the CTR. Primary responsibility for the timely submission, the completeness and accuracy of these documents lies with the sponsor.
The European Medicines Regulatory Network remains committed to supporting the effective implementation of the requiremetns under Article 37 CTR regarding submission of a summary of the results. Moreover, CTIS provides sponsors with in-system notices and deadline reminders, which are since very recently supplemented by direct email notifications. The sponsor handbook has been revised with detailed guidance on results submission.
Bulgaria supports the timely and transparent publication of clinical trial results through CTIS and encourages sponsors to submit timely, complete and accurate scientific and layperson summaries of the results of the clinical trial in accordance with Article 37 of Regulation (EU) No 536/2014.
Further information may be found on EudraLex Volume 10 “Clinical trials Regulation (EU) NO 536/2014 Questions & Answers” on the following link:
EudraLex - Volume 10 - Clinical trials guidelines
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.
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.
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.
Read more: Recommendations to the Sponsors for managing of Clinical Trials during...
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.
