In Ukraine, a new edition of the guideline "Medicinal products. Good Clinical Practice (GCP) ICH E6 (R3). ST-N MoHU 42–7.18:2025" has come into force, replacing the guideline "Medicinal products. Good Clinical Practice. ST-N MoHU 42–7.0:2008", approved by order of the Ministry of Health of Ukraine No. 95 of February 16, 2009.
With the aim of harmonizing the regulatory framework in Ukraine on clinical trials of medicinal products, on the basis of the European Union document: EMA/CHMP/ICH/135/1995 "ICH E6 (R3) Guideline for good clinical practice (GCP)" Step 5, 23 January 2025 [ICH E6 (R3) Guideline "Good Clinical Practice", step 5, dated 23 January 2025], specialists of the State Expert Center of the Ministry of Health of Ukraine have developed a new edition of the guideline "Medicinal products. Good Clinical Practice (GCP) ICH E6 (R3). ST-N MoHU 42–7.18:2025", approved by order of the Ministry of Health of Ukraine dated 05.11.2025 No. 1686 (hereinafter referred to as the Guideline), to replace the guideline "Medicinal products. Good Clinical Practice. ST-N MoHU 42–7.0:2008", approved by order of the Ministry of Health of Ukraine dated 16 February 2009 No. 95 (as amended by order of the Ministry of Health of Ukraine dated 04 May 2020 No. 1023), which applies to all types of medicinal products for human use and establishes general requirements for the planning, organization, conduct and documentation of the results of clinical trials of medicinal products for human use.
The Guideline addresses
- innovative provisions intended for application in various types and conditions of clinical trials;
- the "quality by design" (QbD) approach;
- the involvement of patients (patient organizations) in the development of trial design;
- additional clarifications on ensuring the integrity of digital data, cybersecurity and the possibilities of remote conduct of trials;
- principle on the distribution of roles and responsibilities within the quality management system;
- etc.
The text of the new edition of the document can be reviewed on the website of the State Expert Center of the Ministry of Health of Ukraine in the section "Audit Department", subsection "Legislation of Ukraine on preclinical and clinical trials" at the link
