Simplified registration for medicines using domestically produced APIs requires clear implementation mechanism – opinion
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.
The government's Action Plan proposes to simplify the registration process for medicines made from domestically sourced active pharmaceutical ingredients (APIs) as an incentive for API production development, according to Anatoliy Reder, CEO of Interchem pharmaceutical company. Reder emphasized the necessity of a transparent and clear regulatory mechanism for the initiative's successful implementation.
He clarified that merely supporting manufacturers of finished pharmaceutical products using locally produced APIs is insufficient; a well-defined algorithm is essential. Reder highlighted that approximately 70% of Interchem's finished drug production currently relies on APIs manufactured within Ukraine, with Pharmchem (located in Sumy region) contributing further to this percentage, accounting for around 20%. Consequently, around 80% of Interchem's medicines are produced using Ukrainian APIs.
Written by urgent.news from Interfax-Ukraine's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
