1. EMA outlines changes to signal management, PSUR assessment and the RMP template
On 3 November EMA published the highlights of its 21st industry platform meeting on the operation of EU pharmacovigilance legislation, held on 20 October. Under revision 2 of GVP Module IX, marketing authorisation holders no longer have to continuously monitor EudraVigilance or send standalone validated-signal notifications; monitoring frequency must instead be risk-proportionate and documented, and where a signal assessment concludes that the product information should change, the variation should be submitted no later than three months after signal validation. EMA also plans, subject to PRAC endorsement, a voluntary 2027 pilot in which companies pre-fill factual sections of PSUSA assessment report templates, and intends to request summary tabulations and case tables in Excel format for all PSUSA procedures from early 2027. Separately, the draft GVP Module V and RMP template have gone back to the drafting group to align with the expected new pharmaceutical legislation, which EMA expects to delay the public consultation by about six months. Signal management SOPs and PSUR planning for 2027 are the obvious places to check against these changes. EMA industry platform highlights, published 3 Nov 2026
2. One year of EudraVigilance ICSR compliance reports: where companies fall short
The same EMA highlights review the first year of monthly ICSR compliance reports, which are generated through EVDAS and sent to registered QPPVs and responsible persons for the 7-, 15- and 90-day reporting timelines. Average industry compliance from 1 October 2025 to 30 September 2026 was 96.57% for 15-day and 98.17% for 90-day post-marketing reporting, and 97.31% for fatal or life-threatening clinical trial cases. The recurring problems EMA identified were missing or late QPPV registration, uncertainty about sender identifiers, differences between companies' internal submission counts and EudraVigilance records, and poor communication between QPPVs, case-processing teams, CROs and IT. An EVDAS query to help companies reconcile their submitted ICSRs is under development, and EMA has committed to a more detailed breakdown of compliance at its 1 December 2026 multi-stakeholder forum. EMA industry platform highlights, published 3 Nov 2026
3. FDA finalises potency assurance guidance for cell and gene therapies
FDA issued final guidance on 2 November recommending a science- and risk-based potency assurance strategy for cellular and gene therapy products, replacing its 2011 potency testing guidance. The recommendations run from early IND submissions through BLA approval and post-approval verification, and cover raw-material variability, in-process testing, batch-release assays that reflect the intended biological activity, and special cases such as short-shelf-life, viral-vector and patient-specific products. For safety teams, batch-level potency and its traceability matter when investigating lot-related clusters of adverse events or lack of efficacy, which are a recurring theme in cell therapy programmes. FDA will hold a webinar on the guidance on 10 December 2026. FDA press release, 2 Nov 2026
4. Health Canada announces Type I recall of a cyclophosphamide injection lot
Health Canada published a national Type I recall on 2 November for one lot (7Z10346A) of Marcan Pharmaceuticals' Cyclophosphamide for Injection USP, 1,000 mg/vial (DIN 02560216), because of particulate matter in the lot. The recall reaches healthcare establishments, and Type I is Health Canada's highest-risk recall class. For pharmacovigilance teams, recalls of parenteral cytotoxics are a prompt to check whether any adverse event reports, such as infusion reactions or embolic events, are linked to the affected lot, and to make sure lot numbers are captured in case intake. Health Canada recall notice, 2 Nov 2026
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