Biotechnology/biological guidelines
European Union guidelines adopted in Australia
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AGRD refers to: Australian Guidelines for the Registration of Drugs, Volume I, second edition, July 1994 (Australian Government Publishing Service). Superseded by the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
ARGPM refers to: Australian Regulatory Guidelines for Prescription Medicines, June 2004. Published on the Therapeutic Goods Administration (TGA) Internet site
Rules 2001 (Vol. 9) refers to: EU Pharmacovigilance Rules for Human and Veterinary Medicinal Products - EudraLex Volume 9 - December 2001
Rules 1989 refers to: The Rules Governing Medicinal Products in the European Community Volume III 1989 - Guidelines on the quality safety and efficacy of medicinal products for human use
Rules Addendum refers to: The Rules Governing Medicinal Products in the European Community Volume III Addendum July 1990 - Guidelines on the quality safety and efficacy of medicinal products for human use
Rules 1998 (3A) refers to: The Rules Governing Medicinal Products in the European Union - EudraLex - Medicinal products for human use, 1998 Edition: Volume 3A - Quality and Biotechnology
Rules 1998 (3B) refers to: The Rules Governing Medicinal Products in the European Union - EudraLex - Medicinal products for human use, 1998 Edition: Volume 3B - Safety and the Environment
Rules 1998 (3C) refers to: The Rules Governing Medicinal Products in the European Union - EudraLex - Medicinal products for human use, 1998 Edition: Volume 3C - Efficacy and information on the medicinal product
Rules 1997 (4) refers to: The Rules Governing Medicinal Products in the European Union - EudraLex - Medicinal products for human and veterinary use, 1997 Edition: Volume 4 - Pharmaceutical Legislation - Good Manufacturing Practices
General guidelines
pp. 205 - 216 of Rules 1998 (3A) - 3AB1a (pdf,63kb)
Production and Quality Control of Medicinal Products Derived by Recombinant DNA Technology
Replaces: III/3477/92 Revision 1994 (Adopted by TGA April 1996) and pp. 39 - 52 of Rules 1989
Effective: 12 February 2002
pp. 223 - 235 of Rules 1998 (3A) - 3AB3a (pdf,64kb)
Production and Quality Control of Cytokine Products Derived by Biotechnological Processes
Replaces: pp. 23 - 40 of Rules Addendum
Effective: 12 February 2002
pp. 237 - 261 of Rules 1998 (3A) - 3AB4a (pdf,112kb)
Production and Quality Control of Monoclonal Antibodies
Replaces: III/5271/94 (Adopted by TGA April 1996) and pp. 41 - 55 of Rules Addendum
Effective: 12 February 2002
pp. 275 - 286 of Rules 1998 (3A) - 3AB6a (pdf,61kb)
Gene Therapy Product Quality Aspects in the Production of Vectors and Genetically Modified Somatic Cells
Replaces: III/5863/93 (Adopted by TGA April 1996)
Effective: 12 February 2002
pp. 287 - 294 of Rules 1998 (3A) - 3AB7a (pdf,42kb)
Use of Transgenic Animals in the Manufacture of Biological Medicinal Products for Human Use
Replaces: III/3612/93 (Adopted by TGA April 1996)
Effective: 12 February 2002
CPMP/BWP/1143/00 (pdf,57kb)
Position Statement on the Use of Tumourigenic Cells of Human Origin for the Production of Biological and Biotechnological Medicinal products
Published: TGA Internet site
Effective: 10 January 2002
CPMP/BWP/3088/99 (pdf,128kb)
Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products
Published: TGA Internet Site
Effective: 7 May 2003
Adopted by the TGA with the following notation:
Sponsors are advised that consultation with the Office of the Gene Technology Regulator (OGTR) is required for applications covered by this guideline, as is described in Section 30C of the Therapeutic Goods Act.
EMEA/CPMP/BWP/3207/00, rev 1 (pdf,196kb)
Guideline on Comparability of Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues
Published: TGA Internet site
Effective: 2 May 2005
Active substance & medicinal products guidelines
pp. 217 - 222 of Rules 1998 (3A) - 3AB2a (pdf,32kb)
Quality of Biotechnological Products: Analysis of the Expression Construct in Cell Lines used for Production of rDNA Derived Protein Products
Replaces: CPMP/ICH/139/95 (Adopted by TGA 1 May 2000)
Effective: 12 February 2002
pp. 263 - 273 of Rules 1998 (3A) - 3AB5a (pdf,58kb)
Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
Replaces: CPMP/ICH/138/95 (Adopted by TGA 1 May 2000)
Effective: 12 February 2002
pp. 355 - 372 of Rules 1998 (3A) - 3AB14a (pdf,61kb)
Harmonisation of Requirements for Influenza Vaccines
Replaces: III/3188/91 (Adopted by TGA July 1994)
Effective: 12 February 2002
pp. 373 - 380 of Rules 1998 (3A) - 3AB15a (pdf,41kb)
Allergen Products
Replaces: III/9271/90 (Adopted by TGA August 1997) and is the same as CPMP/BWP/243/96
Effective: 12 February 2002
CHMP/437/04 (pdf,109kb)
Guideline on Similar Biological Medicinal Products
Published: TGA Internet site
Effective: 15 June 2006
CPMP/BWP/328/99 (pdf,36kb)
Development Pharmaceutics for Biotechnological and Biological Products (Annex to Note for Guidance on Development Pharmaceutics)
Published: TGA Internet site
Effective: 19 April 2001
CPMP/BWP/477/97 (pdf,75kb)
Note for Guidance on Pharmaceutical & Biological Aspects of Combined Vaccines
Published: TGA Internet Site
Effective: 13 February 2001
CPMP/BWP/2490/00 (pdf,178kb)
Cell Culture Inactivated Influenza Vaccines - Annex to Note for Guidance on Harmonisation of Requirements for Influenza Vaccines CPMP/BWP/214/96
Published: TGA Internet Site
Effective: 5 March 2003
CPMP/ICH/294/95 (pdf,110kb)
Note for Guidance on Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products
Published: TGA News September 1999
Effective: 1 October 1999
CPMP/ICH/365/96 (pdf,92kb)
Note for Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Published: TGA News April 2000
Effective: 1 May 2000
EMEA/CPMP/BWP/3734/03 (pdf,154kb)
Guideline on the Scientific Data Requirements for a Vaccine Antigen Master File (VAMF)
Published: TGA Internet Site
Effective: 24 August 2004
Batch release guidelines
EDQM OCABR # 02 - 2001 (pdf,28kb)
Clotting Factor Concentrates, Plasma Inhibitor Concentrates and Fibrin Sealants
Published: TGA Internet Site
Effective: 6 November 2002
EDQM OCABR # 03 - 2001 (pdf,21kb)
Human Albumin
Published: TGA Internet Site
Effective: 6 November 2002
EDQM OCABR # 04 - 2001 (pdf,24kb)
Human Immunoglobulin
Published: TGA Internet Site
Effective: 6 November 2002
EDQM OCABR # 06 - 2001 (pdf,22kb)
Validation of Nucleic Acid Amplification Technology (NAT) for the Detection of Hepatitis C Virus (HCV) RNA in Plasma Pools
Published: TGA Internet Site
Effective: 6 November 2002
EDQM OCABR # 07 - 2001 (pdf,23kb)
BCG Vaccine
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 08 - 2001 (pdf,21kb)
Diphtheria and Tetanus Vaccine (Adsorbed)
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 10 - 2001 (pdf,28kb)
Diphtheria, Tetanus and Pertussis (Acellular Component) Combined Vaccine (Adsorbed)
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 11 - 2001 (pdf,28kb)
Diphtheria, Tetanus, Pertussis (Whole Cell) Combined Vaccine (Adsorbed)
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 13 - 2001 (pdf,35kb)
Diphtheria, Tetanus, Pertussis (Acellular Component) and Haemophilus Type B Conjugate
Combined Vaccine (Adsorbed)
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 14 - 2001 (pdf,31kb)
Diphtheria, Tetanus, Pertussis (Acellular Component) and Hepatitis B (rDNA) Combined Vaccine (Adsorbed)
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 15 - 2001 (pdf,40kb)
Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated) and Haemophilus Type B Conjugate Combined Vaccine (Adsorbed)
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 16 - 2001 (pdf,32kb)
Diphtheria, Tetanus, Pertussis (Acellular Component) and Poliomyelitis (Inactivated) Combined Vaccine (Adsorbed)
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 19 - 2001 (pdf,28kb)
Haemophilus Type B Conjugate and Hepatitis B (rDNA) Combined Vaccine
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 20 - 2001 (pdf,29kb)
Haemophilus Type B Conjugate Vaccine
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 21 - 2001 (pdf,26kb)
Hepatitis A Vaccine (Inactivated) and Hepatitis B (rDNA) Combined Vaccine (Adsorbed)
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 22 - 2001 (pdf,29kb)
Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (Adsorbed)
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 23 - 2001 (pdf,36kb)
Hepatitis A Vaccine (Inactivated, Adsorbed)
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 24 - 2001 (pdf,28kb)
Hepatitis A (Virosomal) Vaccine
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 25 - 2001 (pdf,37kb)
Hepatitis B (rDNA) Vaccine
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 26 - 2001 (pdf,25kb)
Influenza Vaccine
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 27 - 2001 (pdf,53kb)
Measles, Mumps and/or Rubella Component Combined Vaccine
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 28 - 2001 (pdf,32kb)
Measles Vaccine
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 29 - 2001 (pdf,22kb)
Meningococcal Polysaccharide Vaccine
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 31 - 2001 (pdf,29kb)
Pertussis Vaccine (Acellular Component, Adsorbed)
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 32 - 2001 (pdf,21kb)
Pneumococcal Polysaccharide Vaccine
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 33 - 2001 (pdf,36kb)
Poliomyelitis Vaccine (Inactivated)
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 34 - 2001 (pdf,27kb)
Rabies Vaccine
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 35 - 2001 (pdf,29kb)
Rubella Vaccine
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 37 - 2001 (pdf,21kb)
Typhoid Polysaccharide Vaccine
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 38 - 2001 (pdf,27kb)
Typhoid Vaccine (Live-Strain Ty21a, Oral)
Published: TGA Internet Site
Effective: 7 February 2003
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 40 - 2002 (pdf,40kb)
Meningococcal C Polysaccharide Protein Conjugate Vaccine
Published: TGA Internet site
Effective: 29 October 2004
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
EDQM OCABR # 41 - 2002 (pdf,32kb)
Multivalent Pneumococcal Polysaccharide Conjugate Vaccine
Published: TGA Internet site
Effective: 29 October 2004
Adopted by the TGA with the following notation:
"Sponsors should note that Section 2 of this guideline (which refers to mandatory testing) is NOT adopted, 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 'TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines' is relevant to assessment in Australia."
III/3084/93
Control Authority Batch Release of Yellow Fever Vaccine
Published: AGRD
Effective: 1 January 1995
III/3775/92
Control Authority Batch Release of: Absorbed Diphtheria, Tetanus, Pertussis and Combined Vaccines; Poliomyelitis Vaccine (Oral); Monovalent Bulk Live Oral Polio Vaccine; Measles Vaccine; Influenza Vaccine;
Published: AGRD, with effect 1 January 1995
Notation added 7 February 2003:
"Sponsors should note that only the portion of this guideline relating to Live Oral Polio Vaccine remains adopted by the TGA. All other vaccine batch release procedures covered in this document have been replaced by the vaccine specific EDQM guidelines released in 2001."
Blood/plasma guidelines
III/5272/94
Contribution to Part II of the Structure of the Dossier for Applications for Marketing Authorisation - Control of Starting Materials for the Production of Blood Derivatives
Published: TGA News April 1996
Effective: April 1996
pp. 351 - 353 of Rules 1998 (3A) - 3AB13a (pdf,12kb)
Plasma Pool Testing
Replaces: III/5193/94 (Adopted by TGA 15 December 2000)
Effective: 12 February 2002
See also: CPMP/BWP/269/95 Rev 3 (Adopted by TGA 30 August 2001)
CPMP/BPWG/1089/00 (pdf,61kb)
Guideline on the clinical investigation of Plasma derived Fibrin Sealant/Haemostatic Products
Published: TGA Internet Site
Effective: 13 January 2005
CPMP/BWP/269/95 Rev 3 (pdf,271kb)
Note for Guidance on Plasma-Derived Medicinal Products
Published: TGA Internet site
Effective: 30 August 2001
See also: pp. 351 - 353 of Rules 1998 (3A) - 3AB13a (Plasma Pool Testing - Adopted by TGA, effective: 12 February 2002)
CPMP/BWP/390/97 (pdf,33kb)
The Introduction of Nucleic Acid Amplification Technology (NAT) for the Detection of Hepatitis C Virus RNA in Plasma Pools Addendum to Note for Guidance on Plasma derived Medicinal Products (CPMP/BWP/269/95)
Published: TGA Internet site
Effective: 23 February 2001
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EMEA/CPMP/BWP/3794/03 (pdf,659kb)
Guideline on the Scientific Data Requirements for a Plasma Master File (PMF)
Published: TGA Internet site
Effective: 18 February 2005
EMEA/CHMP/BWP/298388/05 (pdf,46kb)
Guideline on Validation of Immunoassay for the Detection of Antibody to Human Immunodeficiency Virus (Anti-HIV) in Plasma Pools
Published: TGA Internet site
Effective: 5 February 2008
EMEA/CHMP/BWP/298390/2005 (pdf,53kb)
Guideline on Validation of Immunoassay for the Detection of Hepatitis B Virus Surface Antigen (HBSAG) in Plasma Pools
Published: TGA Internet site
Effective: 5 February 2008
Comparability/similar biological medicinal products
CHMP/437/04 (pdf,109kb)
Guideline on Similar Biological Medicinal Products
Published: TGA Internet site
Effective: 15 June 2006
EMEA/CHMP/BWP/49348/2005 (pdf,118kb)
Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Quality Issues
Published: TGA Internet site
Effective: December 2006
EMEA/CPMP/BWP/3207/00, rev 1 (pdf,196kb)
Guideline on Comparability of Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues
Published: TGA Internet site
Effective: 2 May 2005
Viral safety/TSE guidelines
pp. 295 - 309 of Rules 1998 (3A) - 3AB8a (pdf,78kb)
Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses
Replaces: III/8115/89 (Adopted by TGA July 1994) and CPMP/BWP/268/95 (Adopted by TGA August 1997)
Effective: 12 February 2002
pp. 311 - 313 of Rules 1998 (3A) - 3AB9a (pdf,13kb)
Validation of Virus Removal/Inactivation Procedures: Choice of Viruses
Replaces: III/5543/94 (Adopted by TGA 15 December 2000)
Effective: 12 February 2002
CPMP/BWP/CPMP/5136/03 (pdf,223kb)
Guideline on the investigation of manufacturing processes for plasma-derived medicinal products with regard to VCJD risk
Published: TGA Internet site
Effective: 12 May 2005
CPMP/BWP/5180/03 (pdf,173kb)
Guideline on assessing the risk for virus transmission - new chapter 6 of the note for guidance on plasma - derived medicinal products (CPMP/BWP/269/95)
Published: TGA Internet site
Effective: 20 May 2005
CPMP/ICH/295/95 (pdf,211kb)
Note for Guidance on Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Published: TGA News April 2000
Effective: 1 May 2000
EMEA/410/01 Rev 2 (pdf,242kb)
Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products
Published: TGA Internet site
Replaces: EMEA 410/01 Rev 1 (Adopted by TGA 20 December 2002)
Effective: 20 September 2005
Adopted by the TGA with the following notations:
"This EU Guideline replaces EMEA/410/01 Rev 1 (adopted by the TGA 20 December 2002)."
"This EU Guideline should be interpreted in the context of the TGA Policy Document - Supplementary Requirements for Therapeutic Goods for Minimising the Risk of Transmitting Transmissible Spongiform Encephalopathies (TSE's)."
The European Agency for the Evaluation of Medicinal Products (EMEA)