State Expert Center of the Ministry of Health of Ukraine

On confirmation of the authority of representatives when declaring the wholesale selling price of a medicinal product

04.04.2025 8302

Для декларування оптово-відпускної ціни на лікарський засіб власник реєстраційного посвідчення на лікарський засіб (або власник дозволу на паралельний імпорт лікарського…

ATTENTION! On 07 March 2025, a webinar "Meeting with members of ethics commissions" will be held.

25.02.2025 2865

The State Expert Center of the Ministry of Health of Ukraine invites members of ethics committees to a free online meeting. The event will be conducted by specialists of the Department of Expert Evaluation…

For applicants' attention!

10.02.2025 5973

The State Expert Center of the Ministry of Health of Ukraine (hereinafter – the Center) considers it necessary to inform about the need to comply fully with the requirements established…

For applicants' attention!

03.02.2025 3403

The State Expert Center of the Ministry of Health of Ukraine (hereinafter – the Center) considers it necessary to inform about the need to comply fully with the requirements established…

On amendments to the organization of contractual work with 03.02.2025

23.01.2025 3154

In order to establish uniform requirements for the organization of records management, in particular the procedure for forming files, ensuring their registration, prompt search by content and…

ATTENTION APPLICANTS, MEDICINAL PRODUCT DEVELOPERS, RESEARCHERS!

17.12.2024 3845

Harmonization of Bioequivalence Standards: A Step Forward with ICH M13A On January 25, 2025, the guideline on demonstrating bioequivalence ICH M13A will come into force…

ATTENTION APPLICANTS, MEDICINAL PRODUCT DEVELOPERS, RESEARCHERS!

19.11.2024 2317

In Ukraine, the guideline “Medicinal products. Clinical trials of medicinal products for the treatment of arterial hypertension” has entered into force. In order to harmonize the regulatory framework…

To the attention of investigators, sponsors of clinical trials, applicants, manufacturers of medicinal products and other interested parties.

19.11.2024 2926

In order to harmonize the regulatory framework in Ukraine regarding the content and scope of the Dossier of an investigational advanced therapy medicinal product (hereinafter…

ATTENTION APPLICANTS, MEDICINAL PRODUCT DEVELOPERS, RESEARCHERS!

06.11.2024 2412

The guideline “Medicinal Products. Preclinical Biodistribution Studies of Gene Therapy Medicinal Products (Products)” has come into force in Ukraine. In order to harmonize the regulatory and legal framework…

PHARMEXPERT 2024. Standards. Innovations. European integration

22.10.2024 2083

Dear colleagues! We are pleased to invite you to take part in the large-scale pharmaceutical forum "PHARMEXPERT 2024. Standards. Innovations. European Integration", which will take place on 21 November…

On confirmation of the authority of representatives when declaring the wholesale selling price of a medicinal product

ATTENTION! On 07 March 2025, a webinar "Meeting with members of ethics commissions" will be held.

For applicants' attention!

For applicants' attention!

On amendments to the organization of contractual work with 03.02.2025

ATTENTION APPLICANTS, MEDICINAL PRODUCT DEVELOPERS, RESEARCHERS!

ATTENTION APPLICANTS, MEDICINAL PRODUCT DEVELOPERS, RESEARCHERS!

To the attention of investigators, sponsors of clinical trials, applicants, manufacturers of medicinal products and other interested parties.

ATTENTION APPLICANTS, MEDICINAL PRODUCT DEVELOPERS, RESEARCHERS!

PHARMEXPERT 2024. Standards. Innovations. European integration

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

On confirmation of the authority of representatives when declaring the wholesale selling price of a medicinal product

ATTENTION! On 07 March 2025, a webinar "Meeting with members of ethics commissions" will be held.

For applicants' attention!

For applicants' attention!

On amendments to the organization of contractual work with 03.02.2025

ATTENTION APPLICANTS, MEDICINAL PRODUCT DEVELOPERS, RESEARCHERS!

ATTENTION APPLICANTS, MEDICINAL PRODUCT DEVELOPERS, RESEARCHERS!

To the attention of investigators, sponsors of clinical trials, applicants, manufacturers of medicinal products and other interested parties.

ATTENTION APPLICANTS, MEDICINAL PRODUCT DEVELOPERS, RESEARCHERS!

PHARMEXPERT 2024. Standards. Innovations. European integration

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