Saudi Arabia Seeks Feedback on Good Pharmacovigilance Practices Terminology

The Saudi Food and Drug Authority is seeking feedback on a proposed list of definitions for terms associated with good pharmacovigilance practices.

The terms range from adverse drug reaction report and incident to periodic safety update report, risk management plan, validated signal and more. Definitions follow European Union implementing regulations and directives, as well as guidelines from the World Health Organization, International Conference on Harmonisation and International Organization for Standardization.

The 35-page draft guideline, released last week, will be implemented June 27. Comments are being accepted. Read it at www.fdanews.com/05-15-SFDA-GVP.pdf. — Jonathon Shacat