Latest news with #regulatoryCompliance
Finextra
03-07-2025
- Business
- Finextra
ECB outlines plans for integrated regulatory reporting across Europe
European and national authorities have joined forces with banks to integrate reporting requirements across Europe. 0 This will reduce costs for banks and improve data quality. In this blog post we describe the European integrated reporting initiative and present some initial results. Collecting data from banks is essential for authorities to conduct monetary policy, supervision and resolution. But banks in Europe are facing more and more regulatory reporting requirements from various European and national authorities. These requirements often differ in terms of definitions, reporting deadlines and templates. For banks, this lack of harmonisation makes reporting unnecessarily burdensome; for authorities, it complicates sharing and analysing data. In the context of the European initiative on integrated reporting, the European Banking Authority (EBA) and the European Central Bank (ECB) established the Joint Bank Reporting Committee (JBRC) in March 2024. Our goal is to harmonise and simplify banks' reporting of statistical, supervisory and resolution data, working in close collaboration with the banking industry. This initiative fundamentally enhances the European approach to banks' data reporting. Harmonising reporting standards will reduce the reporting burden on banks and enhance data quality. This aligns with the European Commission's simplification initiative aimed at boosting Europe's competitiveness. The JBRC brings together high-level representatives from European and national authorities to explore ways of making banks' reporting more efficient. It provides, for example, advice on how to harmonise definitions and reporting deadlines and how to share data among authorities more efficiently, thus enabling banks to avoid double reporting. Ideally, data would only be reported by banks once and could then be shared and reused by all authorities. The JBRC consists of the ECB, the EBA, the European Commission and the Single Resolution Board, as well as the national authorities that issue supervisory, resolution and statistical reporting requirements in the European Economic Area (Figure 2). To ensure close collaboration with the banks, we have set up a reporting contact group (RCG) composed of data reporting experts from the banking industry. The RCG holds joint meetings with the JBRC Steering Committee, which coordinates the JBRC's activities. These meetings provide a forum for authorities and reporting banks to cooperate and exchange views. In addition, hands-on cooperation can take place within the JBRC expert groups, which include technical experts from the banking industry and look more closely at the technical details of banks' reporting. The RCG will share with the authorities their practical insights on how to formulate reporting requirements. The authorities will continue to determine, depending on their policy needs, what the banks must report. The EBA's feasibility study on integrated reporting put forward a long-term vision for moving from the current system of supervisory reporting by financial institutions to a modern, efficient and effective reporting process. The JBRC was established as part of that long-term vision and has also begun work on other key areas for achieving fully integrated reporting of statistical, supervisory and resolution data. First steps towards integrated reporting The JBRC has already produced some tangible results towards more integrated reporting. Its work programme for 2025 prioritises work on common terms and definitions. It also focuses on the harmonised implementation of the revision of the statistical classification of economic activities in the European Union (abbreviated as NACE). Harmonising implementation of statistical revisions Banks use NACE to classify in their regulatory reporting the kind of counterparties they do business with. The European Commission updated NACE in October 2022. Banks still report data using the previous NACE classification but will eventually have to switch to the new version. Ideally, this shift will happen for all reporting at the same time in order to avoid parallel reporting using different classification systems. The JBRC therefore advised that the NACE revision should be implemented across the European banks' reporting frameworks simultaneously as of January 2026. The EBA and the ECB have already committed to this new implementation date. The JBRC encourages national central banks to follow the same implementation date for any national statistical data collections in which the NACE classification is used. Using the same language in reporting Another important task is to develop a common data dictionary that defines the meaning and structure of the data to be reported. For this purpose, the JBRC has set up an Expert Group on Semantic Integration, which gives advice on how to harmonise definitions of concepts - called semantics - used in reporting requirements. One focus of this group will be to give preliminary advice to the authorities on new, upcoming legislation, since definitions in draft legislation are easier to revise than definitions that are already firmly enshrined in law. Semantic integration is the process of aligning different reporting frameworks. This is done by identifying and linking elements that represent the same concepts and by standardising the terms and definitions. In the example in Figure 3, the statistical concept 'Type of instrument' matches the supervisory concept 'Instrument'. With semantic integration, we establish a uniquely defined concept ('Type of instrument') for both statistical and supervisory reporting. This concept is broken down into its constituent components, in the form of a hierarchy, with mapping across the two reporting frameworks. Having uniquely defined concepts significantly reduces the reporting burden. One of the high priority activities in 2025 is the semantic alignment of the Eurosystem's Integrated Reporting Framework (IReF) with other banking data collection frameworks, in particular financial reporting (FinRep) used for supervisory purposes. The IReF is currently scheduled to enter into force by the end of 2029. It will integrate several statistical ECB regulations into one regulation. This will help remove overlaps and harmonise reporting deadlines within the Eurosystem. In the coming months, the group will start working on the semantic integration of sustainability reporting, while also exploring further potential synergies with other frameworks, such as resolution reporting. These requirements would benefit from harmonised concepts and definitions and, together with the work on the IReF, will ultimately contribute to the creation of a common data dictionary and to the definition of the next steps towards a fully integrated reporting framework. While semantic integration is the current priority, the JBRC is also laying the groundwork for broader progress across all key areas identified in the EBA's feasibility study. The focus on semantic integration represents an important and constructive first step, creating a solid foundation to achieve fully integrated reporting of statistical, supervisory and resolution data. Conclusion Integrated reporting of statistical, supervisory and resolution data by banks would make bank reporting more efficient and improve data quality. It would also address past inconsistencies and redundancies, ensuring that such issues can be avoided in future legislation. The JBRC has made some promising first steps in this direction. It will continue to work in close collaboration with the banking industry to achieve our goal of truly integrated reporting in Europe.
Malay Mail
03-07-2025
- Malay Mail
Johor police: 150 men detained in raid on 64 car wash outlets across Iskandar Malaysia
JOHOR BARU, July 3 — A total of 147 foreign men and three local men, aged 21 to 57, were detained in a coordinated enforcement operation at 64 car wash centres across the Iskandar Malaysia yesterday. In a statement, Johor police chief CP Datuk M. Kumar said the joint operation with other agencies targeted non-compliance among operators, as well as offences involving undocumented migrants, drugs and online gambling. Investigations are underway under immigration laws for permit violations, overstaying and lacking valid documents, alongside offences under the Dangerous Drugs Act and the Common Gaming Houses Act. Kumar said offenders face penalties of up to RM100,000, jail sentences of two to five years and whipping for certain offences. Further action included investigations into illegal water connections, business licensing breaches and failure to display price tags under relevant regulations. Authorities also seized equipment and issued compounds to unlicensed premises. 'The operation achieved its objective of ensuring regulatory compliance and addressing illegal activities involving undocumented migrants,' he said. — Bernama
Entrepreneur
01-07-2025
- Business
- Entrepreneur
Zango AI Raises USD 4.8 Mn Round Led by Nexus Venture Partners
The funding will be used to scale teams in Bengaluru and London, and to further develop Zango's AI-native Governance, Risk, and Compliance (GRC) product suite. You're reading Entrepreneur India, an international franchise of Entrepreneur Media. Regulatory compliance startup Zango AI has raised USD 4.8 million in a seed funding round led by Nexus Venture Partners, with participation from early backers South Park Commons, Richard Davies (CEO, Allica Bank), Alan Morgan (Senior Partner at McKinsey), Mark Ransford (Notion Capital), No Label Ventures, and Start Ventures. The funding will be used to scale teams in Bengaluru and London, and to further develop Zango's AI-native Governance, Risk, and Compliance (GRC) product suite. The company also plans to expand into adjacent verticals such as insurance and asset management, building on its success in banking. Founded in 2024 by second-time entrepreneurs Ritesh Singhania and Shashank Agarwal, Zango AI offers a regulatory compliance platform that combines AI-powered agents with human expertise to automate critical compliance functions like horizon scanning, gap analysis, and controls testing. The company operates out of San Francisco, London, and Bengaluru and is already used by major financial institutions including Novobanco, Monzo, and Juni. Zango's cloud-native platform leverages regulatory-domain-specific large language models to build intelligent agents that continuously track regulatory changes, flag compliance gaps in real time, and ensure institutions remain audit-ready — eliminating the need for manual reviews and spreadsheets. "We don't sell a platform — we sell a solution," said Ritesh Singhania, Co-founder of Zango. "Our AI agents are paired with humans-in-the-loop to ensure 100% accuracy. Peace of mind doesn't come from a tool; it comes from a result. That's why we win against consultants — because they don't just sell software, and neither do we." Both founders bring deep domain experience: Singhania previously founded ClearGlass, a pension regulation platform, while Agarwal co-founded Third Watch, an AI fraud detection startup acquired by Razorpay. Anand Datta, Partner at Nexus Venture Partners, said, "The global regulatory landscape is ripe for disruption. Ritesh and Shashank bring a first-principles approach, uniquely marrying AI with compliance expertise. Zango is already augmenting compliance teams and boosting efficiency at global institutions."
Yahoo
25-06-2025
- Business
- Yahoo
Worldline response to EIC
Worldline Group press release following the publication of articles by the European journalism network EIC - 25 June 2025 Worldline operates in a demanding and constantly evolving regulatory environment, especially the one related to HBR (High Brand Risk) sectors, such as online casinos, online stockbrocking or adult dating services. Since 2023, the Group has strengthened its merchant risk framework to ensure full compliance with laws and regulations, conducted a thorough review of its HBR portfolio— which currently accounts for approximately 1.5% of its acquired volumes — and has terminated commercial relationships deemed non-compliant with its strengthened merchant risk framework. As indicated in previous financial communications, these decisions affected merchants representing €130 million run rate revenue in 2024. As an indication, according to the latest international schemes reports, Worldline's fraud ratio is below the industry average. All HBR clients still active within this portfolio are now subject to enhanced oversight, based on specific procedures. Additional requirements in terms of controls, verifications and evidence documentation have been introduced to ensure ongoing alignment with regulatory obligations and our enhanced internal standards. Worldline has progressively ramped up its first and second-line resources to implement the enhanced requirements as part of the ongoing Group-wide Financial Crime Compliance (FCC) strategy to pursue reinforcement of supervision and controls with regular engagement with the relevant regulatory authorities. Wherever the Group identifies indications of non-compliant situations, additional checks are immediately undertaken, potentially leading to termination of the client relationship. Worldline's Executive Management and Board of Directors are fully committed to strict compliance with regulation and risk prevention standards and to strictly enforce related rules and procedures with zero-tolerance. Attachment Worldline response to EIC_June25
Yahoo
24-06-2025
- Business
- Yahoo
FDA Regulatory Compliance for Drug and Biotech Products - 2 Day Virtual Training Course, July 16-17, 2025: Enhance Compliance Skills with Expert-Led Training and Resources
Enhance your regulatory compliance skills with a comprehensive course on FDA regulations for biologics and drug development. Learn practical applications for ensuring compliance with the FD&C Act and GMP regulations in drug manufacturing and testing. Attendees receive presentation slides, a participation certificate, a Q&A session, and free compliance handouts. Dublin, June 24, 2025 (GLOBE NEWSWIRE) -- The "FDA Regulatory Compliance for Drug and Biotech Products (ONLINE EVENT: July 16-17, 2025)" training has been added to offering. Enhance your knowledge of Regulatory Compliance with this specialized live seminar focused on the essential practices mandated by the Federal Food, Drug, and Cosmetic Act. Dive into the practical applications necessary for ensuring adherence to FDA regulations in biologics and drug development, a critical component for both sponsors and regulatory agencies. This seminar offers an insightful exploration of the graded approach in compliance, vital for pharmaceutical and biotechnology companies striving to meet Good Manufacturing Practice (GMP) regulations effectively. This includes the meticulous management needed in manufacturing, testing, and controlling clinical supplies, as well as overseeing commercial product outputs. This live training Seminar includes the following for each registered attendee: A copy of the presentation slides by download A certificate of participation for attendee training records Q/A Session Free Handouts on FDA Regulatory Compliance This course will benefit professionals involved in working with pharmaceutical and Biotech products and management involved in drug development and FDA Regulatory Compliance: QA/QC analytical chemists QA/QC directors, managers Investigators in QA/QC Manufacturing/Production Research and Development Project management Manufacturing personnel CROs analysts Technical liaison Regulatory affairs personnel CMC specialists Senior quality managers Quality professionals Regulatory professionals Compliance professionals Quality auditors Document control specialists New hires, as well as Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance. Course Agenda: Day 1 FDA and its Statutory and Regulatory Requirements FDA's Structure and Purpose The Federal Food, Drug and Cosmetic Act The Code of Federal Regulations Guidane, Policy Documents and Compliance Manuals The Evolution of FDA Law Brief Overview: The Products FDA Regulates and Their Pathways to Market Drugs Medical Devices Food & Dietary Supplements Cosmetics Tobacco Veterinary Products Universal Requirements Establishment Registration, Product Listing, User Fees, etc. FDA Drug Development and Approval Process Considerations Statutory and Regulatory Provisions Citizen Petitions Approvals and Clearances The Drug IND, NDA, ANDA and Orphan Designation Biologic's BLA Medical Device 510(k) and PMA Combination Products Veterinary INAD, NADA, ANADA, MUMS FDA Drug Approval Process Case Study # 1: Suitability Petitions Case Study #2: Paragraph IV Certification Post Approval Submissions QbD product development and design Key elements of IND, NDA/ANDA applications and FDA expectations Electronic CTD format and content, most submitted through ESG (Electronic Submissions Gateway) Post approval changes to process, methods etc. Regulatory Filings Risk analysis Statutory and Regulatory Compliance The Concepts of "Adulteration" and "Misbranding" Identifying Non-Compliance Product Label and Labeling The Internet Approval and Clearance Facility Inspections Adverse Events Recalls Trade Complaints and Anonymous Tips FDA's Compliance Options, Historical Case Examples & FDA's Website Form 483s Untitled Letters Warning Letters Import Alerts Seizures Recalls Consent Decrees Temporary and Permanent Injunctions Civil and Criminal Prosecution The Park Doctrine Other Compliance Bodies DOJ, FTC, EPA, the States, NAD Management's Role and Responsibilities in Compliance Communication, Implementation and Decision Making Quality Policy and Resourcing Personnel Training Escalation of issues to upper management Corrective and Preventive Actions (CAPA) Gap Analysis Facility Audits and Inspections Internal Company Audits Training the Employees Use of Third-Party Auditors Auditor qualifications understanding Learn Key critical audit areas Internal auditing procedures and schedule Supplier and Customer Audits FDA Inspections Foreign Inspections The FDA Form 483 Strategies for Successfully Responding to a Form 483 including Inspection Observations and Violations The Written Response Communication with FDA Disagreements with Form 483 Observations When the Form 483 Becomes a Warning Letter Course Agenda Day 2 Manufacturing and Quality Controls for Drug Products Management's Role and Involvement Complying with Good Manufacturing Practices "cGMPs" Laboratory Quality Controls Standard Operating Procedures What Makes a Good SOP How to Write an Adequate SOP Strategies for Drafting Recalls and Market Withdrawals FDA Jurisdiction and Authority Stock Rotations Corrections Market Withdrawals Recalls Recall Classifications How to Conduct a Product Recall Customer Communication FDA Communication Documentation Strategies for Mitigating the Chances of a Recall Pharmacovigilance Definitions of Significant and Serious Adverse Events Recording, Investigating and Reporting Complaints FDA Communication Strategies for Dealing with Complaints Customs, Detentions and Import Alerts The Process Holds and Detentions Seizure and Destruction Remediating The Import Alert Rx Drug Promotion and Advertising Risk Considerations "Fair Balance" Elements & Considerations Brief Summary Boxed Warning Important Safety Information False and Misleading Claims Fair Balance Superiority Claims Testimonials Market Research Quality of Life Data Other Considerations Enforcement Action Examples Emerging Compliance Trends Counterfeit drug issues and growing concerns Drug shortage crisis Biosimilar approval pathways Others Other Compliance Issues Questions & Answers and Closing Thoughts For more information about this training visit About is the world's leading source for international market research reports and market data. 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