Latest Regulatory Updates

The MHRA is seeking feedback on the revised ICH guideline M4Q(R2) concerning statistical principles for clinical trials, which aims to harmonize expectations across regulatory authorities regarding data analysis and reporting.

This consultation proposes a licensing scheme for non-surgical cosmetic procedures in England, aiming to improve standards and patient safety by regulating practitioners and premises.

The International Council for Harmonisation (ICH) has released a draft guideline, Q3E, addressing genotoxicity assessment of gene therapy products and related biological therapies, available for public review and comment on the ICH website.

This consultation proposes extending the legal responsibilities of allied health professionals (AHPs) regarding medicines, aiming to clarify their roles and accountabilities in prescribing, dispensing, and administering medications within the UK.

This document provides an update on the MHRA's progress in transforming the UK clinical research system, outlining key milestones and initiatives aimed at attracting more innovative medicines and therapies to the UK.

The ICH E2B(R3) Q&As, Implementation Guide, and Appendix I (G) have reached Step 4 of the ICH process, indicating near finalization and potential for adoption by regulatory bodies worldwide.

The International Council for Harmonisation (ICH) has published a presentation detailing Step 2 of ICH E20, which provides guidance on the implementation of clinical data standards for submissions.

The International Council for Harmonisation (ICH) has published training materials related to ICH Q2(R2) and Q14 guidelines on the ICH website, aimed at supporting understanding and implementation of these quality standards.

The International Council for Harmonisation (ICH) has published a Step 2 presentation of ICH M4Q(R2), which provides updated guidance on quality considerations for clinical trials, now available on the ICH website.

The International Council for Harmonisation (ICH) has released a draft guideline, E20 on Reaching Agreement on Registrational Data Submitted to Regulatory Authorities, for public consultation and feedback.

The International Council for Harmonisation (ICH) has published a presentation detailing Step 2 of the ICH E21 guideline, which provides additional guidance on renal impairment data in clinical study submissions.

The International Council for Harmonisation (ICH) announced its upcoming Assembly Meeting will be held in Madrid, Spain, in 2025 to continue discussions and progress on harmonized technical guidelines for pharmaceutical product registration.

The International Council for Harmonisation (ICH) has released ICH Q5(R2), which provides updated guidance on the viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, harmonizing expectations across regulatory regions.

The International Council for Harmonisation (ICH) has released a draft guideline and Step 2 presentation for ICH Q1, addressing threshold of toxicological concern (TTC), for public consultation on the ICH website.

The International Council for Harmonisation (ICH) received the Outstanding Contribution to Health Award at the DIA Europe meeting in Basel, recognizing its ongoing efforts in standards development and international harmonization of technical requirements for pharmaceuticals.

The International Council for Harmonisation (ICH) has announced that the eCTD v4.0 Q&A v1.9 document has reached Step 4 of the ICH process, indicating it is nearing completion and potential adoption by regulatory bodies.

The International Council for Harmonisation (ICH) has published an updated technical specification Step 2 presentation for ICH M11, providing guidance on the generation of quantitative structure-activity relationship (QSAR) models for drug development.

The International Council for Harmonisation (ICH) has released a draft guideline and Step 2 presentation for ICH M13B, addressing clinical data requirements for registration of new medicines, now available for public review on the ICH website.

The International Council for Harmonisation (ICH) has released an updated Technical Specification Document for ICH M11, providing guidance on developmental toxicity studies in support of registration applications.

The International Council for Harmonisation (ICH) has published an introductory training presentation to support understanding and implementation of the revised ICH E6(R3) guideline on Good Clinical Practice - Integrated Addendum to Guideline E6(R1).