Revised FDA Guidance on ANDA and 505(b)(2) Application Submission
Implement a gap analysis for 505(b)(2) applications to identify safety data needs and adjust safety monitoring systems as necessary to accommodate new product characteristics.
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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Review in the next regulatory intelligence cycle.
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.
Implement a gap analysis for 505(b)(2) applications to identify safety data needs and adjust safety monitoring systems as necessary to accommodate new product characteristics.
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Developers of MBMPs must align their safety assessment protocols with the MHRA's expectations and are encouraged to engage with the MHRA early to establish appropriate regulatory strategies.