The simplification of the registration process for medicines produced from domestically sourced active pharmaceutical ingredients (APIs), as outlined in the government’s Action Plan, will serve as an incentive for the development of API production, but will require a clearly defined implementation mechanism, according to CEO of the Interchem pharmaceutical company Anatoliy Reder.
"If such an initiative is indeed implemented, it will be very important for us, and we are firmly in favor of it. I don’t yet fully understand exactly how this will be implemented, as there needs to be a transparent and clear regulatory mechanism. It’s not enough to simply say, "Let"s support manufacturers of finished pharmaceutical products that use APIs produced in Ukraine’; we need to develop and establish a clear algorithm," he said in an interview with Interfax-Ukraine.
According to Reder, the development and implementation of such a mechanism will serve as a powerful incentive for Ukrainian manufacturers to develop local production of active pharmaceutical ingredients and expand the range of finished pharmaceutical products manufactured using Ukrainian APIs.
He said that currently, over 70% of Interchem’s finished drug production is covered by active pharmaceutical ingredients manufactured by the company itself. In addition, Interchem uses active pharmaceutical ingredients produced by Pharmchem (Shostka, Sumy region).
In total, about 80% of Interchem’s medicines are manufactured using Ukrainian active pharmaceutical ingredients.
