International

ICH Guidelines Overview

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines across quality, safety, efficacy, and multidisciplinary areas. These guidelines aim to harmonize technical requirements for pharmaceutical registration globally.

ICH Q1A(R2) Stability Testing Guideline Finalized

The International Council for Harmonisation (ICH) has finalized its Q1A(R2) guideline on stability testing of new drug substances and products. This revised guideline, effective February 6, 2003, provides updated recommendations for stability testing protocols across different climatic zones.

PCI SSC Establishes India-South Asia Regional Engagement Board

The PCI Security Standards Council (PCI SSC) has established its first Regional Engagement Board (REB) for the India and South Asia region, effective for 2025-2026. The board comprises 27 organizations from the payment industry to advise on payment security issues and promote awareness of PCI SSC standards.

PCI SSC Asia-Pacific Community Meeting on Payment Security

The PCI Security Standards Council (PCI SSC) is hosting its annual Asia-Pacific Community Meeting in Bangkok on November 5-6, 2025. The event will bring together payment security experts to discuss evolving threats, new technologies, and best practices for preventing cyberattacks and fraud in the region.

PCI Security Standards Council Publishes Inaugural Annual Report

The PCI Security Standards Council has released its first-ever Annual Report, detailing progress in payment security during 2025 and outlining its vision for 2026. The report highlights advancements in standards, global collaboration, and the adoption of a product-led operating model.

PCI SSC Meeting Advances Payment Security and AI Guidance

The PCI Security Standards Council held its North America Community Meeting, focusing on advancing payment security and launching AI guidance. The event brought together over 1,200 stakeholders to discuss evolving standards, best practices for AI in payments, and cross-industry collaboration.

EU AI Act Omnibus: New Compliance Deadlines and Deepfake Ban

Members of the European Parliament have reached a preliminary agreement on amendments to the EU AI Act, including extended compliance deadlines for high-risk systems and a ban on non-consensual deepfakes. The agreement aims to provide legal certainty and allow more time for technical standards and guidance development.

US House Committee Advances KIDS Act and Other Online Safety Bills

The U.S. House Committee on Energy and Commerce advanced the KIDS Act, Sammy's Law, and the App Store Accountability Act to a full House vote. These bills aim to enhance children's online safety by addressing issues like dangerous content, age verification, and app store policies.

Maine Privacy Bill Advances, Oregon AI Chatbot Bill Clears Legislature

Maine's legislature has advanced a comprehensive privacy bill, the Maine Online Data Privacy Act, through both chambers. Oregon's Senate Bill 1546, an AI chatbot safety bill, has also cleared its state legislature and is heading to the governor. Both bills represent significant state-level regulatory developments.

AI Training Compliance Guidance Post-SRB Ruling

This guidance analyzes the impact of the EU Court of Justice's Single Resolution Board ruling on AI training compliance for engineers. It outlines two pathways for compliance, emphasizing engineering choices in defining identifiability and data protection.