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ICH Guidance: M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines

FDA (FDA or Agency) has announced the availability of a draft guidance for the industry called “M14 General Principles on Planning, Designing, and Analyzing Pharmacoepidemiological Studies Utilizing Real-World Data for Drug Safety Assessment”. The draft guidelines were prepared by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).


Pharmacoepidemiological studies are a branch of epidemiology that focus on understanding the use, effectiveness, and safety of pharmaceuticals in large, well-defined populations. These studies apply the principles and methods of epidemiology to the content area of clinical pharmacology, thus bridging the gap between clinical research and public health.


This guidance provides comprehensive principles on the planning, design, and analysis of pharmacoepidemiological studies that utilize real-world data (RWD) for assessing the safety of medicines. The aim is to ensure that such studies are robust, reliable, and provide meaningful safety information.

This draft guidance provides general guidelines for planning, designing, and analyzing observational (noninterventional) pharmacoepidemiological studies for assessing the safety of medicines (drugs, vaccines, and other biological products) by utilizing fit-for-purpose data. This draft guidance includes high-level best practices and recommendations for conducting these studies.


This draft guidance aims to streamline the development of postmarketing pharmacoepidemiological safety studies that incorporate Real-World Data and the regulatory assessment of those studies. As part of this guidance, health authorities will be more likely to accept study protocols and/or results and support decision-making in response to study results.

The M14 guideline underscores the importance of rigorously designed and conducted pharmacoepidemiological studies using RWD for drug safety assessment. Adhering to these principles enhances the reliability and validity of study findings, ultimately contributing to improved patient safety and public health outcomes.


To more in detail about the General principles, framework, Protocol developments, etc click here.

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