18.Jan.2018

Nonclinical studies in the Russian Federation

In December 2017, EMWA's journal Medical Writing published an article by ОСТ’s preclinical project manager Anna Buryakina and medical writer Natalya Merkulova on nonclinical studies in Russia.

It covered issues, regulatory standards and harmonization with international standards.

In particular, the authors focused on legislative regulations, such as Federal Law No. 61-FZ dated April 12, 2010, which is the main document governing the circulation of medicines in Russia. Its Paragraph 11 defines the scope of nonclinical studies and requirements for their conduct. The authors stressed the importance of conducting nonclinical studies in compliance with GLP requirements which is a significant part of  the National Strategy for Development of the Pharmaceutical Industry (Pharma 2020). The article contains a mapping table showing the differences between the GOST requirements and their ICH counterparts.

The authors also considered the requirements of the Guidelines for Preclinical Trials of Medicinal Products and Federal Law no. 429-FZ and named some barriers to implementing the Guidelines, such as:

  • inconsistences in toxicity study designs,
  • insufficient supply of good-quality animals for nonclinical studies,
  • inconsistencies in terminology (‘preclinical’ vs. ‘nonclinical’ studies).

The positive aspect mentioned is that the Russian Federation is obviously beginning to understand that, without common standards, new treatments will not become available.

Source article is available at: Medical Writing, Volume 26, Number 4 (Preclinical studies). P. 33-37.