Black Triangle Scheme Information for Sponsors
Guidelines on the inclusion of the Black Triangle symbol and related information in Product Information (PI) and Consumer Medicine Information (CMI) for medicines under the Black Triangle Scheme, including details on registration, duration, and exit procedures.
TGA | Pharmaceuticals | Regulatory AffairsEU Pharmacovigilance Regulation (EU) 2025/1466 Now in Effect: Strengthening Pharmacovigilance Compliance Across the EU
The implementation of Commission Implementing Regulation (EU) 2025/1466 strengthens EU pharmacovigilance requirements, introducing enhanced expectations for governance, risk-based oversight, PSMF management, vendor oversight, and inspection readiness.
EMA | Pharmaceuticals | PharmacovigilanceEgypt Updates Bioequivalence Guideline with ICH M10 and M13A Implementation
The Egyptian Drug Authority (EDA) has updated its Bioequivalence Guideline for generic product marketing authorization by implementing ICH M10 and ICH M13A requirements. The update also revises regulatory expectations for bioavailability and bioequivalence study centers.
EDE | Pharmaceuticals | Regulatory AffairsEMA Revised Compilation of Union Procedures on GMP/GDP Inspections — Updated June 2026
EMA published a fully revised Compilation of Union Procedures on GMP/GDP Inspections in June 2026, updating the authoritative reference framework used by all EU/EEA inspectors and industry for pharmaceutical manufacturing and distribution compliance.
EMA | Pharmaceuticals | Compliance, Audit and ValidationEMA Revised EU Variation Guidelines — Mandatory Compliance from 15 January 2026; Type IA Annual Update Deadlines from November 2026
The revised EU Variation Guidelines, mandatory for all variation submissions since 15 January 2026, introduce immediate implementation requirements for safety-related Type II variations and time-bound annual update obligations for Type IA variations, with the first annual update windows opening from November 2026.
EMA | Pharmaceuticals | Compliance, Audit and Validation
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