The strategy of European integration of the pharmaceutical industry is being gradually implemented in Ukraine: how Arterium got involved

One of the components of the strategy of the European integration of the pharmaceutical industry of Ukraine is the creation of a new unified authority for the state control of medicinal products, which will implement the state policy regarding the development of medicinal products, their launch onto the market and control of their quality, safety and efficacy.

The World Health Organization has developed recommendations for proper regulatory practice in the regulation of medicinal products. These documents are relevant and necessary in the creation of a new state control authority in our country.

In the context of preparation for these changes, Arterium Corporation has prepared a translation of the WHO recommendations "Good Regulatory Practice in the Regulation of Medicinal Products" of 2021.

The Ukrainian translation of this text has been made under the WHO CC BY-NC-SA 3.0 license.

These recommendations will allow Ukrainian regulators and specialists to get familiar with international experience and use it to organize such work in Ukraine, in particular, when preparing draft statutory documents, policies, procedures and instructions of a new state control authority.