WHO Drug Information Vol. 19, No. 2, 2005
(2005; 98 pages) View the PDF document
Table of Contents
Open this folder and view contentsBiomedicines Update
Open this folder and view contentsSafety and Efficacy Issues
Open this folder and view contentsRegulatory Action and News
Open this folder and view contentsCurrent Topics
Open this folder and view contentsATC/DDD classification
Close this folderRecent Publications and Sources of Information
View the documentSources and prices of malaria medicines and products
View the documentLaunch of a searchable online database of adverse reactions
View the documentNewly-published European Union guidelines
Open this folder and view contentsThe International Pharmacopoeia
View the documentInternational Nonproprietary Names for Pharmaceutical Substances (INN)
 

Newly-published European Union guidelines

Common Technical Document (CTD) format: adopted guidelines

CHMP/EWP/252/03
Guideline on clinical investigation of medicinal products intended for the treatment of neuropathic pain. Effective: 1 June 2005

CPMP/BWP/5180/03
Guideline on assessing the risk for virus transmission - new chapter 6 of the note for guidance on plasma - derived medicinal products (CPMP/ BWP/269/95). Effective: 20 May 2005

CPMP/EWP/788/01
Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Migraine. Effective: 20 May 2005

CPMP/EWP/2863/99
Points to Consider on Adjustment for Baseline Covariates. Effective: 20 May 2005

CPMP/EWP/3020/03
Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders. Effective: 20 May 2005

CPMP/BWP/CPMP/5136/03
Guideline on the investigation of manufacturing processes for plasma-derived medicinal products with regard to VCJD risk. Effective: 12 May 2005

EMEA/CPMP/3097/02
Guideline on Comparability of Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. Effective: 12 May 2005

CPMP/EWP/612/00
Note for Guidance on Clinical Investigation of Medicinal Products for Treatment of Nociceptive Pain. Effective: 12 May 2005

EMEA/CPMP/BWP/3207/00, rev 1
Guideline on Comparability of Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues. Effective: 2 May 2005

CPMP/SWP/2599/02, rev 1
Position Paper on Non-Clinical Safety Studies to Support Clinical Trials with a Single Microdose. Effective: 2 May 2005

EMEA/CPMP/BWP/3794/03
Guideline on the Scientific Data Requirements for a Plasma Master File (PMF). Effective: 18 February 2005

Available from: http://www.emea.eu.int/whatsnewp.htm

 

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Last updated: April 24, 2012