The European Medicines Agency EMA has released the ICH M14 guideline for public consultation. This guideline covers the general principles on planning, designing, and analysing pharmacoepidemiologic studies that use real-world data to assess the safety of medicines.

The use of these studies as evidence for regulatory decisions has grown globally, leading to the creation of multiple guidelines and best practice documents by health authorities and professional societies. Generating robust evidence for regulatory purposes depends on the quality of the data and the use of sound pharmacoepidemiologic methods.

The ICH M14 guideline offers internationally harmonized guidance and recommendations for conducting and analyzing non-interventional pharmacoepidemiologic studies using appropriate data to assess the safety of drugs, vaccines, and other biological products. It aims to streamline the development and regulatory assessment of study protocols and reports, facilitating their acceptance across various health authorities.1

Comments on the guideline should be submitted by August 30, 2024, using the provided template and sent to ich@ema.europa.eu.

Read the draft guideline here.

References

  1. European Medicines Agency, Committee for Human Medicinal Products, & International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2024). ICH M14 Guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m14-guideline-general-principles-plan-design-analysis-pharmacoepidemiological-studies-utilize-real-world-data-safety-assessment-medicines-step-2b_en.pdf

Disclaimers

  • The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
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