Attention medicinal product developers, researchers, and applicants! The guideline ST-N MOZU 42 – 7.13:2024 “Guideline. Medicinal Products. Requirements for Documentation on the Chemical and Pharmaceutical Quality of Medicinal Products in Clinical Trials,” developed by specialists of the State Expert Center and approved by the MoH order of 14.06.2024 No. 1028, has come into force in Ukraine.
The guideline defines provisions on special requirements for documentation on the chemical and pharmaceutical quality of investigational medicinal products (IMPs) submitted to the authorized body of Ukraine for obtaining authorization to conduct a clinical trial/study or for notification of substantial changes in the Investigational Medicinal Product Dossier (IMPD).
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 compliance of the manufacture of investigational medicinal products with the principles and guidelines of good manufacturing practice, to ensure consistent quality of production from batch to batch of an investigational medicinal product used in one or in different clinical trials, and to ensure adequate documentation and justification of changes during the development of an investigational medicinal product, the guideline contains recommendations, harmonized with the provisions of the relevant EU guideline and updated, on the content and volume of the dossier of an investigational medicinal product.
The legal force of the guideline corresponds to the legal force of the relevant guidelines in the EU and other ICH countries with which it is harmonized.
The guideline should be regarded as a technical document for providing advice to applicants and registration certificate holders, competent authorized bodies, and/or other interested parties on the best and most acceptable way to comply with the provisions established by the pharmaceutical legislation of Ukraine. The provisions of this guideline reflect a harmonized (within the EU and ICH) approach and are based on the latest scientific achievements 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.
Under current legislation, the guideline is of a recommendatory nature. It is valuable for business entities engaged in the development, preclinical and clinical study, and submission of applications for clinical trials/studies of medicinal products in the territory of Ukraine, regardless of departmental subordination and form of ownership; for scientific expert organizations and experts who conduct the expert evaluation of clinical trial/study materials; and also for auditors and inspectors who audit clinical trials/studies of medicinal products. Compliance with its provisions by stakeholders (applicants, registration certificate holders, developers and manufacturers of medicinal products, expert and regulatory bodies) will increase the safety of clinical trials, contribute to improving the quality documentation of investigational medicinal products, and speed up the introduction of new medicinal products into medical practice.
You can familiarize yourself with the contents of the guideline at the link https://www.dec.gov.ua/materials/nastanovi/
