In January 2023 EMA posted an interesting interpretation of the Pharmacovigilance Inspectors Working Group regarding Day 0 in the context of Individual Case Safety Reports (ICSRs) found in physical/hard copy local medical journals: “For ICSRs, described in the medical literature containing the minimum criteria, the clock...
We celebrated our 15th anniversary at the end of 2022! We started the company with the idea to tailor our services to the needs of the different types of companies we serve while taking into consideration the particularities of the local markets we operate in....
We are glad to announce that PharmDedict is now part of the family of the Digital Health and Innovations Cluster Bulgaria. The DHI Cluster is a non-profit organization that supports companies and organizations in the field of digital solutions and innovations in healthcare to build...
If you explore our website, you may notice some changes. This is because we refreshed the design and made a few enhancements. We hope you like it. ...
In order to achieve the most effective resolution of all regulatory matters, we have chosen to conduct business in a network of selected nationally based companies in almost all of the member states of the European Union plus Norway, Switzerland and Lichtenstein. We are proud to...
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...
Starting on 1 July 2019, the Bulgarian Drug Agency (BDA) announced they will accept submissions via CESP, the Common European Submission Portal. During the pilot phase CESP submissions were limited. From 1 July 2020 BDA resumes accepting all types of applications and documents via CESP, except...
The Bulgarian Drug Agency (BDA) announced today (March 24, 2020) further measures related to the risk of COVID-19. The measures mainly concern the flow of communication with the agency. The primary aim is to encourage remote submissions and to reduce the number of visits to...
Following the announcement late at night on March 12 that Bulgaria is about to declare national State of Emergency, the Bulgarian Drug Agency (BDA) also took measures in view of the current epidemiological situation in the state. Audiences and consultations will be done remotely and...
The Romanian ANMDMR (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale din Romania) announced on 12.03.2020 restrictions of the activity of their Registration Department. In view of the current epidemiological context and in order to avoid as much as possible any document related trips and...