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:
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.