Hi all,
Is there any specific Russian guideline or regulatory document addressing the management of NAs?
If not, which reference document is typically used in Russia? Does Russia follow the EMA Q&A on this topic, or is there an alternative guidance document?
Many thanks.
@Khilola_SCD Do you have any insight into this? Thx
Hello, Sara! In Russia, there is a GUIDELINE for the control of N-nitrosamine impurities, developed by the Ministry of Health and the Scientific Centre for Expert Evaluation of Medicinal Products.
https://pharmacopoeia.regmed.ru/upload/iblock/2ea/e8bwdrd19mjgfc9sy4ciqvrnun3tcwkh.pdf
Dear Razvedosa
Thank you for sharing the reference document; it is very helpful and appreciated.
That said, I would like to point out that the Nitrosamines guideline does not appear to provide specific details regarding the Step 2 confirmatory testing requirements. In particular, we could not identify clear expectations related to the analytical and control strategy, such as LOD setting, batch variability considerations, or the number and selection of batches to be tested.
Could you please indicate whether, for this aspect, we may apply the requirements and expectations outlined by other HAs (e.g. EMA, FDA, etc) when defining the analytical and control strategy?
For example, whether principles such as:
omission of testing when the NA/NDSRI level is below 10% of the AI,
skip testing when the level is between 10% and 30% of the AI,
or other risk-based testing approaches
would be considered acceptable in this context.
Thank you in advance for your guidance.
Kind regards,
Russia guideline is not up to date as per the current knowledge available with various regulatory agencies. Generally, Russia recommends following BP/EP & hence for any additional information on NA we can follow EMA guidelines.
Great. Thank you for the help 
Hello
EAEU Decision No. 78 (Rules of Registration and Examination of Medicinal Products) requires applicants to follow internationally recognized approaches for impurity assessment and control, including ICH principles. https://eec.eaeunion.org/upload/medialibrary/112/3-Decision-78-June-30_-2017_Requirements-to-the-Electronic-Form-of-Applications-and-Documents.docx
In 2022, the Eurasian Economic Commission adopted requirements for the assessment and control of impurities in medicinal products, establishing harmonized approaches for impurity qualification and safety evaluation across EAEU member states.
The EAEU Pharmacopoeia provides the analytical framework for impurity testing, but currently does not contain a dedicated nitrosamine guideline.
This is not true. Russia develops its guidelines and pharmacopoeial monographs based on current regulations of the Ph. Eur., FDA, USP, and ICH.
The Eurasian Economic Commission and authorized bodies of the Eurasian Economic Union countries will be guided by the World Health Organizationβs approaches at all key stages of the medicinal products regulationβfrom preclinical trials and registration to pharmacovigilance, inspections, and state control. The corresponding decision was made by the Council of the Eurasian Economic Commission on July 9.