Darnitsa digitalizes its pharmacovigilance system to meet the requirements of foreign regulators
Darnitsa pharmaceutical company is developing its pharmacovigilance system, its digitalization allowing the company to meet the modern requirements of foreign regulators, said Head of the Department for Regulatory Issues of Darnitsa Oleksandr Torhun.
‘The modern system of pharmacovigilance will allow Darnitsa in the long term to successfully meet the demands of those regulators that require more extensive data for registration dossiers. In fact, we are proactive in this case. After all, the capabilities of the new system are much wider than the classic format of pharmacovigilance,” the press service of the company quotes Torhun.
According to him, “pharmacovigilance in Ukraine is still slightly behind the regulators of the leading countries of the world,” while the regulatory policy of Ukraine is based on the European legislation and is largely harmonized with it, which simplifies the entry of Ukrainian drugs into the EU markets.
At the same time, Torhun noted that the European Medicines Agency (EMA), which assesses medicinal products for their compliance with the requirements set out in the European Pharmacopoeia is one of the regulators that impose increased requirements to the companies wishing to register their drugs. The USA, Canada, Japan, Australia, Switzerland also apply similar practice.
“These states carefully monitor the collection and analysis of data on adverse drug reactions, therefore, a competent and comprehensive approach to the collection of such data is mandatory for any pharmaceutical manufacturer if one wants to sell drugs in these countries,” Torhun said.
He noted that in VigiBase which is the WHO global database of individual case safety reports, “the signal detection process must rely on a combination of computerized data analysis methodology for the selection of combinations of ‘medicinal product – adverse reaction’, with the subsequent clinical evaluation reports by members of the medical and scientific group.”
With the support of this global network, 140 member countries of the Program for International Drug Monitoring, including Ukraine, as well as 30 affiliated countries, submit their reports on suspected adverse drug reactions to the VigiBase database. The repository of the database of reports in 2019 consisted of more than 20 million reports.
“We don't have any difficulties with foreign regulators. This whole process is now more or less standardized in the world in order to ensure a full and efficient exchange of data between countries,” he said.
At the same time, Torhun stressed, “the world is actively discussing new opportunities for collecting data for pharmacovigilance.”
“There are various projects that may become a common norm in the world and in Ukraine in the near future. For example, the collection of data on adverse drug reactions via social networks, Facebook and Twitter, in particular. Such approaches will greatly simplify the collection of information and filing of applications, increasing the role of the patient in pharmacovigilance even more,” he said.
Torhun reminded that export is an important component of Darnitsa's strategy. In particular, the company currently has about 400 registration dossiers in the foreign markets; the drugs are available in the markets of 15 countries of the world.