State Expert Center of the Ministry of Health of Ukraine

Attention applicants! We continue implementing the provisions of European Union (EU) law (EU acquis) in the pharmaceutical sector

11.08.2023 4176

У зв’язку з проведенням порівняльного аналізу національної регуляторної системи у сфері обігу лікарських засобів в Україні в процесі об’єктивної оцінки діючої регуляторної системи…

Application intake for the seminar is closed!

09.08.2023 2105

Acceptance of applications for the seminar “Bioequivalence Studies in Detail. Biowaiver Based on the Biopharmaceutics Classification System”, which will take place on 12.09.2023, has ended. For…

Attention applicants! Information on the submission of updated registration documents

08.08.2023 4334

In accordance with Section VIII of the Procedure for Conducting Expert Evaluation of Materials on Medicinal Products Submitted for State Registration (Re-registration), as well as expert evaluation…

We invite applicants to take part in the survey on participation in the eCTD pilot project

07.08.2023 2319

The aim is to determine the level of readiness to participate in the pilot project. The survey will last until 10 August. The Center continues active work on…

Enrollment for the group “Bioequivalence studies in detail. BIOWAIVER BASED ON THE BIOPHARMACEUTICS CLASSIFICATION SYSTEM”

04.08.2023 2140

The Agency for Methodological and Scientific-Practical Work of the Center announces enrollment for the seminar “Bioequivalence Studies in Detail. BIOWAIVER BASED ON BIOPHARMACEUTICAL…

Group enrollment for the seminar “The Most Common Non-Conformities Identified During Audits of Applicants’ Pharmacovigilance Systems. An Example of Developing a Corrective and Preventive Action Plan”.

28.07.2023 2520

The Center's Agency for Methodological and Scientific-Practical Work informs about the enrollment of a group for the seminar “The most common non-conformities identified during the audit of the system…

Attention applicants! The procedure for emergency state registration under martial law has been canceled – clarification from the Center

21.07.2023 3993

Dear applicants, please note that, in accordance with the Resolution of the Cabinet of Ministers of Ukraine of 4 July 2023 No. 673 “On…

Attention of applicants – we draw your attention to the need to correctly complete applications and registration forms

20.07.2023 4574

We draw applicants' attention to the need to correctly complete applications and registration forms, namely the sections “Active substance(s)” and “Qualitative and…

Enrollment is open for a seminar on targeted audit of the applicants’ pharmacovigilance system. Approximate date – June 26, 2023

12.06.2023 1986

The Agency for Methodological and Scientific-Practical Work of the Center is launching a series of training seminars on pharmacovigilance. The first of them is already on June 26…

ATTENTION LABORATORIES!

29.05.2023 4435

The State Enterprise “State Expert Center of the Ministry of Health of Ukraine” announces an extension of the deadline for the annual selection of laboratories for authorization to conduct…

Attention applicants! We continue implementing the provisions of European Union (EU) law (EU acquis) in the pharmaceutical sector

Application intake for the seminar is closed!

Attention applicants! Information on the submission of updated registration documents

We invite applicants to take part in the survey on participation in the eCTD pilot project

Enrollment for the group “Bioequivalence studies in detail. BIOWAIVER BASED ON THE BIOPHARMACEUTICS CLASSIFICATION SYSTEM”

Group enrollment for the seminar “The Most Common Non-Conformities Identified During Audits of Applicants’ Pharmacovigilance Systems. An Example of Developing a Corrective and Preventive Action Plan”.

Attention applicants! The procedure for emergency state registration under martial law has been canceled – clarification from the Center

Attention of applicants – we draw your attention to the need to correctly complete applications and registration forms

Enrollment is open for a seminar on targeted audit of the applicants’ pharmacovigilance system. Approximate date – June 26, 2023

ATTENTION LABORATORIES!

Forum "PHARMEXPERT 2026: pharmaceutical market in the new regulatory reality"

Forum "Clinical and preclinical studies in wartime: organization and development prospects"

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

PHARMEXPERT 2024. Standards. Innovations. European integration

Announcements

Attention applicants! We continue implementing the provisions of European Union (EU) law (EU acquis) in the pharmaceutical sector

Application intake for the seminar is closed!

Attention applicants! Information on the submission of updated registration documents

We invite applicants to take part in the survey on participation in the eCTD pilot project

Enrollment for the group “Bioequivalence studies in detail. BIOWAIVER BASED ON THE BIOPHARMACEUTICS CLASSIFICATION SYSTEM”

Group enrollment for the seminar “The Most Common Non-Conformities Identified During Audits of Applicants’ Pharmacovigilance Systems. An Example of Developing a Corrective and Preventive Action Plan”.

Attention applicants! The procedure for emergency state registration under martial law has been canceled – clarification from the Center

Attention of applicants – we draw your attention to the need to correctly complete applications and registration forms

Enrollment is open for a seminar on targeted audit of the applicants’ pharmacovigilance system. Approximate date – June 26, 2023

ATTENTION LABORATORIES!

Forum "PHARMEXPERT 2026: pharmaceutical market in the new regulatory reality"

Forum "Clinical and preclinical studies in wartime: organization and development prospects"

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

PHARMEXPERT 2024. Standards. Innovations. European integration