News in Brief
- The European Commission has hailed a success its five-year-old system promoting the development of orphan drugs, noting 22 medicines for rare diseases have now received EU marketing authorisation. A further 270 potential treatments have been designated as orphan medicinal products undergoing clinical tests.
- The European Commission has hailed a success its five-year-old system promoting the development of orphan drugs, noting 22 medicines for rare diseases have now received EU marketing authorisation. A further 270 potential treatments have been designated as orphan medicinal products undergoing clinical tests.
- The EU Council of Ministers has authorised the Commission to negotiate an agreement with China that would enable both sides to co-operate in fighting the trade in chemical precursors used to make illicit drugs. Some of these are key ingredients used in the pharmaceutical sector. The deal is expected to involve information and intelligence exchanges.
- An EU research project has identified a series of opportunities for further studies that ally the techniques of biomedicine and informatics. The SYMBIOmatics project has released a list of such potential advances, including developing medical genetics databases; collating gene expression information in medical diagnostics and prognostics; and modelling biological structures, processes and diseases. www.symbiomatics.org
- The European Medicines Agency (EMEA) has issued guidelines on the limits of genotoxic impurities in EU medicines (www.emea.eu.int/pdfs/human/swp/519902en.pdf).It has also released guidelines on reporting the results of population pharmacokinetic analyses (www.emea.eu.int/pdfs/human/ewp/18599006en.pdf) and on the role of pharmacokinetics in developing children's medicines (www.emea.eu.int/pdfs/human/ewp/14701304en.pdf).
- EMEA has published guidance on detecting early signals of drug-induced hepatotoxicity in non-clinical studies (www.emea.eu.int/pdfs/human/swp/15011506en.pdf).
- Meanwhile, the European Commission has issued draft guidance on non-commercial clinical trials ( http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2006/07_2006/guide_noncommercial_2006_07_27.pdf), and it has released advice on de-scribing excipients in marketing applications (http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-3/pdfs-en/3aq9aen.pdf).