ICH M4Q(R2) Public Consultation
Published 12 August 2025
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The new ICH M4Q(R2) guideline will revise and update the current ICH M4Q(R1) guidelines.
The introduction of the M4Q(R1) guidelines on the Common Technical Document (CTD) in 2002 harmonised the format of quality information for registration of pharmaceuticals for human use and offered great benefits to industry, regulators, patients, and consumers. M4Q(R1) is now due for revision to further improve registration and lifecycle management efficiency, leverage digital technologies, and accelerate patient and consumer access to pharmaceuticals.
The focus of M4Q(R2) is the revision of CTD Quality sections in Modules 2 and 3 to capture quality information for the registration and lifecycle management of pharmaceuticals for human use. The M4Q(R2) guideline would speed up patients and consumers’ access to pharmaceuticals while being of great benefit to both industry and regulatory agencies.
For patients and consumers, it would ensure rapid and continuing access to new products by bringing a streamlined and consistent approach to the registration and lifecycle management of pharmaceuticals.
For industry, it would clarify regulatory expectations, facilitate applying the enhanced ICH quality strategy/vision, streamline regulatory application preparation, improve the quality of submissions, facilitate data and information management, promote communication with regulators, and foster harmonisation and standardisation of data/information requirements for regulatory submissions, while increasing regulatory convergence.
For regulators, it would enhance benefit-risk considerations, increase access to quality data and information, streamline regulatory assessment, facilitate oversight of pharmaceutical product quality, increase consistency and efficiency in regulatory decision-making and actions, and improve communication with industry and among regulators.
The MHRA welcomes views on the draft guideline from all UK stakeholders including patients and the public. You can provide comments and recommendations to the consultation as an individual or on behalf of an organisation (one response per organisation please) using the ICH Public Consultation Comments template and emailing it to ichconsultations@mhra.gov.uk. Please include ‘M4Q(R2) consultation’ in the subject line of your email.
Following the consultation, feedback from the stakeholders within the UK and other ICH regions will be reviewed and discussed by the ICH M4Q(R2) EWG directly. We do not intend to publish a full response to this consultation, as we are not required to for this type of consultation.
Background
The Medicines and Healthcare products Regulatory Agency (MHRA) became a full member of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in May 2022. ICH brings together global regulators and the pharmaceutical industry to achieve the harmonised development of safe, effective and high-quality medicines.