List of strategically important medicines: draft of the Ministry of Health

The Ministry of Healthcare of the Russian Federation with the participation of the Ministry of Industry and Trade pursuant to the order of the Government of the Russian Federation dated 07.06.2023 No. 1495-r, which approved the Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the period until 2030, and paragraph 1 of the action plan for the implementation of the Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the period until 2030, approved by the order of the Government of the Russian Federation dated 30.03.2024 No. 753-r, has prepared a draft law amending the Law on Circulation of Medicines with regard to the provisions on the list of countries of the Russian Federation.

The government will approve the list, the procedure and criteria for its formation. The list will include drugs from the VED list.

The amendments may come into force on May 1, 2025.

All stages of production of such drugs in Russia will be ensured in order to prevent defective drugs or the risk of their occurrence due to the introduction of restrictive economic measures.

Manufacturers will receive state support. Support measures will be determined by the Ministry of Industry and Trade.

October 23, 2024

Link: Draft Federal Law https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=151642

A new updated procedure for the development of pharmacopoeial articles has been approved

On 18.10.2024 the official portal of legal information published the Order of the Ministry of Health № 468n from 13.09.2024.

This order approves the procedure for the development of general pharmacopoeial articles and their inclusion in the state pharmacopoeia, as well as the procedure for posting data on the state pharmacopoeia and its annexes on the official website of the Ministry of Health.

The new document replaces the previous procedure for the development of general pharmacopoeial articles, approved by the order of the Ministry of Health № 756 of 26.08.2010 (including changes for the period from 2013 to 2021).

According to the order of the Ministry of Health, the development of pharmacopoeial articles should be carried out taking into account the EEU pharmacopoeia. Now not only market participants, but also scientific organizations and specialized universities will be able to make proposals for the content of common pharmacopoeial articles.

The document excludes peculiarities of development of common pharmacopoeial articles for reference medicines during the period of validity of the patent for them, which presuppose obtaining the developer’s consent for inclusion of common pharmacopoeial articles in the pharmacopoeia. The requirements to the content of the developed generic pharmacopoeial articles are also excluded.

It should be noted that the procedure for development and approval of generic pharmacopoeial articles has not undergone significant changes. Thus, the general pharmacopoeial articles are subject to approval by orders of the Ministry of Health and constitute the state pharmacopoeia. Then the draft articles are posted by the Ministry of Health on the website and after their discussion, after 30 days the draft of general pharmacopoeial articles or pharmacopoeial article is sent to the Council of the Ministry of Health on the state pharmacopoeia. The Council on State Pharmacopoeia within 30 calendar days from the date of receipt of draft general pharmacopoeial articles and pharmacopoeial articles shall consider drafts of general pharmacopoeial articles and pharmacopoeial articles, taking into account the comments and suggestions received and recommend them for approval or recommend for revision with a motivated justification.

Recommendations of the Council on State Pharmacopoeia are formalized by the minutes of the meeting of the Council on State Pharmacopoeia, which is signed by the Chairman of the Council on State Pharmacopoeia or his deputies, in the absence of the Chairman of the Council on State Pharmacopoeia, and sent by e-mail to the Ministry of Health of the Russian Federation.

Within 90 calendar days after receipt of the minutes of the meeting of the State Pharmacopoeia Council with recommendations for approval of the draft general pharmacopoeia article and pharmacopoeia article, the Ministry of Health of the Russian Federation on the basis of an expert institution provides scientific and technical editing of the draft general pharmacopoeia article and pharmacopoeia article and prepares a draft order of the Ministry of Health of the Russian Federation on the approval of the general pharmacopoeia article and pharmacopoeia article.

In accordance with the new order, the state pharmacopoeia is issued by the Ministry of Health and must be reissued at least once every five years. The deadline for posting data on the pharmacopoeia and its annexes on the website of the Ministry of Health has been increased from three working days to ten working days.

October 18, 2024

Reference:  http://publication.pravo.gov.ru/document/0001202410180014

Drug traceability experiment proposed to be extended

The Federal Portal of Draft Regulatory Legal Acts published a draft decree prepared by the Ministry of Industry and Trade “On Amendments to Decree No. 2261 of the Government of the Russian Federation dated December 22, 2023”.

The draft resolution provides for the extension of the experiment on traceability of medicines and raw materials used for their production until June 30, 2025.

October 15, 2024

Link: http://regulation.gov.ru/p/151355

New interstate standard for specialists in the field of medicine and health care

Order of Rosstandart from 30.09.2024 N 1301-st approved GOST ISO/TS 81060-5-2024 “Non-invasive sphygmomanometers (blood pressure meters). Part 5. Requirements for repeatability and reproducibility of non-invasive blood pressure simulators (NIBP) in the testing of automatic non-invasive sphygmomanometers”.

The standard establishes requirements for the repeatability and reproducibility of non-invasive blood pressure simulators (NIBP) for testing automatic sphygmomanometers using only the oscillometric method. Additionally, the pulse rate set on the NIBP simulator is tested. The standard is not intended to correlate the signals generated by the NIBP simulator with the signal recorded through a cuff worn by a person. Nor is the standard intended to verify the interaction between the NIBP simulator and the automated sphygmomanometer under test (e.g., the correspondence between the set values of the NIBP simulator and the displayed values of the automated sphygmomanometer under test or the properties of the cuff and tubing, such as design or elastic properties).

The enacted standard is assigned to Technical Committee for Standardization N 011 “Medical Devices, Apparatus and Equipment” (TC 011).

October 10, 2024

GOST ISO/TS 81060-5-2024 comes into effect in the territory of the Russian Federation from July 1, 2025.

Changes in the rules for importing medicines into Russia

In accordance with subparagraph “c” of paragraph 39, subparagraphs “a”, “c” of paragraph 40 of Article 1 of Federal Law No. 1-FZ dated January 30, 2024 “On Amendments to the Federal Law ‘On Circulation of Medicines’ and Articles 1 and 4 of the Federal Law ‘On Amendments to the Federal Law ’On Circulation of Medicines” and the Federal Law “On Amendments to the Federal Law ‘On Circulation of Medicines’”, the Ministry of Health has prepared amendments to the rules for importation of medicines into the Russian Federation.

In particular, a draft decree has been prepared on amendments to Resolution of the Government of the Russian Federation No. 853 of 01.06.2021 “On Approval of the Rules for Importation of Medicinal Products for Medical Use into the Russian Federation and Recognition of Certain Acts and Certain Provisions of Certain Acts of the Government of the Russian Federation as null and void”.

It is proposed to authorize the importation of batches of unregistered medicines intended for the development of drugs, scientific and other research. If adopted, the amendments will be in force until 2027.

A draft law concerning the importation of medicinal products has also been prepared. Currently, according to Article 48 of the law “On Circulation of Medicines”, medicines may be imported into the Russian Federation by foreign drug manufacturers, drug developers or other legal entities on behalf of a drug developer to conduct clinical trials, registration and expert examination of medicines intended for circulation in Russia or on the common market within the Eurasian Economic Union. The new draft law proposes to allow importation on behalf of a developer “for the development of medicinal products, scientific and other research” and to replace the wording “research organizations” with “scientific organizations”.

It is proposed to amend the requirements to the documents that an organization submits to obtain an opinion in terms of substantiating the quantity of imported medicinal products and (or) pharmaceutical substances depending on the purpose of importation. In order to justify the volume of the imported batch of unregistered medicinal products for preclinical trials it will be necessary to provide its plan (protocol, program), for clinical trials – information on the scheme of use, for registration – the need for the drug for expert examination within the framework of registration.

According to the summary report to the draft, the amendments are designed to eliminate the gap in the regulation of importation of unregistered medicines for scientific research, including preclinical studies of medicines required for their registration, as well as to harmonize the rules with the EAEU regulations: GMP rules (Decision of the EEC Council No. 77 of 03.11.2016), GCP rules (Decision of the EEC Council No. 79 of 03.11.2016) and registration rules within the EAEU (Decision of the EEC Council No. 78 of 03.11.2016).

October 3, 2024

Link: https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=151068

The list of medicines for veterinary use, food additives and enzyme preparations has been approved

Order of the Ministry of Agriculture of Russia No. 509 dd. 03.09.2024 approves the list of medicines for veterinary use, feed and food additives, enzyme preparations, the production of which is carried out from products (raw materials) that are not agricultural.

The list, in particular, includes medicines for veterinary use corresponding to the codes of the All-Russian Classifier of Products by Economic Activities 21.10.51, 21.10.54.120, 21.10.54.180, 21.10.60.193, 21.20.10, 21.20.21.110, 21.20.21.130 (except for vaccines with storage and transportation temperature of minus 60 degrees Celsius or lower), 21.20.22, 21.20.23.190 (except for vaccines with storage and transportation temperature of minus 60 degrees Celsius or lower).

The order was published on the official Internet portal of legal information on 02.10.2024. The start of the document is 13.10.2024.

October 2, 2024

Link: http://publication.pravo.gov.ru/document/0001202410020008