NCSC Assessment: Impact of AI on Cyber Threats 2027

The UK's National Cyber Security Centre (NCSC) has released an assessment detailing how Artificial Intelligence (AI) is expected to significantly increase cyber threats by 2027. The report highlights that AI will make intrusion operations more effective and efficient, potentially leading to a digital divide in system vulnerability.

NCSC Report: AI to Increase Cyber Attack Volume and Impact

The UK's National Cyber Security Centre (NCSC) has released a report assessing the near-term impact of Artificial Intelligence on the cyber threat. The assessment concludes that AI will almost certainly increase the volume and impact of cyber attacks over the next two years, though the effect will be uneven across different threat actors.

Active Cyber Defence Programme - Sixth Year Report

The UK's National Cyber Security Centre has published the sixth-year report on its Active Cyber Defence (ACD) programme. The report details findings on how the programme has protected the UK from cyber attacks since its launch in 2017.

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.

EU-PIC/S GMP Annex 3 Revision Concept Paper Released

The EMA and PIC/S have released a concept paper proposing revisions to Annex 3 of the EU-PIC/S GMP Guide concerning the manufacture of radiopharmaceuticals. This consultation period runs until February 15, 2026, and aims to update guidance to reflect current practices and innovative approaches.

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 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.

Class 3 Medicines Recall: Bayer Plc, Various Products

Bayer Plc is recalling specific batches of Gastrografin, Urografin 150 Solution, and Urografin 150 Injection due to an impurity exceeding acceptable limits. This recall is a precautionary measure at the pharmacy and wholesaler level.

Field Safety Notices Issued March 2-6, 2026

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a list of Field Safety Notices (FSNs) issued between March 2 and March 6, 2026. These notices detail safety concerns and required actions for specific medical devices, including those from ArjoHuntleigh, BD, Cook, Löwenstein, and OXOID.