Consultations on adoption of European Union guidelines in Australia

15 November 2016

The EU guidelines below have been recommended for adoption or non-adoption by the TGA. These guidelines are open for comment on whether or not they should be adopted in Australia.

Submission of comments

Your comments on the proposed adoption or non-adoption of these EU guidelines, particularly your advice on whether you support the proposed action, would be appreciated.

Comments may be sent by email or mail and should include your full contact details.

The email address for comments is:

The postal address for comments is:

EU/ICH Guidelines Coordinator
Medicines Authorisation Branch
Therapeutic Goods Administration
PO Box 100

Guidelines proposed for adoption

This consultation closes on 5 January 2017.

How to access a pdf document

Clinical efficacy and safety guidelines

Clinical pharmacology and pharmacokinetics

EMA/CHMP/594085/2015 (pdf,199kb)
Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products
To become effective: 1 February 2017
To replace: CPMP/EWP/2655/99 Points to Consider on Pharmacokinetics and Pharmacodynamics in the Development of Antibacterial Medicinal Products

Cardiovascular system


EMA/CHMP/29947/2013/Rev. 4 (pdf,212kb)
Guideline on clinical investigation of medicinal products in the treatment of hypertension
To become effective: 1 January 2017
To replace: EMA/238/1995/Rev. 3 Guideline on clinical investigation of medicinal products in the treatment of hypertension

EMA/CHMP/50549/2015 (pdf,114kb)
Reflection paper on assessment of cardiovascular safety profile of medicinal products
To be published for information

Lipid disorders

EMA/CHMP/748108/2013, Rev. 3 (pdf,204kb)
Guideline on clinical investigation of medicinal products in the treatment of lipid disorders
To become effective: 1 January 2017
To replace: EMA/CHMP/748108/2013 Guideline on clinical investigation of medicinal products in the treatment of lipid disorder

EMA/CHMP/311805/2014 (pdf,163kb)
Guideline on clinical evaluation of medicinal products used in weight management
To become effective 1 January 2017
To replace: CPMP/EWP/281/96 Rev. 1 Guideline on Clinical Evaluation of Medicinal Products Used in Weight Control

TGA annotation (to be retained):
If a sponsor wishes to claim secondary benefits associated with weight loss (such as improved blood lipids, glycaemic control or blood pressure), then the relevant guidelines for these specific benefits should be independently satisfied.

Anti-infectives for systemic use

EMEA/CPMP/EWP/633/02 Rev. 3 (pdf,213kb)
Guideline on the clinical development of medicinal products for the treatment of HIV infection
To replace: EMEA/CPMP/EWP/633/02 Revision 2 Guideline on the Clinical Development of Medicinal Products for the Treatment of HIV Infection

Biological medicines guidelines

Drug substance

Manufacture, characterisation and control of the drug substance

EMA/CHMP/BWP/3354/1999 rev.1 (pdf,150kb)
Guideline on production and quality control of animal immunoglobulins and immunosera for human use
To replace: CPMP/BWP/3354/99 Note for Guidance on the Production and Quality Control of Animal Immunoglobulins and Immunosera for Human Use

EMA/CHMP/BWP/532517/2008 (pdf,160kb)
Guideline on development, production, characterisation and specification for monoclonal antibodies and related products
To replace: EMEA/CHMP/BWP/157653/2007 Guideline on Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products; and: the quality requirements for monoclonal antibodies set out in the guideline 3AQ21a Radiopharmaceuticals Based on Monoclonal Antibodies; and: EMEA/CHMP/CVMP/362268/2009 Concept Paper on the Revision of the Guideline on Radiopharmaceuticals Based on Monoclonal Antibodies

EMA/CHMP/BWP/187338/2014 (pdf,181kb)
Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

Multidisciplinary guidelines

Cell therapy and tissue engineering

EMA/CHMP/BWP/271475/2006 rev.1 (pdf,127kb)
Guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer
To replace: CHMP/BWP/271475/2006 Guideline on Potency Testing of Cell Based Immunotherapy Medicinal Products for the Treatment of Cancer

Guidelines proposed for non-adoption

  • There are currently no EU guidelines proposed for non-adoption