Biosafety, Risk Assessment and Regulation of Plant-Made Pharmaceuticals
The technology for plant-made pharmaceuticals (PMPs) has progressed significantly over the last few years, with the first commercial products for human use expected to reach the market by 2009 (see Note 1). As part of the ‘next generation’ of genetically modified (GM) crops, PMPs will be subject to additional biosafety considerations and are set to challenge the complex and overlapping regulations that currently govern GM plants, plant biologics (see Note 2) and ‘conventional’ pharmaceutical production. The areas of responsibility are being mapped out between the different regulatory agencies (Sparrow, P.A.C., Irwin, J., Dale, P., Twyman, R.M., and Ma, J.K.C. (2007) Pharma-Planta: Road testing the developing regulatory guidelines for plant-made pharmaceuticals. Transgenic Res., 2007), with specific guidelines currently being drawn up for the regulation of PMPs. In this chapter, we provide an overview of the biosafety (see Note 3), risk assessment (see Note 4) and regulation of this emerging technology. While reference will be made to EU regulations, the underlying principles of biosafety and risk assessment are generic to most countries.
Key wordsPlant-made pharmaceuticals (PMPs) Genetically modified (GM) Risk assessment Biosafety Regulation Host plant Containment Field release
- 1.Dawson, W. (2005) Herbal medicines and the EU Directive. J. Royal Coll. Phys. Edinburgh 35, 25–27.Google Scholar
- 2.ISAAA (2006) Global Status of Commercialized Biotech/GM Crops: 2006. http://www. isaaa.org/.
- 4.CPMP (2002) Points to Consider on Quality Aspects of Medicinal Products Containing Active Substances Produced by Stable Trans-gene Expression in Higher Plants (CPMP/ BWP/764/02). European Agency for the Evaluation of Medicinal Products (EMEA).Google Scholar
- 5.FDA (2002) Guidance for Industry. Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for use in Humans and Animals. Food and Drug Administration.Google Scholar
- 6.CPMP (2006) Draft Guideline on the Quality of Biological Active Substances Produced by Stable Transgene Expression in Higher Plants. European Agency for the Evaluation of Medicinal Products (EMEA).Google Scholar
- 9.Union of Concerned Scientists (2006) UCS Position Paper: Pharmaceutical and Industrial Crops. UCS. http://www.ucsusa.org/food_ and_environment/genetic_engineering/ ucs-position-paper.html
- 10.Commandeur, U., Twyman, R.M., and Fischer, R. (2003). The biosafety of molecular farming in plants. AgBiotechNet 5, 1–9.Google Scholar
- 11.Dunwell, J. (2005) Technologies for Biological Containment of GM and Non-GM Crops. DEFRA Contract CPEC 47.Google Scholar