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254 changes Guidance, last 7 days

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Banca d'Italia: Expert Assessment in Credit Rating System

The Bank of Italy has published an analysis (N. 79) detailing recent methodological improvements to its internal credit rating system for non-financial companies (ICAS). The study, based on over 25,000 expert assessments from 2016-2022, highlights how expert judgment, including climate and sector risk analysis, significantly enhances rating predictive power and stability during economic stress.

Routine Guidance Financial Services
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AI Adoption Impact on Italian Firms' Productivity and Profitability

Banca d'Italia published a paper analyzing the economic impact of AI adoption on Italian firms. The study found that AI adoption increases productivity and profitability, leading to a reallocation towards more qualified roles without negative overall employment effects.

Routine Guidance Artificial Intelligence
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Italian Less Significant Banks' Corporate Lending Deterioration Analysis

Banca d'Italia published an analysis on corporate lending by Italian less significant banks (LSI) compared to significant groups (SI). The study found that LSIs have a higher loan deterioration rate, largely due to a greater proportion of loans to smaller, higher-risk businesses.

Routine Guidance Banking
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Generative AI for Bank Carbon Data Gaps

Banca d'Italia published a paper exploring the use of Generative AI (GenAI) to address gaps and inconsistencies in carbon emission data reported by major Euro area banks. The research assesses GenAI's ability to supplement traditional data sources, noting its potential while also highlighting quality and transparency concerns.

Routine Guidance Financial Services
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PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in February 2026. These recommendations require marketing authorisation holders (MAHs) to provide supplementary information or take regulatory action, such as updating product information.

Priority review Guidance Pharmaceuticals
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PRAC Recommendations on Signals - January 2026 Meeting

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in January 2026. Marketing Authorisation Holders (MAHs) for affected medicinal products are required to update product information within specified timelines.

Priority review Guidance Pharmaceuticals
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PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in November 2025. Marketing Authorisation Holders (MAHs) are required to provide supplementary information or update product information based on these recommendations, with specific deadlines for certain signals.

Priority review Guidance Healthcare
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PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in their October 2025 meeting. These recommendations are directly actionable by marketing authorisation holders (MAHs) for updates to product information.

Priority review Guidance Pharmaceuticals
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Bundeskartellamt Market Power Report: Electricity Producers

The Bundeskartellamt's Market Power Report 2024/25 indicates a significant increase in market power for major German electricity producers like RWE and LEAG following the decommissioning of dispatchable power plants. The report highlights concerns about competition and suggests measures to reduce market concentration in upcoming tenders for new power plants.

Priority review Guidance Antitrust & Competition
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ACPR, AMF Joint Approach for Client Sustainability Preferences

The ACPR and AMF have jointly developed a supervisory approach to help financial investment advisers and life insurance professionals comply with regulations requiring them to consider clients' sustainability preferences. This guidance provides practical solutions for integrating these preferences into advisory services.

Priority review Guidance Financial Services

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