MHRA
MHRA updates UK marketing authorisation application guidance
The guidance outlines the process for obtaining a UK marketing authorisation, including application submission, fast tracking, medicine naming and fees.
Read the official sourceMHRA
Current electronic application forms remain available
MHRA published current electronic application forms for UK medicines licensing applications. Existing submission routes, validation requirements and assessment processes remain unchanged.
Read the official sourceMHRA
MHRA updates work sharing initiative guidance
The guidance covers applications for new active substance and biosimilar work sharing assessments and provides a list of approved products.
Read the official sourceMHRA
MHRA publishes September 2026 advertising decisions
MHRA released decisions concerning advertisements reported as potentially breaching medicines advertising legislation.
Read the official sourceFDA
FDA submits Voluntary Improvement Program collection for OMB review
FDA announced that the proposed information collection has been submitted to OMB for review and clearance under the Paperwork Reduction Act.
Read the official sourceFDA
FDA seeks advisory committee consumer nominations
FDA requested nominations for consumer representatives and invited consumer organizations to participate in selecting representatives for advisory committees and panels.
Read the official sourceWhy this matters
Regulatory teams working in the UK should check current licensing instructions, forms and work sharing guidance while noting that core electronic submission processes remain unchanged. The advertising decisions also provide current examples of MHRA enforcement. In the United States, the FDA notices concern program information collection and participation in advisory committee processes.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.