Due to Digital Technologies Darnitsa Will Reduce the Time of Release of New Medicinal Products16 February 2021
By the end of 2021 Darnitsa plans to launch more than 25 new pharmaceutical brands, with a total of 50 products. Due to the company's transition to digital technologies, every fourth one of these products will appear on pharmacy shelves 2 months ahead of schedule.
Timely investments of about UAH 100 million and the early start of digital transformation projects have positively influenced the efficiency of the process of registration and introduction of changes to drug dossiers and minimized the risks caused by quarantine restrictions. In 2020, Darnitsa received a new registration of medicines every two weeks and re-registered its own products in Ukraine every week.
Oleksandr Torhun, Regulatory Affairs Director: “We managed to achieve an increase in efficiency in the regulatory area due to the focus on the world’s best practices, constant search for and implementation of the most advanced ideas. Darnitsa’s priority is the patient and we do our best to ensure the maximum level of quality and safety of our products.”
Darnitsa was the first one among pharmaceutical companies in Ukraine to start studying the effect of digital technologies on accelerating the release of new products and increasing the accessibility of medicines. According to Oleksandr Torhun, Darnitsa already uses a fully digital dossier, switched to electronic monitoring of the use of medicines and started using electronic master files (eTMF) in the process of clinical studies.
“Digital innovations stabilize the work of the regulatory service and reduce the impact of risk factors caused by the lockdown. In 2020, we registered 24 new drugs, 55 drugs were re-registered, and 350 changes were made to marketing authorizations. We got approved 90 procedures in 16 countries, which is also the result of digital interaction and allows the company to focus on expanding its presence in foreign markets”, Director of the Regulatory Affairs Department of Darnitsa reported.
The company emphasizes that due to the transformation of the regulatory department and new digital platforms they managed to finish clinical studies under extremely difficult conditions and accelerated the process of launching of 10 new products.
“Now new drugs appear on pharmacy shelves sooner and are often a more affordable alternative for Ukrainians than foreign drugs”, - Oleksandr Torhun notes.