The State Expert Center of the Ministry of Health of Ukraine has developed a guideline on clinical trials of medicinal products for the treatment and prevention of diabetes mellitus. The document was approved by MoH order No. 1469 of 22.09.2025 https://surl.li/tlsrvk
The guideline was developed on the basis of the European Medicines Agency guideline CPMP/EWP/1080/00 Rev. 2 Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus and adapted to the Ukrainian healthcare system. This reflects a harmonized approach to medicinal product development at the EU and ICH level, based on the latest scientific advances in the field of diabetes treatment.
Who is this guideline important for?
The guideline is recommended for:
- applicants and registration certificate holders;
- pharmaceutical companies engaged in the development and manufacture of medicines;
- of physician-researchers and scientific expert organizations.
Compliance with the provisions of the document will make it possible to improve the safety of clinical trials, ensure adherence to ethical principles, and accelerate the introduction of new effective medicinal products into practice.
Why is this important?
Diabetes mellitus is one of the most common chronic diseases in the world and in Ukraine. The development of modern medicinal products for the treatment and prevention of diabetes directly affects the quality and length of life of millions of patients.
Adoption of this guideline opens up new opportunities for the Ukrainian pharmaceutical sector:
- facilitates the development and registration of innovative medicines;
- creates conditions for Ukraine's participation in international clinical trials;
- brings Ukrainian standards closer to European ones, which is especially important on the path to EU integration.
Thus, the document is an important step toward harmonizing Ukraine's regulatory environment with EU standards and will open new prospects in the treatment of patients with type 1 and type 2 diabetes.
