The State Expert Center is developing amendments to the procedure for conducting clinical trials. The updated rules take into account the requirements of the EU Regulation, the provisions of the new Law "On Medicinal Products" and are part of the preparations for the launch of the Ukrainian Pharmaceutical Agency.
This is strategically important, as Ukraine is fully transitioning to the European model of clinical trial regulation. Timely changes will help businesses adapt to the new conditions, avoid technical failures and preserve the country's investment attractiveness for international partners.
To ensure the transition takes place without barriers or risks for the market, the Center held an online meeting with representatives of the MoH, member companies of the European Business Association (EBA), the Ukrainian Association of Clinical Research (UACR) and contract research organizations.
The parties discussed practical issues of implementing the new changes. Among them:
- submission of documents by applicants through the MoH Single Window;
- updated requirements for the labelling of investigational medicinal products;
- preparation of materials on substantial amendments;
- optimization of the Center's digital services.
The State Expert Center emphasized that successful preparation for the reform is a shared responsibility. Only through open dialogue, the involvement of all market participants and the development of joint solutions can a simple, safe and effective system of clinical trials be created in Ukraine.
