Australia’s regulatory body for therapeutic goods, the Therapeutic Goods Administration (“TGA”), has initiated public consultations on the adoption of European Union guidelines in Australia relating to various clinical matters.

Of note is the TGA’s intention to adopt the European Medicines Agency (“EMA”) Guideline on similar biological medicinal products containing monoclonal antibodies. This Guideline sets out the non-clinical and clinical requirements for medicinal products containing monoclonal antibodies (“mAb”) that are similar to authorised medicinal products (i.e. “mAb biosimilars”). Aspects relating to pharmaco-toxicological, pharmacokinetic, pharmacodynamic, efficacy and safety requirements are addressed, as well as aspects relating to pharmacovigilance.

Also of note is the TGA’s proposal to adopt the Guideline on Quality of biological active substances produced by transgene expression in animals. This Guideline regulates the use of transgenic animals for the manufacture of recombinant therapeutic proteins. Quality issues affecting active substances produced by the expression of one or more transgenes stably located in the nuclear genomes of animals are addressed. Such issues include the selection, generation and control of the production animals and evaluation of freedom from adventitious agents. The standards of proteins produced by transgenic animals, and their quality attributes, are aligned with the standards of proteins produced in mammalian cells in a fermentation system. The Guidelines include references to currently accepted guidance on standards of downstream processing systems and regulatory compliance of active substances of biotherapeutic medicinal products. However, production using transiently transfected animals or cloned animals, unless the latter method was used for the generation of a founder transgenic animal, is considered to fall outside the scope of these Guidelines.

Other EMA Guidelines that are proposed to be adopted by the TGA include:

  • Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections;
  • Guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease;
  • Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus;
  • ICH guideline E3 - questions and answers (R1) - Step 5;
  • Guideline on the evaluation of anticancer medicinal products in man;
  • Answers from the CHMP Scientific Advisory Group (SAG) for Oncology for Revision of the anticancer guideline;
  • Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man methodological consideration for using progression-free survival (PFS) or disease-free survival (DFS) in confirmatory trials;
  • Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man Condition Specific Guidance;
  • Guideline on the quality of biological active substances produced by stable transgene expression in higher plants;
  • Guideline on the clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder (ADHD);
  • Guideline on good pharmacovigilance practices: Module V - Risk management systems; and
  • Guideline on Dossier Structure and Content for Pandemic Influenza Vaccine Marketing Authorisation Application (Revision).

The deadline for submission of any comments on the proposed adoption or non-adoption of the EMA guidelines is 28 March 2014. Comments may be submitted by email to euguidelines@tga.gov.au.