Latest Regulatory Updates

The FDA announced appointments of key leaders to the Center for Drug Evaluation and Research (CDER), including a new Director, Deputy Director, and Directors for several divisions.

The ICH Assembly announced the admission of new members and observers, expanding its global network for harmonized technical requirements for pharmaceuticals.

The International Council for Harmonisation (ICH) announced that its Assembly Meeting will be held in Singapore in 2025 to discuss and advance international harmonization of technical requirements for pharmaceuticals.

The MHRA is conducting a stakeholder survey to gather feedback on the Health Institution Exemption (HIE) scheme, which allows healthcare institutions to use unlicensed medicines.

The MHRA is seeking feedback on the International Council for Harmonisation (ICH) guideline Q3E, which provides additional guidance on extractables and leachables risk assessment for pharmaceutical products.

This document outlines the MHRA's regulatory considerations for rare therapies, including approaches to accelerate access and promote innovation while ensuring patient safety and maintaining high standards.

The MHRA is consulting on proposed changes to the availability of puberty blockers for under 18s, aiming to ensure that prescribing decisions are aligned with recent court rulings and reflect a cautious approach considering the limited evidence regarding long-term effects.

The International Council for Harmonisation (ICH) has released training materials for Module 1 of ICH E6(R3) Addendum to the Guideline on Good Clinical Practice: Statistical Principles and Data Presentation, designed to assist sponsors in implementing the updated requirements.

The MHRA has published draft guidance outlining its approach to the regulation of individualised mRNA cancer immunotherapies, addressing key considerations for developers and providing clarity on the assessment process.

This report details the progress made in the first year of the UK's 5-year action plan to combat antimicrobial resistance, outlining achievements and future commitments across various sectors including human health, animal health, and environmental sustainability.

The ICH E2D(R1) guideline on clinical trial data, which addresses the principles of data integrity, has reached Step 4 of the ICH process, indicating it is available for adoption by regulatory authorities.

This consultation proposes changes to regulations, enabling greater flexibility for pharmacists in dispensing medicines and reducing administrative burdens while ensuring patient safety.

The International Council for Harmonisation (ICH) has published a presentation detailing Step 2 of ICH Q3E, which addresses impurities in novel biologics and provides guidance on their assessment.

The International Council for Harmonisation (ICH) has published training materials related to ICH E11A guidelines on nonclinical evaluation of radiopharmaceuticals, now accessible on the ICH website to support consistent application and understanding.

The ICH M14 guideline, concerning stability testing of new drug substances and products, has reached Step 4 of the ICH process, indicating it is available for adoption by regulatory authorities.

The MHRA is seeking views on how to prioritize designated standards for implementation, aiming to balance the need for robust regulatory frameworks with practical considerations and resource constraints within the UK pharmaceutical landscape.

This consultation proposes extending the scope of medicines that optometrists and contact lens opticians can supply, aiming to improve patient access and reduce pressure on general practitioners.

The MHRA is seeking feedback on proposals to adjust statutory fees for various regulatory functions, aiming to move towards ongoing cost recovery and ensure the sustainability of its operations.

This document outlines the MHRA's approach to ensuring a robust and resilient supply of medicines, focusing on proactive measures, risk mitigation strategies, and enhanced collaboration with stakeholders across the pharmaceutical supply chain.

The MHRA is conducting a call for evidence to explore the current regulatory framework and potential changes related to private (non-NHS) prescribing in the UK.