Updates on ISO 14155 and N=1 Therapeutics Discussed by TGA
Investigators need to modify trial protocols and safety reporting mechanisms in line with the latest ISO 14155 updates to ensure compliance for upcoming high-risk clinical trials.
Primary source: Health Sciences Authority (HSA) Singapore
The extension of the e-labelling scheme to include Pharmacy-only (P) and General Sale List (GSL) medicines effective from 30 June 2026.
This initiative enhances digital access to product information and safety updates, thus improving the labeling workflows and requiring updates to registration and packaging processes for Marketing Authorization Holders (MAHs).
Manufacturers must adjust labeling workflows to incorporate e-labelling mechanisms, such as QR codes, for P and GSL medicines by the stipulated date.
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Extension of the e-labelling scheme to include P and GSL categories of therapeutic products. Manufacturers and registration holders can now provide product information through digital means (e.g., QR codes) instead of or in addition to physical leaflets for these categories.
Improved accessibility to the latest product information and safety updates for healthcare professionals and consumers. This affects labeling workflows and requires updates to registration and packaging processes for MAHs.
Manufacturers must adjust labeling workflows to incorporate e-labelling mechanisms, such as QR codes, for P and GSL medicines by the stipulated date.
This regulatory update mandates that manufacturers and registration holders can provide product information through digital means, such as QR codes, for Pharmacy-only and General Sale List medicines, leading to improved accessibility for healthcare professionals and consumers.
What changed: The extension of the e-labelling scheme to include Pharmacy-only (P) and General Sale List (GSL) medicines effective from 30 June 2026.
Why it matters: This initiative enhances digital access to product information and safety updates, thus improving the labeling workflows and requiring updates to registration and packaging processes for Marketing Authorization Holders (MAHs).
Practical implication: Manufacturers must adjust labeling workflows to incorporate e-labelling mechanisms, such as QR codes, for P and GSL medicines by the stipulated date.
Published from the Firecrawl policy change extraction pipeline.
Investigators need to modify trial protocols and safety reporting mechanisms in line with the latest ISO 14155 updates to ensure compliance for upcoming high-risk clinical trials.
Safety lead to: (1) perform a UK-clinical-trial safety reporting gap assessment against MHRA’s effective guidance sections (MedDRA coding; AE/SAE; RSI governance; SUSARs; annual safety reporting; USMs; serious breaches; temporary suspension), (2) update controlled SOPs/WIs and training records to reflect “effective” status as of 28 Apr 2026, and (3) document deviations/gaps and open CAPA where needed for ongoing UK trials and new submissions.
Sponsors and MAHs must review and align safety data collection and reporting protocols with the newly adopted guidelines while preparing for implementation of PRAC recommendations stemming from this meeting.
Healthcare facilities must utilize the new checklist during inspections to conduct gap analyses and ensure compliance with reporting requirements associated with their vigilance systems.