MAHs must use updated PI/FI templates for new submissions and variations, and incorporate the optional 'Gebrauchsanweisungen' section from 1 July 2026.
This change ensures that safety information and instructions for use are clearly presented, improving readability and user-friendliness for patients and healthcare professionals.
MAHs must ensure new medicinal product information texts use updated templates by 1 July 2026 and revise existing texts at the earliest opportunity if they include instructions for use.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
New optional section for instructions for use; updated templates must be used for new medicinal product information texts from 1 July 2026.
MAHs must use updated PI/FI templates for new submissions and variations to ensure appropriate presentation of safety information and instructions.
MAHs must ensure new medicinal product information texts use updated templates by 1 July 2026 and revise existing texts at the earliest opportunity if they include instructions for use.
Swissmedic mandates that updated templates for Patient Information and Information for Healthcare Professionals be utilized from 1 July 2026 for new submissions and variations. An optional section for instructions for use must be incorporated to enhance presentation and accessibility.
What changed: MAHs must use updated PI/FI templates for new submissions and variations, and incorporate the optional 'Gebrauchsanweisungen' section from 1 July 2026.
Why it matters: This change ensures that safety information and instructions for use are clearly presented, improving readability and user-friendliness for patients and healthcare professionals.
Practical implication: MAHs must ensure new medicinal product information texts use updated templates by 1 July 2026 and revise existing texts at the earliest opportunity if they include instructions for use.
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.
MAHs and sponsors must enhance their pharmacovigilance systems to monitor microbiome-specific safety issues, comply with established safety standards, and address concerns related to antimicrobial resistance.
Stakeholders, including manufacturers and clinicians, must review and potentially revise their post-market vigilance and safety monitoring protocols in response to the FDA's proposed regulatory approaches for generative AI devices.
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.
