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Bill On Manufacturing Individual Gene Therapy Pharmaceuticals In Medical Organisations Without State Registration Submitted to The State Duma

28 October 2026

On 16 October 2026, the Russian Government submitted to the State Duma bill No. 12837-9 (Bill) amending Federal Law No. 61-FZ dated 12 April 2010 "On Circulation of Medicines" (Law on Circulation of Medicines).

The Bill introduces a special circulation regime for individual gene therapy pharmaceuticals (IGTPs): a medical organisation will be able to manufacture such a pharmaceutical for a specific patient and use it on its own premises without registration, on the basis of an authorisation issued by the Russian Ministry of Health.


Turkey’s Nuclear Regulatory Agency Has Tightened the Procedures for Modifying Equipment and Operating Procedures at Nuclear Facilities

27 October 2026

On October 2, 2026, the Official Gazette of Turkey (Resmî Gazete) published amendments by the Turkish Nuclear Regulatory Authority (Nükleer Düzenleme Kurumu, “NDK”) to the Regulation on Licensing Activities for Nuclear Facilities (“Licensing Regulation”) and the Regulation on the Management System for Nuclear Facilities, Radiation Facilities, and Radioactive Waste Management Facilities (“Management System Regulation”). Most of the amendments took effect on the date of publication. The new procedure for making changes at nuclear facilities (Article 41 of the Regulations on Licensing Activities) will take effect on January 2, 2027.

The amendments apply to organizations that carry out activities related to nuclear facilities based on NDK licensing documents (approvals, permits, and licenses). With regard to the Akkuyu NPP, the licensee is Akkuyu Nükleer A.Ş. Organizations within the Rosatom State Corporation that participate in the project as designers, equipment manufacturers, contractors, and service providers are indirectly affected by the amendments through the licensee’s processes and the terms of supply contracts.


India Plans to Introduce Video Surveillance of Prescription Drug Dispensing: Risks and Comparison with Russia

16 October 2026

On September 8, 2026, the Ministry of Health and Family Welfare of India published a draft amendment to the Drugs Rules from 1945, according to which a pharmacy must dispense any prescription drugs under video surveillance that records the dispensing, and keep the recordings for at least three months. For companies operating in both markets, it is important to take into account the difference in approaches. We cover this in more detail in our legal alert.

Consent Not by Default: New Personal Data Processing Rules and a Unified Consent Platform on Gosuslugi

09 October 2026

On 30 September 2026, a draft Federal Law “On Amendments to the Federal Law ‘On Communications’ and Certain Legislative Acts of the Russian Federation” (ID 171465) (hereinafter – the “Draft Law”) was published.

The Draft Law provides for the third package of measures to combat offences committed using information and communication technologies (“Antifraud 3.0”), and consistently continues the two previous ones.

Access to the crypto market: the Bank of Russia approves requirements for digital depositories, crypto exchanges and DFA issuance operators

28 September 2026

Since the beginning of 2025, Russian courts have issued several landmark rulings in the field of personal data processing. These cases affect the interests of banks, marketplaces, solid waste management operators, employers, and online platforms. Some positions confirm long-standing approaches (withdrawal of consent does not terminate processing where a contract or legal obligation exists), while others establish new guidelines for businesses (processing of a beneficiary's data without consent, inadmissibility of contacting a previous employer without the candidate's permission).

Our review covers seven recent cases with conclusions that will help DPOs, legal teams, and information security departments minimize risks and establish compliant processes.

From September 4, 2026, the Law on the Guiding Nature of the Explanations of the Supreme Court Comes into Force

31 August 2026

On August 4, 2026, the President of the Russian Federation signed Federal Constitutional Law No. 3‑FKZ of August 4, 2026, “On Amending Article 19 of the Federal Constitutional Law ‘On the Judicial System of the Russian Federation’ and Article 5 of the Federal Constitutional Law ‘On the Supreme Court of the Russian Federation’” (hereinafter – the “Law”)[1].

The Russian Government Has Submitted a Draft Law Limiting the Grounds for Reducing Court-Appointed Experts’ Remuneration

31 August 2026

The Russian Government has submitted to the State Duma a draft law proposing to regulate the procedure for reducing the remuneration payable to court-appointed experts in civil, commercial and administrative proceedings.

The draft law has been prepared in furtherance of Ruling No. 6-P of the Constitutional Court of the Russian Federation dated 11 February 2026, in which the Constitutional Court of the Russian Federation indicated the need to establish criteria for the permissible reduction of an expert’s remuneration previously agreed and approved by the court.

The Ministry of Justice Has Prepared a Draft Law Distinguishing the Period for Discovering Defects in Goods from the Limitation Period

28 August 2026

The Ministry of Justice of Russia has prepared the draft federal law “On Amendments to Article 477 of Part Two of the Civil Code of the Russian Federation”. The draft law was prepared in order to implement Ruling No. 38-P of the Constitutional Court of the Russian Federation dated 9 June 2026 which declared paragraph 2 of Article 477 of the Civil Code of the Russian Federation unconstitutional to the extent that it creates uncertainty as to whether a buyer may bring court claims after the expiry of the two-year period for discovering defects, provided that the defects themselves were identified within that period.

The Middle East as Pharma’s New Mecca: a Closer Look at the UAE and Saudi Arabia

27 August 2026

Russian pharmaceutical manufacturers are increasingly looking toward the GCC and MENA regions. But "entering" and "establishing a foothold" are challenges of entirely different magnitudes.

The two key markets in the region — the UAE and Saudi Arabia — despite their undeniable appeal, require fundamentally different approaches.

Together with the Pharvestnik Magazine, Julia Kuzmenko, Counsel and Head of Regulatory Practice at Lidings, examined the nuances of the regulatory architecture in these two jurisdictions.