Changes have been developed to the Guidelines for Determining the Scope of Laboratory Tests in the Evaluation of Medicinal Products
The draft Recommendation of the Board of the Eurasian Economic Commission “On Amendments to the Guidelines for Determining the Scope of Laboratory Tests in the Examination of Medicinal Products” has been submitted for public discussion and published on the EEC legal portal.
The changes are planned to be made to the Guidelines approved by Recommendation No. 28 of the EEC Board dated September 10, 2019, “On the Guidelines for Determining the Scope of Laboratory Tests in the Examination of Medicinal Products.”
The document aims to standardize the approaches of the authorized bodies of the EAEU member states to the scope of testing of drug samples. This applies to procedures for registration, confirmation of registration, and amendments to the registration dossier.
The main changes relate to clarifying the criteria for classifying changes in the composition of excipients as minor, which simplifies the procedure for making changes to a drug. In particular, for solid, soft, and liquid dosage forms, the permissible percentage deviations in mass for different types of excipients, such as fillers, disintegrants, and binders, are now clearly specified. For example, the total change in all excipients should not exceed 10% of the mass of the tablet or capsule core.
In addition, the draft clarifies the cases when the provision of samples and reagents is not required, and laboratory tests are conducted in accordance with the Registration Rules. Changes are also being made to the testing requirements when analytical methods and drug specification parameters are changed.
If approved, the Recommendation will come into force 30 calendar days after its official publication. Public discussion will continue until October 18, 2025.
https://regulation.eaeunion.org/pd/3214/
September 30, 2025
Rules for the destruction of methanol and methanol-containing liquids have been prepared
The Ministry of Industry and Trade has developed rules for the destruction of methanol and methanol-containing liquids. The draft resolution of the Government of the Russian Federation “On the Approval of Rules for the Destruction of Methanol and Methanol-Containing Liquids” is undergoing public discussion until October 2, 2025.
According to the draft rules, methanol must be destroyed by organizations and individual entrepreneurs whose information is included in the relevant register. Exceptions are scientific organizations and universities where methanol is used in research, development, and technological work. Organizations in the defense industry are also exempt.
According to the document submitted for consideration, methanol and methanol-containing liquids are destroyed in compliance with the requirements of SP 2.2.5.4116-25 “Sanitary and epidemiological requirements for the organization and conduct of work with methanol” and GOST 2222-95 “Technical Methanol,” and thermal, chemical, biological, and other methods of destruction are used in accordance with GOST 2222-95 “Methanol. Technical Conditions.” Persons aged 18 and older who have undergone training and instruction are allowed to destroy methanol.
If approved, the document will come into force on March 1, 2026, and will remain in effect until March 1, 2032.
Link: https://regulation.gov.ru/projects/160486/
September 23, 2025
Changes have been made to the fees for conducting pharmaceutical inspections
On September 15, 2025, Order No. 3045 of the Ministry of Industry and Trade of Russia dated June 25, 2025, “On Amendments to Order No. 90 of the Ministry of Industry and Trade of the Russian Federation dated January 20, 2021,” was published.
In accordance with this order, the procedure for determining the cost and maximum tariffs for services for conducting inspections of pharmaceutical manufacturing facilities, such as checks for compliance with the standards of good manufacturing practice (GMP) of the Eurasian Economic Union, is changed.
One of the key innovations is the transfer of the date of the annual review of the cost of these services to September 1 (previously, the deadline was April 1).
Changes are also being made to the maximum fees for pharmaceutical inspection services (including 20% VAT).
The following maximum fees are being set for Russian manufacturers:
– Full audit – RUB 2.965 million (an increase of 4.5% from the previous level of RUB 2.837 million);
– Abbreviated inspection (subject to the provision of a corrective action plan and a report on its implementation) – RUB 1.120 million (an increase of 4.5% from RUB 1.072 million).
For manufacturers abroad (including inspections jointly with EAEU regulators):
– Full audit – RUB 4.734 million (an increase of 4.5% from RUB 4.530 million);
– Abbreviated inspection – RUB 1.241 million (an increase of 4.5% from RUB 1.187 million).
The order comes into force on September 26, 2025.
http://publication.pravo.gov.ru/document/0001202509150005
September 16, 2025
The Council of the Eurasian Economic Union has supplemented the rules for pharmaceutical inspections
On September 11, 2025, Decision No. 60 of the EEC Council dated August 1, 2025, was published on the official website of the Eurasian Economic Union, amending the rules for pharmaceutical inspections approved by Decision No. 83 of the Council of the Eurasian Economic Commission dated November 3, 2016.
A procedure for monitoring compliance with the EAEU rules of good laboratory practice in the field of medicinal products has been added.
Control is exercised by an inspection appointed by the authorized body (expert organization) of the member state as part of the registration procedures. To initiate an inspection, the decision on its appointment is forwarded to the applicant for registration of the medicinal product (or an authorized person).
The inspection includes checking documents, facilities (infrastructure), records, quality assurance agreements, and any other sources that are considered by the authorized body of a member state of the Eurasian Economic Union to be related to preclinical (non-clinical) research and are located at the research organization (testing laboratory (center)) (hereinafter referred to as the inspected entity), at the facilities of the sponsor (drug developer) or at other organizations involved in preclinical (non-clinical) research and requiring inspection.
In cases where inspection of the inspected entity or other facilities involved in preclinical (non-clinical) research is not required, a documentary inspection may be conducted at the discretion of the authorized body of the member state based on a risk-based approach.
By decision of the pharmaceutical inspectorate, inspections using remote communication means (e.g., audio or video communication) are permitted in the following cases:
a) the threat of, occurrence of, and elimination of an emergency situation and/or the threat of the spread of epidemic diseases that pose a danger to others, diseases and injuries resulting from exposure to adverse chemical, biological, or radiation factors;
b) the occurrence of circumstances of force majeure or circumstances beyond the control of the parties that pose a threat to the life and health of inspectors (e.g., for medical or other reasons).
The document shall enter into force on October 11, 2025.
Reference: https://docs.eaeunion.org/documents/447/10178/
September 15, 2025 г.
Drug production in Russia will be evaluated using a points system starting January 1, 2026
On September 10, 2025, the Russian government approved amendments to Resolution No. 719 of July 17, 2015, on confirming the production of Russian goods.
The scoring system for confirming the production of industrial goods in Russia was launched in 2015. The new Resolution of the Government of the Russian Federation No. 1392 dated September 10, 2025 introduces a scoring system for medicines and pharmaceutical substances as well.
Products can be recognized as Russian if they score at least 50 points for technological processes in the EAEU. The decision will be made by the Ministry of Industry and Trade of the Russian Federation.
According to the government, manufacturers whose products are recognized as Russian will have access to state support tools.
The main goal of introducing the new system for assessing the origin of goods is to expand the range of pharmaceuticals produced in Russia, as well as to create additional incentives for the development of the industry and the adoption of promising technologies for the production of medicines.
The document was published on September 11, 2025, on the official legal information portal and will come into force on January 1, 2026.
Link: http://publication.pravo.gov.ru/document/0001202509110015
September 11, 2025 г.
The EAEU will standardize rules for registering new types of medical devices
The Council of the Eurasian Economic Commission (EEC) has decided to amend the Rules for the Registration and Examination of the Safety, Quality, and Efficacy of Medical Devices, approved by EEC Council Decision No. 46 of February 12, 2016.
The amendments were made by EEC Council Decision No. 50 of July 8, 2025, which was published on the EAEU legal portal on August 28, 2025.
The document establishes rules for working with new medical devices that are not yet included in the unified classifiers, and procedures for their inclusion in the Global Nomenclature of Medical Devices and the EAEU Nomenclature of Medical Devices.
The authorized body (expert organization) shall notify the applicant within ten working days that the procedure for including a new type of device in the following will be launched:
Global Medical Device Nomenclature (GMDN);
EAEU Medical Device Nomenclature.
The medical device will be included in the classifiers only if there are no comments on the registration dossier or if they have been eliminated.
Some appendices have undergone legal and technical amendments. In particular, the following terminology in the Rules has been corrected: “adverse events and/or accidents” has been replaced by “adverse events (incidents)”, and ‘processing’ has been changed to “handling”.
The document will come into force 180 days after publication, on February 24, 2026.
Link: https://docs.eaeunion.org/documents/447/10135/
September 3, 2025 г.
Author
Dmitriy Kovalev
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