Overview

Australia is among the emerging markets for Pharmaceutical products. For distribution or marketing of medicinal products or drugs, manufacturers must obtain approval from the Therapeutic Goods Administration (TGA), Australia – the body regulates the drug registrations and approvals in the region. The TGA has unique Regulatory requirements for the registration and life cycle management of medicinal products. With recent mandates pertaining to labeling and submission formats, it is required for manufacturers or sponsors to keep abreast with the TGA Regulatory regime.

Freyr’s experts evaluate submission data accuracy against TGA regulations to ensure compliance in all stages and thus enable accurate submission for quick health authority reviews and approvals. We support medicinal product Regulatory submissions which includes assistance in registration via different pathways (150 WD and 220 WD) based on product type. Freyr also provides post-approval support for license renewals, dossier updates and life cycle management.

 

Freyr Expertise

  • Registration of prescription medicine under the provisional approval pathway, priority review pathway (150 WD) or the standard prescription medicines registration pathway (220 WD)
  • Assistance in new/renewed/updated TGA manufacturing licenses (for Australian manufacturing sites) and Good Manufacturing Practice (GMP) clearances issued for those sites (overseas) identified in the application
  • Evaluation of the product source data from R&D and manufacturing site (executed data)
  • Regulatory consultation during the development of the medicinal products
  • Regulatory strategic support with submission procedures/ roadmaps
  • Designing of specifications for Active Pharmaceutical Ingredient (API), finished product & intermediates
  • Consulting on limits for impurities (including Genotoxic & Elemental)
  • Designing of protocols (Stability, Analytical Method Validation, Exhibit Batch, Process Validation)
  • Pre-submission administrative activities (filing pre-submission planning forms), pre-submission interactions with HA
  • Act as QPPVA (Qualified Person responsible for Pharmacovigilance in Australia) and as a local contact person to interact with HA
  • Compilation and submission of the dossiers to HA in CTD/eCTD format
  • Extension of EU dossier to Australia – conducting gap analysis, remediation plan, providing Regulatory roadmap for registration, compilation and submissions of dossiers
  • Category 1 and 2 applications (New applications and variation to ARTG entry with consequential PI change (streamlined submission process) that require evaluation of nonclinical, clinical or bioequivalence data)
  • Assisting with Regulatory strategy and compilation for self-assessable requests (data submitted upon TGA request) and category 3 applications (variations that require evaluation of only quality related data) to maintain life cycle
  • Change control evaluation and compliance activities
  • Support during TGA queries with strategy, preparation and submission of response document