07 Apr BDA: COVID-19 measures affecting clinical trials submissions
The Bulgarian Drug Agency (BDA) announced on March 10, 2021, further measures related to the risk of COVID-19. For the duration of the extraordinary epidemic situation declared by the state, the BDA will accept the documentation required for clinical trial applications and applications for substantial amendments to be submitted on digital media only (CD/DVD). However, paper submissions are still required for a number of documents, such as application forms, cover letters, declarations, power of attorneys, certificates, authorisations, insurance documents, protocol pages signed by the principal investigators, consents and confirmations by the managers of the proposed sites, as well as the proof of payment. The respective digital files need to follow the naming convention and structure advised by the BDA.