New Procedures for Conducting Clinical Trials Have Taken Effect

17 February 2025
Ivan Tarasenko
Legal Trainee
Artem Zakharchenko
Associate

On 4 February 2025, the official portal of legal information were posted:

  1. Order of the Ministry of Health No. 708n of 23 December 2024 “On Approval of the Procedure for Maintaining the Register of Issued Permits to Conduct Clinical Trials of Pharmaceuticals” (“Order No. 708n”) - the document replaces Order of the Ministry of Health No. 754n dated 26 August 2010;
  2. Order of the Ministry of Health No. 706n dated 20 December 2024 establishing the procedure for the Ministry of Health to publish on its website a list of medical organisations conducting clinical trials (“Order No. 706n”) - the document replaces Order of the Ministry of Health No. 752n dated 26 August 2010.

Both documents entered into force on 15 February 2025 and aim to harmonise with the provisions of the EAEU regulations, as well as to simplify the system of information resources maintenance by the Ministry of Health by abolishing the “paper” document flow.

Key changes under the Order No. 708n

  • The register of issued authorizations to conduct clinical trials of pharmaceuticals (“Register”) is carried out in electronic form. Previously, it was possible to keep it in physical form.

  • Records in the Register are made at the same time as the decision of the Ministry of Health to conduct a clinical trial.

  • The status changes of the clinical trial (completed/suspended/terminated) are made within 5 business days after receiving notification from the organizer of clinical trial.

  • The register record includes the following information: INN and/or trade name, country of the pharmaceutical developer, start and finish date of the clinical trial, identification number of the clinical trial report, phase of the clinical trial, type of the clinical trial, number of medical organizations conducting the clinical trial, area of use of the pharmaceutical in respect of which the clinical trial is conducted, etc.

Key changes under the Order No. 706n

  • The list of medical organizations conducting clinical trials of medical products (“List”) is carried out in electronic form only;

  • The List contains the following information:

  1. name of the medical organization;

  2. name of the constituent entity of the Russian Federation where the medical organization is located;

  3. the legal address of the medical organization;

  4. address or addresses of the medical organization performing medical activities in accordance with the license;

  5. the number of clinical trials conducted in the medical organization.

  • The Ministry of Health, simultaneously with the decision to issue an authorization to conduct clinical trials or to make changes to it, entries the relevant information in the List on the official website.