News
EAEU clarified concepts of high-technology medicines for human use
The Eurasian Economic Commission's Council has amended the Rules for Marketing Authorization and Expert Examination of Medicines for Human Use.
The Rules for Marketing Authorization and Expert Examination are the most essential document in the field of medicines circulation. In this regard, the Rules are updated with the emergence of new groups of pharmaceuticals, research evidence in the field of pharmacology and pharmacy, as well as practices of Member States.
The Council's decision extended and harmonized the conceptual framework of the Rules of marketing authorization in relation to new groups of medicines based on high technologies. The decision identified three new groups of medicines: gene therapy products, somatic cell products, and tissue-engineered products.
Adoption of these amendments will allow to optimize the processes of brining a range of products to the market to employ breakthrough technologies in treating previously incurable human diseases.
