ICH to implement M14 Guideline for post-marketing safety submissions

The International Conference on Harmonisation (ICH) has recommended regulatory bodies of ICH regions adopt the final draft of the M14 Guideline, which aids sponsors with the post-marketing safety requirements for regulatory submissions.

As an internationally harmonised document, ‘General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise Real-World Data for Safety Assessment of Medicines’ acknowledges regional differences in real-world data (RWD) definitions and allowances for supplementary data, including primary data collection where appropriate.

Having reached Step 4 of the ICH process on 4 September via the Regulatory Members of the ICH Assembly, this guideline is now in the implementation phase of the ICH Process (Step 5).

Recommendations included in ICH’s M14 Guideline

While different ICH regions have slightly different definitions for RWD, the M14 guideline provides recommendations for the generation of real-world evidence (RWE) submitted for evaluation of post-marketing safety of medicines.

ICH’s guideline states that “RWD sources alone may be insufficient to answer the research question of interest and a study will require additional data for the purposes of the study. Because primary data collection may be relevant to non-interventional studies using RWD”. Therefore, the recommendations also include considerations for primary data collection.

“The process starts with articulating the study rationale and research question in response to a safety concern; then following a principled approach to identify the study population, exposure, comparator(s), outcome, and covariates; identifying the minimum data requirements to inform data source selection and guide feasibility assessment; assessing the representativeness of the data source to the target population; and considering sources of potential bias and confounding.”

Progressing it earlier this month, ICH announced the draft publication on Q3E drug impurities guideline on leachables. Opening it to public consultation, the guidelines are set to expand its frameworks for new medicinal products, including cell and gene therapies.