Evaluation of new medicinal products in the treatment of primary osteoporosis - Scientific guideline

This document provides guidance for the evaluation of new medicinal products in the treatment of primary osteoporosis, principally in postmenopausal women but also in men.

Keywords: Post-menopausal osteoporosis, osteopenia, bone mineral density, fractures

Current effective version

Guideline on the evaluation of medicinal products in the treatment of primary osteoporosis

Adopted Reference Number: CPMP/EWP/552/95 Rev. 2 Legal effective date: 31/05/2007

Document history - Revision 3

Concept paper on the need for revision of the guideline on the evaluation of medicinal products in the treatment of primary osteoporosis

Draft: consultation closed Consultation dates: 01/11/2012 to 31/01/2013 Reference Number: EMA/CHMP/520786/2012 Summary:

The proposed guideline will replace the guideline on the evaluation of medicinal products in the treatment of primary osteoporosis (CPMP/EWP/552/95 Rev. 2).

Document history - Revision 2

Guideline on the evaluation of medicinal products in the treatment of primary osteoporosis

Adopted Reference Number: CPMP/EWP/552/95 Rev. 2 Legal effective date: 31/05/2007

Overview of comments received on draft guideline on the evaluation of medicinal products in the treatment of primary osteoporosis

Reference Number: EMEA/CHMP/EWP/433354/2006

Draft guideline on the evaluation of medicinal products in the treatment of primary osteoporosis

Draft: consultation closed Reference Number: CPMP/EWP/552/95 Rev. 2