Reflections from BADI’s 15th Anniversary The 15th anniversary of the Bulgarian Association for Drug Information (BADI) was more than a celebration of history. It was a forward-looking discussion about the future of regulatory affairs, the pharmaceutical industry and market access in Europe. Bringing together regulators, experts...
PharmDedict proudly represents Bulgaria & Romania in the EuDRAcon family - the European Drug Regulatory Affairs Consultants Network. EuDRAcon covers 30+ countries, including all EU member states, Norway, Switzerland, and Liechtenstein. Every member is selected based on proven regulatory expertise, reliability, and responsiveness. Founded in 2007,...
In the dynamic world of pharmaceuticals, regulatory affairs (RA) play a critical role in ensuring that products meet all necessary legal and safety requirements before reaching the market. However, with the complexity of regulations and the ever-changing global landscape, RA departments are facing increasing challenges....
On May 20, 2024 the Romanian Drug Agency posted an announcement about the necessity to amend the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) regarding the waste management of unused and/or expired medicines from the population, as follows: Annex 1 (PIL) to...
Have you ever struggled with the local adaptation and approval/notification of promo materials for medicinal products? If yes, then you know it could be challenging and you might be interested to see our successful experience with promotional materials in Bulgaria. The legal provisions that contain guidelines...
Regulatory Intelligence, as a systematic approach, includes the processes of regularly and proactively collecting regulatory information and analysing the latest updates that impact the operations of an organization. Regulatory Intelligence helps companies cope with the dynamics in regulations, accommodate changes, and ensure compliance. On February 23,...
A Transfer of Marketing Authorisation (MA) is the formal process for medicinal products through which the MA shifts from the current approved Marketing Authorisation Holder (MAH) to a new MAH, which is a distinct legal entity. This transfer may be prompted by a strategic decision...
In the fast-paced world and dynamic environment of a Pharma Company where critical business processes demand constant attention, the Regulatory Affairs (RA) Managers often find themselves facing a dilemma, especially in the holidays season, but not only...
At PharmDedict, we firmly believe in nurturing our team's talents to achieve excellence. We understand that our people are critical to our success, and that's why we're committed to finding, engaging, and growing the best talent. With a strong focus on local expertise, we recognize...
The Bulgarian Drug Agency (BDA) officially joined the PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme as its 55th Participating Authority, effective from July 1, 2023. PIC/S is a non-binding co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of...