Pharmaceutical forum "PHARMEXPERT 2025. eCTD and pricing in Ukraine – a strategic path to integration into the international regulatory space"

• UA
• EN

RESOLUTION

Pharmaceutical Forum with international participation "PHARMEXPERT 2025. eCTD AND PRICING IN UKRAINE – A STRATEGIC PATH TO INTEGRATION INTO THE INTERNATIONAL REGULATORY SPACE"

On 17 June 2025, a pharmaceutical forum with international participation, "PHARMEXPERT 2025. eCTD and Pricing in Ukraine – a Strategic Path to Integration into the International Regulatory Space," took place in Kyiv. The event was organized by "Proxima Research International" in cooperation with the State Expert Center of the Ministry of Health of Ukraine with the support of the Ministry of Health of Ukraine and the information partner "Weekly APTEKA."

The Forum became an open professional platform for discussing two key aspects of the transformation of Ukraine's pharmaceutical sector: the introduction of the international eCTD format for the registration of medicinal products and the establishment of transparent drug pricing.

More than 300 participants took part in the event, in both offline and online formats, including leading healthcare experts, representatives of state and executive authorities, the pharmaceutical business, the scientific community, and professional and patient organizations. International experts from WHO, regulatory authorities of the Republic of Croatia, the Republic of Poland, the Republic of Moldova, the Kingdom of Denmark and the Portuguese Republic, the USAID/SAFEMed project, the London School of Economics, and the companies EXTEDO GmbH and Lorenz Life Sciences also joined, which gave the event particular weight and value.

The Forum consisted of two sessions and four panel discussions. As part of the program, participants discussed: international experience in implementing eCTD, using EU countries as an example; the regulatory framework and practical issues of eCTD in Ukraine; the policy, mechanisms, and tools of medicinal product pricing; and the availability of medicines for patients.

Forum participants emphasized the need and readiness to continue joint work to achieve Ukraine's European integration goals in the pharmaceutical sector and adopted the following key proposals:

On the implementation of the international eCTD format

1. The introduction of the international eCTD format as the new standard for submission of registration materials for medicinal products was confirmed, in line with the requirements of the Law of Ukraine "On Medicinal Products" No. 2469-IX of 28 July 2022 and the European integration vector of the development of Ukraine's pharmaceutical sector.
2. It was noted that applicants need to prepare the appropriate technical and staffing infrastructure for the transition to submitting registration materials for medicinal products in eCTD format.
3. Forum participants emphasized the advisability of:
   • Unification of the procedure for submitting registration materials for medicinal products in eCTD format in line with EU practice – the application and the registration dossier materials at the same time.
   • Amending regulatory legal acts to define the deadlines and procedure for submitting registration dossier materials for medicinal products in eCTD format for all registration procedures (registration, re-registration, variations).
   • Considering the possibility of partially retaining the paper form of submission of registration materials for medicinal products to support small domestic manufacturers, following the example of the Republic of Poland.

On the reform of medicinal product pricing

1. It was noted that, as part of the Government's overall strategy to ensure the availability of medicinal products for Ukrainians and to bring the pharmaceutical market in line with the standards of EU member states, a comprehensive reform of medicinal product pricing is under way in Ukraine.
2. The importance of a systematic and integrated pricing policy was emphasized for medicinal products in order to ensure the affordability of medicines for all population groups and the stability and effective functioning of Ukraine's pharmaceutical market.
3. The advisability of applying differentiated approaches has been determined to the reference pricing methodology for original and generic medicinal products:
   • For original medicinal products – external reference pricing based on the prices from a defined basket of reference countries.
   • For generic medicinal products – internal reference pricing, taking into account high market competition and the availability of numerous alternatives.
4. Forum participants emphasized the advisability of:
   • Ensuring consistency and integrity between existing market regulation instruments.
   • Expansion of state programs (reimbursement, centralized and decentralized procurement, managed access agreements). After all, the price of a medicinal product is not only its cost but also its availability, which can be ensured by state programs, which in turn will help reduce the financial burden on patients.
   • Orientation of pricing policy toward the principles of patient-centeredness with an emphasis on transparency and clarity in the formation of medicine prices.
5. Forum participants support:
   • Creation and use of the National Catalog as a tool for transparent regulation of medicinal product prices.
   • Conducting an assessment of the results of the first and subsequent stages of the pricing reform and implementing appropriate improvements, including taking into account international experience.
   • Digitalization of pricing processes to improve the quality of regulation and the effectiveness of monitoring and control.
   • Further expansion of reimbursement instruments, in particular the "Affordable Medicines" program, as this is a critically important step in ensuring patients' access to effective and timely treatment.

Forum participants draw attention to the advisability of taking into account the expert input of the Forum when developing by-laws and other regulatory documents in the area of medicinal product pricing policy, as well as the further digitalization of the healthcare sector.

Final provisions

The Forum Organizing Committee expresses its sincere gratitude to all participants for their active professional cooperation, constructive discussions, and practical proposals.

The Forum confirmed that open dialogue and meetings in this format are an important step toward a deeper understanding of new reforms and regulatory requirements; promote effective cooperation among public authorities, business, international partners, the expert community, and public and patient organizations; and ensure the further development of healthcare in Ukraine.

The Resolution was adopted as a basis and, on the instruction of the Forum, finalized and approved by the Forum Organizing Committee.

Organizing Committee
of the Pharmaceutical Forum "PHARMEXPERT 2025. eCTD and Pricing in Ukraine – a Strategic Path to Integration into the International Regulatory Space"

Kyiv, June 27, 2025

FORUM MATERIALS

• Landing page
• Information about the Forum
• Forum Program