       Document 0016
 DOCN  M9640016
 TI    Obtaining marketing authorization for nucleic acid vaccines in the
       European Union.
 DT    9604
 AU    Cichutek K; Department of Medical Biotechnology,
       Paul-Ehrlich-Institute,; Langen, Germany.
 SO    Ann N Y Acad Sci. 1995 Nov 27;772:178-85. Unique Identifier : AIDSLINE
       MED/96135358
 AB    Nucleic acid vaccines are promising candidates for easy-to-handle and
       cost-effective vaccines that combine the safety of subunit vaccines with
       the efficacy of live virus vaccines. In order to obtain marketing
       authorization for a nucleic acid vaccine in all member states of the
       European Union, a single application dossier has to be filed with the
       European Agency for the Evaluation of Medicinal Products. Notes for
       Guidance on the data necessary to support applications are available.
       The preclinical development of nucleic acid vaccines has to follow
       procedures of contained use according to the relevant EC directives
       which were translated into the German Gene Law. Clinical trials in
       Germany would follow the known procedures defined in the German Drug
       Law, whereas the Gene Law is not applicable. Clinical trials should be
       started only after having obtained consent of the Commission for Gene
       Therapy Trials formed under the auspices of the Federal Chamber of
       Physicians. Experience in intramuscular nucleic acid inoculation of
       animals has been gained using expression constructs comprising single
       and multiple genes of simian immunodeficiency virus. Specific antibodies
       were induced against multiple antigens. No adverse effects of nucleic
       acid inoculations were found, but more rigorous testing of specific
       safety problems will have to be performed.
 DE    Animal  AIDS Vaccines  Cercocebus atys  Clinical Trials/STANDARDS
       Containment of Biohazards  *DNA, Recombinant/ADMINISTRATION &
       DOSAGE/ADVERSE EFFECTS  Europe  *European Economic Community  Germany
       Injections, Intramuscular  Macaca mulatta  Mice  Mice, Inbred BALB C
       Safety  SIV/IMMUNOLOGY  Vaccination/*LEGISLATION & JURISPRUD  *Vaccines,
       Synthetic/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS  JOURNAL ARTICLE
       REVIEW  REVIEW, TUTORIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

