Organizations involved in medical device compliance should prepare for potential future changes requiring MHRA-issued licenses for devices entering the market.
Pharmaceutical companies should prepare to assess the impact of hepatic impairment early in drug development, particularly for drugs that require pharmacokinetic assessments.
Update internal systems and workflows to integrate monthly Excel reports from EMA starting March 2025, ensuring timely capture of information on medicines under evaluation and any extension applications.
Regulatory Intelligence leads should initiate monitoring of feedback and prepare for potential regulatory adjustments related to the specified substances.
Small business dispensers are encouraged to complete a mandatory assessment survey by September 22, 2026, and do not need to submit information to the FDA while utilizing these exemptions.
Stakeholders are advised to submit comments on the draft guidance by 11/18/2026, using docket number FDA-2026-D-8561 to ensure FDA considers their feedback before finalizing the document.
Innovators must now utilize the Innovation Accelerator for access to regulatory expertise and guidance on pharmacovigilance and risk management strategies.
Stakeholders, including those involved in labeling and signal management, should consider the published comments to align future processes with the regulatory expectations detailed in the draft ICH E22 guideline.
