BioWorld International Correspondent

BRUSSELS, Belgium - The European Medicines Agency has set itself a challenging biotechnology agenda for this year.

The just-released 2005 plan of its biotechnology working party lists more than 60 initiatives across the range of biotechnology-related regulation, in addition to the working party's routine tasks of providing advice on applications for marketing authorizations and on post-marketing data evaluation.

Gene therapy and cell therapy are to see new regulations, with guidance on quality, preclinical and clinical aspects of gene transfer medicines using lentiviral vectors and on assays for neutralizing antibodies. Also there are to be guidelines for preparation of a common assay methodology for interferons and neutralizing antibodies in multiple sclerosis, and updated advice on xenogeneic cell therapy products. The manufacture and quality control of human somatic cell therapy medicines will be updated.

The agency will issue new guidance on potency testing for cell-based immunotherapy medicines, on production and control of biotechnological and biological medicines, on the quality aspects of similar products in which the active substances are biotechnology-derived proteins, on clinical investigation of the pharmacokinetics of therapeutic proteins, and on labeling of insulin analogues

For vaccines, it will issue new rules on stability data for storage periods and on adjuvants in vaccines for human use. It will update guidance on the reduction, elimination or substitution of thiomersal in vaccines, on harmonization of requirements for influenza vaccines, and on the development of live attenuated influenza vaccines. It also will provide input for treatment and prophylaxis of biological agents that might be used as weapons of bioterrorism.

In addition, it is revising the European Union guidance on minimizing the risks of TSE transmission via medicines, on plasma-derived medicines (including testing for viral markers), on production and quality control of monoclonal antibodies, and the use of transgenic animals in the manufacture of biological medicines.

Tighter Rules On Environmental Information

Release of genetically modified organisms into the environment became even more closely monitored as of Feb. 14, when new European Union rules came into effect across member states giving the public increased access to environmental information. The new rules grant a right of access to environmental information and extend the scope of access to data on emissions into the environment, their impact on public health and the results of environmental impact assessments. They also ensure that environmental information is made available and disseminated to the public. The new legislation brings the EU in line with the environmental information requirements of the 1998 Aarhus Convention, a UN-sponsored agreement to widen public access to information on the environment.

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