BRACE Law Firm presents its regular regulatory digest on the Russian pharmaceutical industry and Life Sciences sector for September 2019.

September 2019 saw significant regulatory and legislative activity, along with the adoption of key legal acts shaping pharmaceutical compliance and operations:

• The Eurasian Economic Commission (EEC) Collegium drafted Guidelines for the Preclinical and Clinical Development of Combination Medicinal Products, Guidelines for Determining the Scope of Laboratory Testing in the Evaluation of Medicines, and the Procedure for Maintaining the Nomenclature of Dosage Forms and the Directory of Routes of Administration of Medicinal Products.

• The Government of the Russian Federation approved the procedure for recognizing and assessing the compliance of testing laboratories (centers) with the Organization for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice (GLP).

• The Ministry of Health of the Russian Federation proposed a new methodology for calculating and determining the initial (maximum) contract price (IMCP). The Ministry also proposed amendments to the model contract for the supply of medicinal products for medical use to ensure alignment with current public procurement laws.

• Federal Law No. 325-FZ dated September 29, 2019, mandates that the Single Tax on Imputed Income (STII) regime shall no longer apply to the retail sale of medicines effective January 1, 2020.

• The Ministry of Industry and Trade of the Russian Federation approved a model agreement for providing serialization and track-and-trace marking codes to entities engaged in the circulation of medicines.

• The Ministry of Health of the Russian Federation released a draft of the 2020 Vital and Essential Drugs List (VEDL) scheduled for official approval.

This digest provides a detailed review of these critical statutory amendments, enforcement landscapes, and upcoming legislative initiatives.

1. Statutory Enactments, Regulatory Acts, and Legal Updates

1.1. Eurasian Economic Commission Issues Recommendations on the Development of Combination Medicinal Products

Recommendation of the Collegium of the Eurasian Economic Commission No. 25 dated September 2, 2019, “On the Guidelines for the Preclinical and Clinical Development of Combination Medicinal Products”

This document outlines regulatory approaches to the preclinical and clinical development of combination medicinal products (fixed-dose combinations of active substances) containing two or more active pharmaceutical ingredients (APIs) within a single dosage form.

The scope and design of preclinical studies required for a combination drug depend on existing safety and efficacy data for the individual active substances, as well as the proposed indication(s) for the combination product. The guidelines outline several scenarios for active substance combinations within a medicinal product:

• Combination medicinal products featuring a fixed combination of active substances registered as single-component medicines in at least one EAEU member state and historically utilized in global clinical practice as approved drugs;

• Fixed-dose combination products registered as single-component medicines in at least one EAEU member state but not previously utilized in this specific combination within global clinical practice;

• Multi-component drugs containing one or more novel active substances that have not been previously registered in any EAEU member state as single-component or combination drugs, and lack precedent in global clinical practice as approved medicinal products.

Sponsors must conduct safety evaluations covering the general toxicological properties, genotoxicity, and carcinogenicity of the specific active substance combination.

1.2. EAEU Establishes Guidelines for Determining the Scope of Laboratory Testing in Pharmaceutical Evaluations

Recommendation of the Collegium of the Eurasian Economic Commission No. 28 dated September 10, 2019, “On the Guidelines for Determining the Scope of Laboratory Testing in the Evaluation of Medicines”

The guidelines provide recommendations on scoping laboratory testing for medicinal product samples to confirm compliance with quality specifications and to verify analytical quality control methodologies during registration or marketing authorization variations. This follows the Rules for Registration and Evaluation of Medicinal Products for Human Use approved by Decision of the Council of the Eurasian Economic Commission No. 78 dated November 3, 2016.

Regulatory agencies determine the selection of required laboratory tests based on the specific manufacturing parameters of the medicinal product:

• For marketing authorization application evaluations where a drug is manufactured across multiple sites (bulk product manufacturing) utilizing an active pharmaceutical ingredient (API) from a single manufacturer, complete laboratory testing against all quality metrics must be performed on samples from at least one manufacturing site;

• In cases where the drug is manufactured at a single site using APIs from different manufacturers, full-spectrum laboratory testing must be conducted on drug samples manufactured at that site using the API of at least one manufacturer;

• Under evaluations where the drug is manufactured across multiple sites using APIs from different manufacturers, testing across all parameters must be performed on samples from one site using one manufacturer's API (excluding biological medicinal products).

For biological medicinal products, testing must encompass all quality indicators across all manufacturing sites and utilize APIs from all declared manufacturers.

1.3. EAEU Approves Dosage Form Nomenclature and Maintenance Protocols

Decision of the Collegium of the Eurasian Economic Commission No. 158 dated September 17, 2019, “On the Nomenclature of Dosage Forms and the Directory of Routes of Administration of Medicinal Products”

The nomenclature utilizes a combined methodology for data classification.

The nomenclature entries establish a three-tiered hierarchy. The physical state of the matter constitutes the first level of classification. The primary type of dosage form forms the second level. The third level classifies dosage forms based on the following criteria:

• Ready-to-use status of the dosage form;

• Type of modified release of active substances;

• Route of administration of the medicinal product;

• Method of administration of the medicinal product;

• Form of application.

The designated nomenclature operator shall update records at least once a month upon identifying new classification objects or when existing records require modification, based on:

• Submissions from competent authorities (organizations);

• Minutes of meetings involving representatives of competent authorities (organizations) convened by the Commission's department responsible for pharmaceutical market regulation within the EAEU.

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