Mutual Recognition Agreements (MRAs) allow pharmaceutical regulatory authorities to rely on defined elements of one another’s Good Manufacturing Practice (GMP) inspection systems. By reducing unnecessary duplication of inspections and, where applicable, batch testing, these agreements support international regulatory cooperation while maintaining oversight of medicinal product quality. However, mutual recognition is conditional. Its scope depends on the legal framework, the authorities involved, the products covered, the types of inspections concerned...

The European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) has recommended granting a marketing authorisation for Scovella (velagliflozin), marking the first positive recommendation for a veterinary medicinal product under the European Union’s limited market regulatory framework established by Regulation (EU) 2019/6. The positive opinion was adopted on 5 November 2026 following a re-examination of the Committee’s negative opinion issued in June. The applicant is Boehringer Ingelheim Vetmedica GmbH. Indication...

Australia’s Therapeutic Goods Administration (TGA) has reported laboratory testing failures in four unapproved peptide products marketed under the Synedica brand. Testing found no detectable TB-500 in three formulations and identified lower-than-declared retatrutide content with significant variation between samples. The findings emerged from the regulator’s cooperation with New South Wales Police in an investigation into the alleged illegal manufacture and distribution of peptide products. Laboratory testing reveals discrepancies in product composition According...

India’s Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, that would require licensing authorities to immediately suspend the manufacturing licence for a drug declared Not of Standard Quality (NSQ) under specified circumstances. The draft also proposes mandatory root cause analysis (RCA), corrective and preventive action (CAPA), and changes to the distribution of Government Analyst test reports. Two proposed routes for immediate licence suspension The draft...

The U.S. Food and Drug Administration (FDA) has required application holders for all glucagon-like peptide-1 receptor agonist (GLP-1 RA) medicines to update product labelling with a warning about a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition that can cause sudden, painless vision loss in one eye and may result in permanent visual impairment. The requirement was announced in an FDA Drug Safety Communication...