International

PIC/S EU GMP Guides: Consultation on Documentation, AI, and Computerised Systems

PIC/S and the European Commission have launched a joint stakeholder consultation on revisions to the EU GMP Guides, specifically Chapter 4 (Documentation) and Annex 11 (Computerised Systems), and a new Annex 22 on Artificial Intelligence. The consultation period runs from July 7, 2025, to October 7, 2025.

PIC/S GMP Annex Revisions and Membership Applications

The EMA and PIC/S have released concept papers for revisions to GMP Annex 15 (Qualification and validation) and Annex 6 (Manufacture of medicinal gases). These documents are open for public consultation until April 2026. Additionally, Kazakhstan has applied for PIC/S membership.

PIC/S GMP Guide Revisions and Membership Updates

The EMA and PIC/S have released concept papers for public consultation on revisions to EU-PIC/S GMP Annex 6 (Manufacture of medicinal gases) and Annex 15 (Qualification and validation). These revisions aim to update guidelines to reflect current industry practices, new technologies, and ICH Q9(R1). Kazakhstan has also applied for PIC/S membership.

PIC/S EU GMP Guide Revision of Chapter 1 on Pharmaceutical Quality System

The European Commission and PIC/S are jointly consulting on a revision to Chapter 1 of the EU GMP Guide concerning Pharmaceutical Quality Systems. The update aligns with ICH Q9(R1) on Quality Risk Management and aims to enhance regulatory frameworks, ensure medicine quality, and mitigate supply chain risks.

WHO Handbook Accelerates Hepatitis Elimination Action

The World Health Organization (WHO) has released a new implementation handbook to support countries in accelerating action towards hepatitis elimination by 2030. The handbook consolidates evidence-based recommendations and provides practical guidance for expanding prevention, testing, and treatment services.

WHO Releases New Antibiotic Profiles for Drug-Resistant Infections

The World Health Organization (WHO) has released three new Target Product Profiles (TPPs) for antibacterial agents to address critical drug-resistant infections. These profiles guide the development of new antibiotics for multidrug-resistant Gram-negative infections, Gram-positive infections in vulnerable patients, and bacterial meningitis.

Public Responses to Insurer Recovery and Resolution Planning Consultation

The Financial Stability Board (FSB) has published public responses to its consultation on the scope of insurers subject to recovery and resolution planning requirements. The consultation period closed on February 6, 2026, and the FSB expects to publish final guidance in Q2-Q3 of 2026.

FSB Report on Repo Market Vulnerabilities

The Financial Stability Board (FSB) has released a report warning of vulnerabilities in government bond-backed repo markets. The report highlights potential contagion channels and emphasizes the need to preserve market functionality during stress periods, offering policy implications for regulators.

FSB 2026 Work Programme: Financial Stability and Systemic Risks

The Financial Stability Board (FSB) has published its work programme for 2026, outlining key priorities to promote global financial stability. The programme focuses on addressing systemic risks through vulnerability assessments, nonbank financial intermediation, cross-border payments, digital innovation, and operational resilience.

FSB Peer Review: Public Sector Backstop Funding Mechanisms

The Financial Stability Board (FSB) is conducting a thematic peer review on public sector backstop funding mechanisms and has issued a summary of terms of reference. The FSB is seeking feedback from financial institutions and other stakeholders by March 31, 2026, to inform its review of implementation progress.