ATTENTION TO MEDICINAL PRODUCT DEVELOPERS, RESEARCHERS, APPLICANTS!

In Ukraine, the guideline СТ-Н МОЗУ 42 – 7.13:2024 "Guideline. Medicinal products. Requirements for documentation on chemical and pharmaceutical quality of medicinal products within clinical trials", approved by order of the Ministry of Health of Ukraine dated 14.06.2024 No. 1028, has entered into force.

The guideline sets out provisions on special requirements for documentation on the chemical and pharmaceutical quality of investigational medicinal products (IMPs) submitted to obtain authorisation to conduct a clinical trial/study or notification of substantial amendments to the Investigational Medicinal Product Dossier (IMPD) to the competent authority of Ukraine.

Since clinical trials are often planned as multicentre studies involving different EU Member States, the purpose of this Guideline is to define harmonised requirements for the documentation accompanying clinical trials/studies of medicinal products in Ukraine and the countries of the European Union.

To ensure that the manufacture of investigational medicinal products complies with the principles and guidelines of good manufacturing practice, to ensure consistent quality production from batch to batch of an investigational medicinal product used in one or different clinical trials, and to ensure adequate documentation and justification of changes during the development of an investigational medicinal product, it is necessary to introduce in Ukraine a guideline containing recommendations harmonized with the provisions of the relevant EU guideline and updated regarding the content and scope of the Investigational Medicinal Product Dossier.

The legal force of this guideline corresponds to the legal force of the relevant guidelines in the EU and other ICH countries with which the developed guideline has been harmonised. This guideline should be regarded as a technical document for providing advice to applicants and holders of registration certificates, competent authorised bodies and/or other interested parties on the best and most acceptable way of complying with the provisions established by the pharmaceutical legislation of Ukraine. The provisions of this guideline reflect a harmonised (within the EU and ICH) approach; they are based on the latest scientific advances in this field of knowledge.

The guideline contains provisions that comply with the current legislation of Ukraine: Articles 6, 7, 8 of the Law of Ukraine "On Medicinal Products", the "Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials and the Model Regulation on Ethics Committees", the Good Manufacturing Practice Guideline and the Good Clinical Practice Guideline.

Within the framework of the current legislation, the Guideline is advisory in nature. The developers envisage that the Guideline will be applied by business entities engaged in the development, preclinical and clinical study, and submission of applications for conducting clinical trials/studies of medicinal products in the territory of Ukraine, regardless of departmental subordination and form of ownership, by scientific and expert organizations and experts conducting expert evaluation of clinical trial/study materials, as well as by auditors and inspectors conducting audits of clinical trials/studies of medicinal products. Compliance with its provisions by interested parties (such as applicants, holders of registration certificates, developers and manufacturers of medicinal products, expert and regulatory authorities) will enhance the safety of conducting clinical trials, contribute to the improvement of documentation on the quality of investigational medicinal products, and accelerate the introduction of new medicinal products into medical practice.

We invite stakeholders to review the content of the Guideline posted on the official website of the State Expert Center of the Ministry of Health of Ukraine under the heading "Regulatory Legal Acts" – "Guidelines" at the link https://www.dec.gov.ua/materials/nastanovi/.