News in Brief
The European Commission has dodged a demand from the European Parliament for a timetabled phase-out of all scientific experiments on primates. MEPs also want a ban on experiments on wild-caught monkeys and apes as an "urgent priority". But a Commission reply merely stressed that for EU-funded research the "use of available alternatives [to animals] is always compulsory".
The European Commission has dodged a demand from the European Parliament for a timetabled phase-out of all scientific experiments on primates. MEPs also want a ban on experiments on wild-caught monkeys and apes as an "urgent priority". But a Commission reply merely stressed that for EU-funded research the "use of available alternatives [to animals] is always compulsory".
The European Medicines Agency (EMEA) has advised that prescriptions of pain killing medicines containing nimesulide should be limited to a maximum of 15 days and that packs containing more than 30 doses (tablets or sachets) should be banned. The European Commission will now consider making this recommendation compulsory. It follows concerns that nimesulide causes liver problems.
EMEA has released a guideline on developing medicines from allergens - www.emea.europa.eu/pdfs/human/bwp/30483107en.pdf.
It has also released comments received on a draft guideline on requirements for first-in-man clinical trials for potential high risk medicinal products - www.emea.europa.eu/pdfs/human/swp/29519007en.pdf.
And EMEA has created an emerging medicine science section on its website -www.emea.europa.eu/htms/human/mes/introduction.htm.
Meanwhile, the European Commission has released amended GMP guidance for pharmaceuticals to take account of new advanced therapy and biological medicinal products - http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/
doc2007/2007_09/gmp_annex_2_consultation_2007_08_13.pdf.