Discover key regulatory updates from the week of November 18th in medical devices, IVD, SaMD, pharmaceuticals, biotech, and combination products, as recognised by the Global Index powered by Hoodin. This edition highlights top regulatory news and analyses, featuring updates from MHRA (UK) on a new pathway supporting innovative medicine development and FDA (US) on an extended input period for enhancing post-market safety assessments of food-related chemicals.
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Top Picks for November 18th - November 24th
Innovative Licensing and Access Pathway MHRA Published Nov 20
Europe | PHARMACEUTICAL | BIOTECH | COMBINATION PRODUCTS
SUMMARY MHRA announces the closure of applications under the current Innovative Licensing and Access Pathway (ILAP) as of 20 November 2024. A refreshed pathway will open for applications in March 2025 to enhance support for innovative medicine development.
IMPLICATIONS: Transition Planning: Companies currently preparing applications must adjust timelines and align with the upcoming pathway opening in March 2025.
Preparation for Changes: Developers may need to review and adapt to new criteria or processes introduced with the refreshed pathway.
Opportunity for Innovation: The new pathway is expected to offer improved mechanisms to support innovative medicine development, potentially benefiting long-term access strategies.
Development of an Enhanced Systematic Process for the Food and Drug Administration's Post-Market Assessment of Chemicals in Food; Public Meeting; Request for Comments; Extension of Comment Period
FDA | Published Nov 21
North America | PHARMACEUTICAL | BIOTECH | MEDICAL DEVICES | IVD
SUMMARY
The FDA’s enhanced systematic process for post-market assessment of chemicals in food is designed to improve safety evaluations for chemicals used in food and food-contact products. The process includes an extended comment period, allowing stakeholders to provide input on the proposed framework aimed at strengthening post-market safety assessments
IMPLICATIONS:
Extended Comment Period: Stakeholders now have more time to review and provide input on the proposed changes to safety evaluation processes.
Impact on Food-Contact Products: Companies manufacturing products in contact with food will need to assess how the updated framework could affect their safety assessments and regulatory compliance.
Enhanced Safety Evaluation: The new process aims to improve the post-market surveillance and safety of chemicals, potentially leading to more stringent regulatory requirements for food-related chemicals.
* Top picks may not be the biggest news, as those updates might have already reached you. Instead, the top picks highlight the most important developments for key players in the life sciences industry that you may have missed during the week.
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