Ukraine has exclusively developed medicines, which will be registered by regulatory agencies of Europe and the United States, Director General of YURiA-PHARM pharmaceutical company Dmytro Derkach.
Commenting on the study of the data about the market of drugs with insufficient evidence base initiated by Anti Corruption Action Centre (AntAC) with the support of the International Renaissance Foundation last week, he told Interfax-Ukraine that “according to the logic of the authors of this study, only drugs originating from the countries with regulatory authorities FDA (the United States) or EMA (the European Union) have the “proven effectiveness,” that is, Ukraine has no right to own inventions and developments.”
“The authors reject the idea that Ukraine has its own scientific and industrial potential, which is also capable of giving the world original and effective medicines or methods of treatment, and with the assistance of the state, capable of registering its products with the FDA and EMA regulatory authorities. It takes time and resources. Ukraine chose the path of European integration only a few years ago,” he said.
Derkach said that YURiA-PHARM is currently “on the way to register their products in the FDA and EMA.” Reosorbilact preparation is the process of registration, which is mentioned in the research materials as a drug that is among the top ten in terms of pharmacy sales, but at the same time, according to the authors of the study, not having clinically proven effectiveness.
According to Derkach, Reosorbilact is the development of domestic scientists of the Lviv Research Institute of Blood Pathology and Transfusion Medicine of the National Academy of Medical Sciences of Ukraine. As an original drug, it was registered early 2000s, having passed all the phases of clinical trials in accordance with the current legislation and legal acts of Ukraine. It has become the basis of numerous scientific research and defending candidate and doctoral dissertations during the past years. Currently, it is registered in Uzbekistan, Tajikistan, Azerbaijan, Kazakhstan, Moldova and Kyrgyzstan, in most countries of the former CIS.
According to Derkach, “in fact, the authors of this study question the professional competence of the domestic scientific medical and pharmaceutical community.”
YURiA-PHARM Corporation is a manufacturer of infusion solutions, medicines and medical products. It is among top ten leaders in pharmacy sales.
YURiA-PHARM is a member of the Association Manufacturers of Medications of Ukraine (AMMU).