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Scientific guidelines

EU guidelines

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 and Guidelines issued by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. EU and ICH 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 EU and ICH guidelines that are adopted in Australia prior to manufacturing and supplying a medicine.

While EU and ICH Guidelines adopted in Australia are generally not mandated in Australian 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 an EU or ICH Guideline, the TGA undertakes an extensive process of internal and external consultations to ensure the Guidelines in consistent with prevailing requirements in Australia. TGA publishes a searchable list of European Union and ICG 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.

European Union and ICH Guidelines adopted in Australia

Displaying 1 - 10 of 346

Batch release guidelines

Categories: Biological medicines | Drug product | Batch release

Effective 1 June 2014: For batch release Guidelines on vaccines listed below, sponsors are referred to the European Directorate for the Quality of Medicines (EDQM) procedures and guidelines for the application of Official Control Authority Batch Release (OCABR), available from: Guidelines for EU Official Control Authority Batch Release for Human Biological Medicines. These replace the EDQM OCABR Guidelines previously adopted by TGA in October 2004 (Meningococcal C Polysaccharide Protein Conjugate Vaccine and Multivalent Pneumococcal Polysaccharide Conjugate Vaccine) or February 2003 (all other vaccine listed below).

Sponsors should note that for each of the vaccines listed below, Section 2 of the EDQM OCABR guideline (which refers to mandatory testing) is NOT adopted in Australia, however TGA reserves the discretionary right to take samples and test. Sponsors should also note in respect of Section 4 (which relates to certification that materials derived from ruminants are compliant with Directive 1999/82/EEC), that the 'Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure' is relevant to assessment in Australia.

  • Cell Cultured Influenza Vaccine (Surface Antigen, Inactivated) (added 10 November 2014)
  • BCG Vaccine
  • Cholera Vaccine (Oral, Inactivated) (added 15 September 2014)
  • Diphtheria and Tetanus Vaccine (Adsorbed)
  • Diphtheria, Tetanus and Pertussis (Acellular Component) Combined Vaccine (Adsorbed)
  • Diphtheria, Tetanus, Pertussis (Whole Cell) Combined Vaccine (Adsorbed)
  • Diphtheria, Tetanus, Pertussis (Acellular Component) with separate Haemophilus Type B Conjugate Combined Vaccine (adsorbed) (added 15 September 2014)
  • Diphtheria, Tetanus, Pertussis (Acellular Component) and Hepatitis B (rDNA) Combined Vaccine (Adsorbed)
  • Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated) and Haemophilus Type B Conjugate Combined Vaccine (Adsorbed)
  • Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated), Hepatitis B (rDNA) with separate Haemophilus Type B Conjugate, Combined Vaccine (adsorbed) (added 15 September 2014)
  • Diphtheria, Tetanus, Pertussis (Acellular Component) and Poliomyelitis (Inactivated) Combined Vaccine (Adsorbed)
  • Haemophilus Type B Conjugate and Hepatitis B (rDNA) Combined Vaccine
  • Haemophilus Type B Conjugate Vaccine
  • Haemophilus Type B Conjugate and Meningococcal C Conjugate Combined Vaccine (added 15 September 2014)
  • Hepatitis A Vaccine (Inactivated) and Hepatitis B (rDNA) Combined Vaccine (Adsorbed)
  • Hepatitis A Vaccine (Inactivated, Adsorbed)
  • Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (Adsorbed) for Mix-At-Use Format Products (added 15 September 2014)
  • Hepatitis B (rDNA) Vaccine
  • Human Papillomavirus (rDNA) Vaccine (added 15 September 2014)
  • Influenza Vaccine
  • Japanese Encephalitis Vaccine (Inactivated) (added 15 September 2014)
  • Measles, Mumps and/or Rubella Component Combined Vaccine
  • Measles Vaccine
  • Measles, Mumps, Rubella and Varicella Combined Vaccine (added 15 September 2014)
  • Meningococcal B Vaccine (Adsorbed) (added 15 September 2014)
  • Meningococcal Polysaccharide Vaccine
  • Monovalent or Multivalent Meningococcal Conjugate Vaccine, formerly under the title Meningococcal C Polysaccharide Protein Conjugate Vaccine (added 15 September 2014)
  • Multivalent Pneumococcal Polysaccharide Conjugate Vaccine
  • Pandemic Influenza Vaccine (added 15 September 2014)
  • Pertussis Vaccine (Acellular Component, Adsorbed)
  • Pneumococcal Polysaccharide Vaccine
  • Poliomyelitis Vaccine (Inactivated)
  • Poliomyelitis Vaccine (Oral) (OPV) Monovalent Bulk
  • Poliomyelitis Vaccine (Oral) (OPV)
  • Rabies Vaccine
  • Rotavirus Vaccine (added 15 September 2014)
  • Typhoid Polysaccharide Vaccine
  • Typhoid Vaccine (Live-Strain Ty21a, Oral)
  • Varicella Vaccine and Shingles Vaccine (added 15 September 2014)
  • Yellow fever vaccine
  • Live Attenuated Influenza Vaccine (added 2 February 2016)

EU/ICH effective date: 12 Feb 2002

Production and Quality Control of Medicinal Products derived by recombinant DNA Technology

Categories: Biological medicines | Drug substance | Manufacture and characterisation and control of the drug substance

EU/ICH effective date: 12 Feb 2002

Production and Quality Control of Cytokine Products Derived by Biotechnological Processes

Categories: Biological medicines | Drug substance | Manufacture and characterisation and control of the drug substance

EU/ICH effective date: 12 Feb 2002

Gene Therapy Product Quality Aspects in the Production of Vectors and Genetically Modified Somatic Cells

Categories: Biological medicines | Drug substance | Manufacture and characterisation and control of the drug substance

EU/ICH effective date: 12 Feb 2002

Radiopharmaceuticals Based on Monoclonal Antibodies

Categories: Quality | Specific types of products

EU/ICH effective date: 12 Feb 2002

Replacement of Chlorofluorocarbons (CFC) in Metered Dose Inhalation Products

Replaces: III/5378/93 (Adopted by TGA 1 January 1995)

Categories: Clinical efficacy and safety | Respiratory system | Multidisciplinary | Miscellaneous

EU/ICH effective date: 12 Feb 2002

Medicinal Products (Non-Steroidal Anti-Inflammatory Compounds) for the Treatment of Chronic Disorders

Categories: Clinical efficacy and safety | Rheumatology / musculoskeletal system

EU/ICH effective date: 12 Feb 2002

Clinical Investigation of Corticosteroids Intended for Use on the Skin

Categories: Clinical efficacy and safety | Dermatologicals

EU/ICH effective date: 12 Feb 2002

Investigation of Chiral Active Substances

Replaces: III/3501/91 (Adopted by TGA 1 January 1995)

Categories: Quality | Active substance | Clinical efficacy and safety | General (clinical) | Multidisciplinary | Miscellaneous | General (nonclinical)

EU/ICH effective date: 12 Feb 2002

Pharmacokinetic Studies in Man

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

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