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Health Care, Clinical Trials

01/ 11/ 2017

Owing to the effective collaboration with the State Expert Center of the Ministry of Health of Ukraine the proposal of the EBA Clinical Trials Subcommittee regarding updating the Clinical Trials Guidelines[1] in accordance with the international standards has been considered and adopted.

Starting from 2016 the EBA repeatedly brought to the attention of clinical trials state authorities the issue of compliance with international standards and the need to update the domestic regulation. This need arose as the European Guideline for Good Clinical Practice (ICH GCP) has been amended in 2016[2]. The main innovations of the Guideline are:

  • encourage implementation of improved trials and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while trials continuing
  • ensure human subject protection and reliability of trial results
  • renewal of electronic records and essential documents intended to increase clinical trial quality and efficiency.

The EBA expresses its gratitude to State Expert Center for the elaboration and adoption of this important bylaw. We hope that this initiative will serve as a next step forward to improve scientific and research industry’s conditions in Ukraine, which will increase access to a high-quality and innovative treatment for patients.

The EBA looks forward to the publishing of the Clinical Trials Guideline on the official sources.

[1] The Order of the Ministry of Health of Ukraine No. 95 as of February 16, 2009 (amended by MOH Order No. 1169 as of September 26, 2017), approved the Guidelines “Medicines. Good Clinical Practice. ST-N MOHU 42-7.0: 2008 “, to replace the manual 42-7.0: 2005” Medicines. Good Clinical Practice “.

[2] The International Good Clinical Practice Guide (GCP) was amended by the new INTEGRATED ADDENDUM TO ICH E6 (R1) GUIDELINE FOR GOOD CLINICAL PRACTICE E6 (R2) as of 9 November 2016.

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