ICH - M14 Guideline Available for Comment

21st June 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.

Further to the ICH Management Committee’s endorsement of the M14 Concept Paper and Business Plan in April 2022, the M14 EWG was established to work on the development of the harmonised ICH M14 Guideline on General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines.

The guideline will focus on non-interventional pharmacoepidemiological studies using Real-World Data (RWD) and will include basic principles that may apply to these studies when real-world data elements are included. 

Further information can be found in the M14 Concept Paper and Business Plan.

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