The Council of the Eurasian Economic Commission has made amendments to the Rules for Conducting Research on Biological Medicines of the Eurasian Economic Union, approved by the Decision of the EEC Council dated November 3, 2016 No. 89.
The changes affected chapters “31. Quality, preclinical and clinical aspects of development and study of medicinal products based on human somatic cells” and “32. Quality, preclinical and clinical aspects of development and study of medicinal products containing genetically modified cells”.
This Decision shall enter into force on 26 March 2025.
The full text of the document can be found on the portal: https://pharmnewskz.com/ru/legislation/reshenie-eek-13-ot-22-yanvarya-2025-g_10173
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
The changes affected chapters “31. Quality, preclinical and clinical aspects of development and study of medicinal products based on human somatic cells” and “32. Quality, preclinical and clinical aspects of development and study of medicinal products containing genetically modified cells”.
This Decision shall enter into force on 26 March 2025.
The full text of the document can be found on the portal: https://pharmnewskz.com/ru/legislation/reshenie-eek-13-ot-22-yanvarya-2025-g_10173
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz