Medicines Registration in the Australia

Medicines Registration in the Australia

Details

  • Start date: 19 October 2022
  • Start time: 08:00 (Kyiv)
  • Finish date: 21 October 2022
  • Finish time: 14:00 (Kyiv)
  • Duration: 3 days per 6 hours
  • Break: yes
  • Category: Registration of medicines
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: English
  • PROGRAM

    Day 1

    • Scope
    • TGA basics – Role of TGA in regulation of medicines
    • Regulation basics - What is the legal definition of a medicinal product or therapeutic goods?
    • How therapeutic goods are regulated in Australia? TGA classifications of medicines.
    • Australian register of therapeutic goods (ARTG)
    • Scheduling basics – Scheduling of medicines and poisons.
    • Marketing Authorization Basics – Import and export requirements. Which medicinal products need authorization? Which medicinal products can be manufactured or imported and used without authorization?
    • Sponsor Requirements
    • Legal status – will be discussed under the legislative instruments on the first day and for different authorizations as applicable.
    • Therapeutic Goods Act 1989
    • Therapeutic Goods Regulations 1990
    • The poisons standard regulations
    • Marketing authorization Prescription medicines -
    • Authorization process and life cycle
    • Procedural aspects: the regulator(s), steps and timelines, dossier format, the web portal for applying, and fees.
    • Types of applications (stand-alone, abbreviated) and dossier content requirements.
    • Local requirements: local clinical trial(s), GMP certification by the target country, local pharmacopeia, etc.
    • Variations/changes to the dossier.
    • Post-approval commitments and additional requirements imposed by the regulator.
    • Scientific and procedural guidelines
    • Guidance and guideline documents: laws/regulations, scientific guidelines, procedural guidance, templates.
    • International Regulations: Which major regulatory jurisdiction's guidelines are usually followed (ICH,
    • FDA, EMA, WHO, PIC/S, ISO…)?
    • Abbreviated, simplified, or specialized requirements or procedures
    • Recognition of foreign marketing authorizations.
    • Orphan drugs, shortages, ATMPs (genes and biologicals out of scope, basic overview shall be provided),
    • pediatric medicines, radiopharmaceuticals (basic overview), herbal, and homeopathic medicines
    • (covered under complementary medicines in Australia on day 3).
    • Accelerated procedures.
    • Expanded access.
    • Supporting measures, such as scientific advice (+ fees) and regulatory support (e.g., PRIME or breakthrough therapy designations).

     

    Day 2

    • Marketing authorization Non-prescription medicines/OTC -
    • Authorization process and life cycle
    • Procedural aspects: the regulator(s), steps and timelines, dossier format, the web portal for applying, and fees.
    • Types of applications (stand-alone, abbreviated) and dossier content requirements.
    • Local requirements: local clinical trial(s), GMP certification by the target country, local pharmacopeia, etc.
    • Variations/changes to the dossier.
    • Post-approval commitments and additional requirements imposed by the regulator.
    • Scientific and procedural guidelines
    • Guidance and guideline documents: laws/regulations, scientific guidelines, procedural guidance, templates.
    • Which major regulatory jurisdiction's guidelines are usually followed (ICH, FDA, EMA, WHO, PIC/S, ISO…)?
    • Manufacturing authorization and GMP
    • How is GMP certification for a medicinal product obtained?
    • The regulator(s), steps and timelines, and fees.
    • What are GMP regulations followed?
    • GMP for active substances and excipients.
    • Which countries' GMP certificates are recognized?
    • Product information
    • Information for healthcare professionals, patients/users + user testing, package information.
    • Advertisement regulations.

     

    Day 3

    • Marketing authorization Complementary medicines -
    • Complementary medicines – Overview of the regulation and pathways
    • Listed and registered complementary medicines and dossier content
    • Variations/changes to the dossier.
    • Post-approval commitments and additional requirements imposed by the regulator.
    • Scientific and procedural guidelines
    • Guidance and guideline documents: laws/regulations, scientific guidelines, procedural guidance, templates.
    • Which major regulatory jurisdiction's guidelines are usually followed (ICH, FDA, EMA, WHO, PIC/S, ISO…)?
    • Pharmacovigilance
    • The scope of products covered by the PV regulations.
    • Basic requirements.
    • PV inspections.
    • Penalties and sanctions
    • Offense classification and penalty rules (market suspension, fines, imprisonment).