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Nanoparticles In Drugs

Volume 408: debated on Thursday 3 July 2003

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To ask the Secretary of State for Health if his Department has made an assessment of the need to regulate the toxicity of nanoparticles used in drugs. [117006]

The Department considers that the toxicity of nanoparticles used in drugs is already adequately regulated and assessed during the marketing authorisation assessment process of the individual products. The Medicines and Healthcare products Regulatory Agency (MHRA), on behalf of the Licensing Authority, grants marketing authorisations for medicinal products, provided that satisfactory quality, safety and efficacy data have been submitted for the medicinal product for use in the proposed indication and that the risk benefit is deemed favourable. Part of the assessment process involves ensuring that the toxicity of the final drug product has been adequately investigated and tested in the clinical trials submitted in support of the application. Appropriate trials will need to be conducted with the particle size of the drug in the final product that is intended for marketing. The drug manufacturer will also have to satisfy the MHRA that it can consistently produce the product from batch to batch, including particle size.