The International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use was established in 1990.
It brings together regulatory authorities and the pharmaceutical industry of the world to discuss aspects of medicinal product registration, develop guidelines and provide recommendations to achieve greater harmonization in the interpretation and application of the relevant technical requirements.
The Center uses current ICH guidelines when participating in the development of national regulations and has many years of experience in conducting expert evaluation of registration materials and clinical trial materials of medicinal products in accordance with ICH approaches and recommendations.
In 2021, the Center initiated stronger cooperation and obtained the official status of Observer at the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (SECMOH, Ukraine). The Center's representative at ICH is Mykhailo Babenko.
"Our new role has sent a clear signal to the whole world that the State Expert Center and the Ministry of Health are making every effort to guarantee Ukrainian citizens the highest global standards of safety, efficacy, and quality of medicinal products," commented the director on strengthening cooperation with ICH.
In 2022, as part of the implementation of the eCTD format in Ukraine, the Center initiated cooperation in the ICH working group (M8) dealing with the electronic common technical document (eCTD). In 2023, a representative of the Center was included in the M8 working group, M2 EWG subgroup, and is currently actively gaining experience regarding future eCTD changes that will be introduced.
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