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GLOBAL REGULATORY AFFAIRS SPOTLIGHTS

Pharmacogenomics Guideline Issued: E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories. Sources: ICH and US FDA. EU: Approved by CHMP in November 2007, date for coming into operation: May 2008; MHLW: Adopted January 9, 2008, PFSB/ELD Notification 0109013 & PFSB/SD Notification 0109002; FDA: Published in the Federal Register, Vol.73,n°68, pages 19074-19076; April, 8, 2008. This is a guideline which reflect the current thinking of these agencies and, therefore, are not regulations at this point in time...... Details .... More ..

EMEA Standard Operating Procedures (SOP) and Work Instructions (WIN). A new SOP has been published, or an existing one has been updated, please go to More details..

Egypt approves commercialisation of first GM crop. Source: SciDev.net - By Wagdy Sawahel; 13 May 2008. CAIRO, Egypt- Egypt has approved the cultivation and commercialisation of a Bt maize variety, marking the first legal introduction of genetically modified (GM) crops into the country.

Egypt currently has no official biosafety legislation, though a regulatory framework exists. Hisham El-Shishtawy from the National Biosafety Committee secretariat told SciDev.Net that the existing framework follows the Cartagena Protocol on Biosafety and encompasses ministerial decrees regulating the registration of GM seeds. More ...