Document ID: chunk:federal_register_of_legislation:F2006L02853:body:0:p2
Version: federal_register_of_legislation:F2006L02853
Segment Type: other
Provision Reference: 
Character Range: 2816–6401

Program.
       Minister means the Minister for Industry, Tourism and Resources.
       pharmaceuticals industry means companies that participate in the discovery, creation and supply of pharmaceuticals that are, or are intended to be, regulated under the Therapeutic Goods Act 1989 as registered drugs or under equivalent provisions in comparable countries (such as, in the United States, through the Food and Drug Administration, and in Europe, through the European Medicines Agency

       pharmaceutical means a chemical or biological substance containing one or more active ingredients used, or intended for use, in the treatment or prevention of disease in humans.  For the purposes of this program, a pharmaceutical is a drug registered or intended to be registered under the Therapeutic Goods Act 1989 or under equivalent provisions in comparable countries (such as, in the United States, through the Food and Drug Administration, and in Europe, through the European Agency for the Evaluation of Medicinal Products).  For the purposes of this program, vaccines and blood products for human use are pharmaceuticals.

       pharmaceutical research and development (R&D) activities means:
          1. Systematic, investigative and experimental activities:
                (a)     that involve innovation or technical risk;
                (b)     the object of which is new knowledge, or new or improved materials, products, processes, services, or devices for the delivery of pharmaceuticals; and
                (c)     which have a direct link to, or are of direct relevance to, the development of a pharmaceutical or a device for the delivery of a pharmaceutical.

           2. Activities that directly contribute to systematic, investigative and  experimental activities of the kind described above.

         Subject to the application of the definition of pharmaceutical research and development (R&D) activities, the following broad types of activity may be eligible:
                (a)   basic pharmaceutical research;
                (b)   drug discovery, including biological screening;
                (c)   the synthesis and/or extraction of therapeutic substances;
                (d)   drug formulation;
                (e)   bioequivalence studies
                (f)    stability testing on a pharmaceutical;
                (g)   pre-clinical (including animal toxicology) work and phase I, II and III trials;
                (h)   clinical trials of a registered drug in a new indication, formulation, route of administration or dosage;
                (i)     pharmaceutical development activities relating to the building and testing of prototypes;
                (j)     laboratory evaluation to determine likely commercial production processes;
                (k)   scale-up from laboratory to pilot plant;
                (l)     significant process improvements;
                (m) obtaining industrial rights, including patents (but note expenditure limits);
                (n)   computer software activities integral to the R&D; and
                (o)   supporting activities that are directly related to the carrying on of the R&D activities referred to above, including pharmaceutical services such as protocol development; the development, preparation and supply of active ingredients for use in non-clinical testing and clinical trials; clinical trial management; bioinformatics; and biostatistical analysis, activities associated with complying with statutory requirements or standards needed for drug or device registration.

         The