Three medicine safety updates — 21 August 2026

21 August 2026 — PharmExpert identified three important updates for marketing authorisation holders, pharmacovigilance professionals and medicine-quality teams.

1. Russia: new GVP/GCP inspection requirements

The Government of the Russian Federation adopted Resolution No. 1028 dated 19 August 2026, officially published on 20 August 2026. It adds points 10–48 to Annex 28 of Government Resolution No. 353.

The new provisions establish a mechanism for confirming a marketing authorisation holder’s compliance with Eurasian Economic Union Good Pharmacovigilance Practice through pharmaceutical inspections. They also regulate confirmation of clinical-trial sponsors’ compliance with EAEU GCP. Points 10–48 apply through 31 December 2029.

Practical impact: foreign and Russian MAHs should review PV-system inspection readiness, including the pharmacovigilance system master file, procedures, contracts and safety-data exchange agreements, case-processing and signal-management records, risk-management documentation, training, audits and CAPA.

Official publication of Resolution No. 1028

2. FDA: Glutathione Injection recalled for elevated endotoxins

Optimal Balance Pharmacy is recalling certain Glutathione Injection 200 mg/mL, 30 mL vials, lot LG342009076, expiry 4 October 2026, to patient level because of elevated bacterial endotoxin levels.

Reported events included fever, chills, severe headache, nausea, vomiting, pain and allergic-reaction symptoms. Potential consequences include hypotension, inflammatory reactions, anaphylactic shock and death. Importance: critical.

Official FDA notice

3. France: Tavneos recalled after an unfavourable benefit-risk conclusion

ANSM announced the recall of 13 batches of Tavneos 10 mg (avacopan) following withdrawal of the marketing authorisation. The action follows the European Commission decision of 4 August 2026 based on an unfavourable benefit-risk balance. The recall covers pharmacies, healthcare institutions and the pharmaceutical supply chain.

Official ANSM notice

Recommended actions

• Assess the impact of Resolution No. 1028 on the Russia/EAEU PV operating model and inspection readiness.
• Check for the affected Glutathione Injection lot and implement the recall instructions.
• Check affected Tavneos batches and applicable local withdrawal actions.
• Document applicability assessments, decisions and any resulting CAPA.

This update is provided for regulatory awareness and does not constitute legal or medical advice.