Consultations on adoption of European Union guidelines in Australia

6 March 2017

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
WODEN ACT 2606

Guidelines proposed for adoption

This consultation closes on 18 April 2017.

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Quality guidelines

Active substance

EMA/454576/2016 (pdf,204kb)
Guideline on the chemistry of active substances
To become effective: 21 May 2017 (6 months after publication on the EMA website)
To replace: CPMP/QWP/130/96 Rev 1 Guideline on the Chemistry of New Active Substances

TGA proposed annotations:

Under section 4.3.1. Elucidation of Structure and other Characteristics 3.2.S.3.1 Evidence of chemical structure:

The following is also suggested to provide evidence of structure (as per CPMP/QWP/130/96, Rev 1 section 3.2.S.3.1 Elucidation of structure and other characteristics)

  • Optical rotation (absence of optical rotation should be reported if it serves to demonstrate the racemic nature of an asymmetric molecule)

Under section 4.7.3. Stability data 3.2.S.7.3

The forced degradation studies should include results from the Assay and Impurities tests conducted on the same solutions and an assessment of the mass balance obtained under each degradative condition. An explanation should be provided for any mass imbalance exceeding 5%.

Impurities

EMA/CHMP/ICH/82260/2006 (pdf,531kb)*
ICH guideline Q3C (R6) on impurities: guideline for residual solvents
To become effective: 14 June 2017
To replace: EMA/CHMP/ICH/82260/2006 ICH guideline Q3C (R5) on impurities: guideline for residual solvents

Clinical efficacy and safety guidelines

Cardiovascular system

Venous thromboembolism

EMA/CPMP/EWP/6235/04 Rev. 1 (pdf,214kb)
Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in non-surgical patients (formerly CPMP/EWP/6235/04)
To become effective: 1 June 2017
To replace: CPMP/EWP/6235/04 Guideline on Clinical Investigation of Medicinal Products for the Prophylaxis of Venous Thromboembolic Risk in Non-Surgical Patients

Nervous system

EMA/CHMP/970057/2011 (pdf,246kb)
Guideline on the clinical development of medicinal products intended for the treatment of pain
To become effective: 1 July 2017
To replace: CPMP/EWP/252/03 Rev 1 Guideline on Clinical Medicinal Products Intended for the Treatment of Neuropathic Pain; and CPMP/EWP/612/00 Note for Guidance on Clinical Investigation of Medicinal Products for Treatment of Nociceptive Pain

TGA proposed annotations:

Regarding section 5.2.4. Confirmatory efficacy studies (acute and chronic pain): Add-on treatments and combination treatments.

... In a standard trial design patients are randomised to receive either active test treatment or placebo, in addition to open label standard of care (SOC) including a dose optimised standard pharmacological therapy approved in the EU for the target pain condition.

Sponsors should consult with the TGA before submission to discuss acceptable standard of care pharmacological therapies for confirmatory efficacy studies involving add-on and combination treatments.

Regarding section 6.5 Fybromyalgia Syndrome

... Regional differences in medical and social culture largely preclude extrapolation of data from non-EU studies.

Sponsors should consult with the TGA before submission to clarify the acceptability of such studies in the Australian setting.

Other guidelines to be endorsed by TGA

EMA/CHMP/CVMP/JEG-3Rs/450091/2012 (pdf,177kb)
Guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches

Guidelines proposed for non-adoption

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