By a News Reporter-Staff News Editor at Drug Week -- Current study results on Drug Development have been published. According to news reporting originating from Quedlinburg, Germany, by NewsRx correspondents, research stated, "In this article, the general principles of genetically modified (GM) plant risk assessment and the regulatory framework for contained use and open field production of plant-made pharmaceuticals/plant-made industrials (PMP/PMI) are described. While significant progress has been made for the containment grown (plant cell culture) production of PMPs, with the first regulatory approval made by the FDA in 2012, the commercialization of medicinal or industrial products produced in the field has yet to emerge in either Europe or the US."
Our news editors obtained a quote from the research from Julius Kuhn Institute, "In the current paper, we discribe the regulatory environment in Europe and the US surrounding GM crops, and provide case studies for experimental field releases of PMP and PMI producing plants in both regions. Suggestions for reducing the regulatory burden for GM plants will be discussed, also in light of the emerging new technologies to modify the genetics of plants. Since regulations surrounding the commercialization of GM crops are very costly and not appropriate for most of the PMP/PMI applications in Europe, we propose that amendments to the EU Directive 2001/18/EC are necessary to allow for the commercialization of products from GM plants without the need of an 'authorization."
According to the news editors, the research concluded: "To fully acknowledge the overall outcome of adopting plants to produce PMP/PMI, the conclusion is that broader and more balanced legislative oversight is needed in Europe; while specific legislation is not needed in the US."
For more information on this research see: Risk Assessment and Regulation of Molecular Farming - A Comparison between Europe and US. Current Pharmaceutical Design, 2013;19(31):5513-5530. Current Pharmaceutical Design can be contacted at: Bentham Science Publ Ltd, Executive Ste Y-2, PO Box 7917, Saif Zone, 1200 Br Sharjah, U Arab Emirates. (Bentham Science Publishers - www.benthamscience.com; Current Pharmaceutical Design - www.benthamscience.com/cpd/index.htm)
The news editors report that additional information may be obtained by contacting P. Sparrow, Julius Kuhn Inst, Fed Res Center Cultivated Plants JKI, Inst Biosafety Plant Biotechnol, D-06484 Quedlinburg, Germany. Additional authors for this research include I. Broer, E.E. Hood, K. Eversole, F. Hartung and J. Schiemann (see also Drug Development).
Keywords for this news article include: Europe, Germany, Quedlinburg, Legal Issues, Drug Development
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