title: European Union guidance on the quality, safety and efficacy of DNA vaccines and regulatory requirements.
abstract: A European Union note for guidance on gene transfer medicinal products is being developed by the Biotechnology Working Party (BWP) of the Committee for Proprietary Medicinal Products (CPMP) which will include guidance for DNA vaccines. The 'Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products' outlines the information required to assure the quality of the plasmid DNA intended to be used as a vaccine. It also provides guidance on preclinical safety evaluation and on clinical efficacy and safety evaluation with regard to obtaining marketing authorisation according to Council Regulation No. (EEC) 2309/93. Before initiating a clinical trial, it is necessary to obtain an appraisal from the relevant central and/or local ethics committees, and the competent authority within the member state(s) concerned has to authorise, or be notified of, the clinical trial. Harmonisation of gene therapy and DNA vaccine regulations as well as co-operation between relevant ethics committees and authorities in Europe is currently being improved.
authors.affiliation: National Institute for Biological Standards and Control, Potters Bar, Herts, UK.
authors.forename: J S
authors.initials: JS
authors.lastname: Robertson
authors.forename: K
authors.initials: K
authors.lastname: Cichutek
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000592:standards; D004992:Ethics, Medical; D005062:European Union; D015316:Genetic Therapy / Q000009:adverse effects / Q000592:standards; D005858:Germany; D006801:Humans; D008389:Marketing of Health Services; D011786:Quality Control; D012449:Safety; D019444:Vaccines, DNA / Q000009:adverse effects / Q000592:standards*
chemical_list: D019444:Vaccines, DNA