A new regulation on state control of medicinal products circulation

Russian Federation Government Decree No. 1049 dated June 29, 2021, “On Federal State Control (Oversight) in the Sphere of Medicines Circulation,” approved the new Regulation on Federal State Control (Oversight) in the Sphere of Medicines Circulation (hereinafter the “Regulation”). The Regulation entered into force on July 1, 2021. Simultaneously, the Government repealed Government Decree No. 1043 dated October 15, 2012, “On Approval of the Regulation on Federal State Oversight in the Sphere of Medicines Circulation,” along with several other governmental acts.

The Regulation establishes that the scope of federal state control (oversight) in the sphere of medicines circulation encompasses:

• Adherence to mandatory requirements within the sphere of medicines circulation, including requirements for preclinical and clinical trials of medicines, as well as ensuring that marketed pharmaceutical products comply with established quality, efficacy, and safety standards;
• Compliance by regulated entities with the restrictions established by Articles 67.1 and 67.2 of the Federal Law “On the Circulation of Medicines” (governing statutory restrictions on operations in the pharmaceutical sector and requirements for conducting scientific events for medical professionals);
• Fulfillment of licensing requirements for conducting pharmaceutical activities;
• Strict observation by regulated entities of information disclosure and reporting requirements regarding medicines and/or pharmaceutical products.

The Regulation includes a dedicated chapter on risk management, classifying risks into the following categories:

• Significant risk;
• Medium risk;
• Moderate risk;
• Low risk.

Authorities classify state oversight targets into specific risk categories based on statutory classification criteria developed for the sphere of medicines circulation. The appendices to the document detail these criteria, which encompass operational conditions for the manufacturing, storage, and transportation of medicines, among other factors.

The assigned risk category determines the frequency of specific control (oversight) measures:

• For the significant risk category: inspection visits, on-site audits, and desk audits shall occur once every 3 years;
• For the medium risk category, one of the specified oversight measures (inspection visit, on-site audit, or desk audit) shall occur once every 5 years;
• For the moderate risk category, one of the specified oversight measures (inspection visit, on-site audit, or desk audit) shall occur once every 6 years;
• Regulated objects assigned to the low risk category shall be exempt from scheduled inspections.

The Regulation introduces structured mechanisms for violation prevention, featuring the following preventative measures:

• Information dissemination;
• Reviews of enforcement practices;
• Issuance of precautionary warnings;
• Compliance counseling;
• Preventative site visits.

Where evidence indicates imminent violations, authorities may issue a formal precautionary warning regarding the inadmissibility of violating mandatory requirements, instructing the entity to take corrective measures to ensure full compliance. The regulated entity may file an objection against the specified warning within 15 calendar days from the date of receipt.

To gather evidence of compliance violations, authorized oversight officials and engaged experts may utilize photography, audio, and video recording during test purchases, on-site audits, and inspection visits.

Furthermore, the document institutes continuous monitoring of compliance with mandatory requirements (safety monitoring or pharmacovigilance). This monitoring aims to identify side effects, adverse reactions, serious adverse events, unexpected adverse reactions, individual intolerances, or a lack of efficacy in pharmaceutical products. It also covers any other facts and circumstances posing a threat to human or animal life and health during the use of medicinal preparations, detected at any stage of pharmaceutical circulation within the Russian Federation or internationally.

In addition, Roszdravnadzor (the Federal Service for Surveillance in Healthcare) shall annually approve a risk-prevention program to safeguard legally protected interests, publishing the document on its official website.

These regulatory changes fundamentally shift the focus of state inspections by prioritizing preventative measures and embedding a risk-based approach, which we anticipate will significantly reduce compliance violations.