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International scientific guidelines adopted in Australia

5 August 2020

The TGA closely aligns its regulatory approaches to therapeutic products with those of comparable international regulatory counterparts wherever possible.

Technical data requirements for applications to register or vary the registration of medicines in Australia are closely aligned with requirements set out in relevant:

  • European Union (EU) Guidelines
  • Guidelines issued by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • Food and Drug Administration (USA)

International Guidelines are not limited to prescription medicines, but may also apply to OTC, complementary and some listed medicines. It is important that you review the relevant guidelines that are adopted in Australia prior to manufacturing and supplying a medicine.

While guidelines that are adopted in Australia are generally not mandated by legislation, they provide guidance to sponsors to assist them to meet the legislative requirements and any deviation from a Guideline relevant to an application to register or vary the registration of a medicine must be justified.

Prior to adopting any Guideline, the TGA undertakes an extensive process of internal and external consultations to ensure the Guideline is consistent with prevailing requirements in Australia. TGA publishes a searchable list of International Guidelines adopted in Australia. Please check for current consultations on proposed guidelines for adoption in Australia.

Please note: Where EU Guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.

International scientific guidelines adopted in Australia

Displaying 31 - 40 of 373

TGA adopted date: 15 Jul 2019

Overseas effective date: 15 Jul 2019

Lapatinib film-coated tablet 250mg product specific bioequivalnce guidance

Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics | Product-specific bioequivalence

TGA adopted date: 15 Jul 2019

Overseas effective date: 17 Oct 2018

Reflection paper on the use of extrapolation in the development of medicines for paediatrics

Categories: Clinical efficacy and safety | General (clinical)

TGA adopted date: 15 Jul 2019

Overseas effective date: 1 Aug 2019

Octreotide acetate depot powder and solvent for suspension for injection 10mg, 20mg or 30mg product - specific bioequivalence guidance

Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics | Product-specific bioequivalence

TGA adopted date: 26 Mar 2002

Points to consider on the calculation and reporting of the prevalence of a condition for orphan designation

Categories: Clinical efficacy and safety | General (clinical)

p>The TGA has published guidance on eligibility criteria and supporting documentation for orphan drug designation in accordance with Part 3B of the Therapeutic Goods Regulations 1990.

Overseas effective date: 28 Sep 2011

Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products

Categories: Quality

Overseas effective date: 31 Mar 2011

Quality of herbal medicinal products/traditional herbal medicinal products

Categories: Quality

Overseas effective date: 1 Jul 2008

ICH M2 Electronic common technical document (eCTD)

Categories: Multidisciplinary

Overseas effective date: 12 Dec 2017

Guideline on Influenza Vaccines - Non-clinical and Clinical Module

Categories: Biological medicines | Drug substance | Vaccines (drug substance)

Proposed TGA annotations

  1. Concerning 5.1.1. Requirements for authorisation.

    Proposed annotation: For registration of a new seasonal influenza vaccine in Australia the TGA would generally require that the new vaccine demonstrates vaccine efficacy in a placebo-controlled trial, or non-inferior immunogenicity in comparative clinical studies against an influenza vaccine registered in Australia. If the studies for the new influenza vaccine are not prophylactic efficacy versus placebo or non-inferior immunogenicity against a registered influenza vaccine, it is likely that TGA will require the immunogenicity of the new vaccine versus a concurrent unvaccinated group to fulfil the criteria specified in the current relevant US FDA Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines (15 September 2014 or more recent update.)

  2. Concerning 7.2 Post-authorisation pharmacovigilance requirements for seasonal influenza vaccines. This section refers to the addendum document Guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU (EMA/PRAC/222346/2014).

    The TGA has adopted the EMA Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU (EMA/PRAC/222346/2014) with the exception of section 3. Data reporting and submission requirements for vaccines for which sponsors are conducting enhanced safety surveillance will be determined on a case-by-case basis.

    All applications in Australia to register new seasonal influenza vaccines must include a risk management plan, which should include a plan for enhanced safety surveillance as described in Section 2 of the Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU (EMA/PRAC/222346/2014).

    The need for different enhanced surveillance options will be evaluated on a case-by-case basis by the TGA. However, if a seasonal influenza vaccine is included in a suitable national safety surveillance program in Australia (e.g. AusVaxSafety), there would usually be no requirement for a sponsor to also conduct enhanced safety surveillance.

    If relevant product-specific Northern Hemisphere safety data are available and do not reveal any identified safety signals following confirmed use of the product, the sponsor may justify the relevance and validity of the Northern Hemisphere experience with the product and propose not to undertake enhanced safety surveillance.

    Before each Southern Hemisphere influenza immunisation season, sponsors should ensure that the pharmacovigilance plans for their seasonal influenza vaccines remain adequate to rapidly detect any increase in the frequency and/or severity of expected reactogenicity (local, systemic or allergic reactions). Effective monitoring is especially important when a seasonal strain change introduces a strain in the Southern Hemisphere prior to use in the Northern Hemisphere.

    In determining the need to alter the pharmacovigilance plan of the risk management plan, the sponsor should consider:

    • whether there has been any change to the vaccine's indications or the population in which it will be used (for example, a change in the approved age range),
    • whether there will be a strain change or other change to the vaccine that could result in a change in reactogenicity, and
    • if the vaccine will be included in national safety surveillance programs in Australia.

    If there has been a strain change for a vaccine that will not be included in a national safety surveillance program in Australia and the sponsor proposes not to perform enhanced safety surveillance because of the availability of relevant product-specific safety data from the Northern Hemisphere, then this strategy should be discussed with the TGA as soon as the safety data from the Northern Hemisphere are available.

    If a change to the pharmacovigilance plan is required, the sponsor should submit an updated risk management plan to the TGA with the application for seasonal strain variation.

    If the pharmacovigilance plan remains adequate for the new influenza season, and there are no other significant changes to the risk management plan, then there is no requirement to submit an annual risk management plan update to the TGA.

    Sponsors are reminded of their obligations for reporting significant safety issues in accordance with the Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines. Significant safety issues arising from safety data available from prior use of the vaccine and/or enhanced surveillance activities in the Northern Hemisphere should be promptly reported to the TGA.

    A sponsor should give support to the conduct of Southern Hemisphere effectiveness studies, such as case test-negative studies, especially when a seasonal strain change introduces a strain in the Southern Hemisphere prior to use in the Northern Hemisphere.

  3. Concerning 7.4 Post-authorisation pharmacovigilance requirements for Pandemic influenza vaccines.

    The second dot-point is amended by the inclusion of an introductory sentence:

    • If the pandemic influenza virus is of a HN subtype for which nonclinical and clinical data have not been included in the Core Pandemic Dossier, it is highly desirable that nonclinical and clinical data obtained from studies with the pandemic HN subtype be included in the pandemic variation dossier.

Overseas effective date: 23 Oct 2008

Guideline on Influenza Vaccines Prepared from Viruses with the Potential to cause a Pandemic and Intended for Use Outside of the Core Dossier Context

Categories: Biological medicines | Drug substance | Vaccines (drug substance) | Multidisciplinary | Vaccines (multidisciplinary)

Effective 1 November 2014: the Quality aspects of this Guideline are replaced by EMA/CHMP/BWP/310834/2012 Guideline on Influenza Vaccines - Quality Module.

The nonclinical and clinical aspects of this Guidelines continue to apply.

Overseas effective date: 6 Jan 2009

Guideline on Clinical Evaluation of New Vaccines

Replaces: CPMP/EWP/463/97 Note for Guidance on Clinical Evaluation of New Vaccines (Adopted by TGA 6 February 2002)

Categories: Multidisciplinary | Vaccines (multidisciplinary)

Sponsors in Australia should provide data on the consistency of full scale manufacturing lots in respect of clinical safety and efficacy (immunogenicity) or justify the absence of such data

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