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Guideline For Good Clinical Practice (Ich E6 R (3)): Overview of Key Changes in The New Edition

17 June 2025

On 23 July 2025, a part of the Good Clinical Practice Guideline, GCP E6 (R3), promulgated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) comes into force. The development of new technologies, the rapidly evolving clinical trial (CT) ecosystem, and the need to respond quickly to deviations in CT processes have prompted the revision of the current version of GCP ICH E6(R2), which is valid until 22 July 2025.



Amendments to the Procedure for the State Register Medicines Maintaining: What Has Changed?

15 May 2025

On 6 May 2025, the updated version of the Order of the Ministry of Health dated 9 February 2016 No. 80n “On the Approval of the Procedure for Maintaining the State Register of Medicines for Medical Use” (the “Order”) came into force. The amendments were made in accordance with Order of the Russian Ministry of Health dated 17 March 2025 No. 129n, officially published on 25 April 2025.

Lidings – Strategic Partner of the Conference on Legal Issues in Pharmaceutical Industry

10 April 2025

April 10th, 2025 annual conference Pharmaceuticals – 2025: Legal Issues will take place in Moscow organized by Pravo.ru. Lidings lawyers take an active part in the event’s program.

As a strategic partner of the conference, we aimed to make the program rich and actual. Together with pharmaceutical industry experts and lawyers, we will discuss how the market has changed in 2024 and what awaits us in 2025.

New Procedures for Conducting Clinical Trials Have Taken Effect

17 February 2025

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.