Consultations on adoption of European Union guidelines in Australia

10 April 2018

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
Prescription Medicines Authorisation Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

Guidelines proposed for adoption

Closing date: 22 May 2018

How to access a pdf document

Quality

Specifications, analytical procedures and analytical validation

  • EMA/CHMP/CVMP/QWP/336031/2017

    Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action

    Effective: 10 August 2017

  • EMA/651649/2010

    Reflection paper on considerations given to designation of a single stereo isomeric form (enantiomer), a complex, a derivative, or a different salt or ester as new active substance in relation to the relevant reference active substance

    Effective: 18 October 2012

  • EMA/CHMP/CVMP/QWP/826771/2016 Corr. 1

    Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances

    Effective: 3 July 2017

  • EMA/CHMP/QWP/104223/2015

    Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances.

    Effective: 17 December 2015

  • EMA/CHMP/703715/2012 Rev2

    Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man Condition specific guidance

    TGA annotation

    Part 7 on minimal residual disease as an endpoint in chronic lymphocytic leukaemia studies is currently under consideration for adoption.

  • COMP/431/01 (pdf,171kb)

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

    Adopted: 26 March 2002

    TGA annotation

    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.

  • EMA/CHMP/SWP/620008/2012 (pdf,131kb)

    Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product

    Effective: 26 March 2015

  • EMA/CHMP/BWP/310834/2012 Rev. 1

    Influenza vaccines - quality module

    Adopted: 1 February 2018

    TGA annotation

    The TGA has published an explanatory document to support the submission of quality modules as part of registration applications for influenza vaccines (Category 1 applications), and/or variation applications for annual strain updates to seasonal influenza vaccines (Category 3 applications), in reference to EMA/CHMP/BWP/310834/2012.

    This document also applies to relevant sections in EMA/CHMP/BWP/310834/2012 Rev. 1 (pdf,345kb).

  • EMA/CHMP/302620/2017

    Updated Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use (pdf,130kb)'.

    Effective: 1 October 2017

    Ethanol in medicines for children

    TGA annotation

    TGA adopts the European Commission annex to the guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' with regard to ethanol. There is currently no guidance in Australia, on safe limits for ethanol/alcohol in medicines for the paediatric population. Guidance on dosage is intended to establish ethanol labelling thresholds for children to avoid a blood alcohol concentration (BAC) that is higher than 0.125 g/L because of the following risks:

    • ingestion of acute doses (risk of mortality & toxicity)
    • cumulative effects from long-term exposure that occurs during therapy for chronic conditions/long term use
    • alcohol exposure during brain development
    • mis-dosing or overdosing of alcohol-containing medicines in children, particularly from those containing high concentration of alcohol.

    According to information published by the EMA, ethanol should not be included in medicinal products intended for children unless necessary. If used in children, the amount of ethanol should not produce blood alcohol (ethanol) concentration (BAC) greater than 0.125 g/L (0.0125%). Refer to the EMA's draft Questions and Answers on Ethanol in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00) for more information on BAC calculations.

  • EMA/CHMP/302620/2017 (pdf,131kb)

    Updated Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' with regard to Boric acid (and borates) (pdf,130kb)

    Effective: 9 October 2017

    Boric acid (and borates)

    TGA annotation

    The TGA is adopting the European Commission annex to the guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' with regard to Boric acid (and borates). The guidelines will help to address dose-related developmental and reproductive risks to children under 12 years of age and unborn foetus', associated with the use of boric acid (and borates).

    While the Australian Poisons Standard specifies a Schedule 4 limit of 6mg Boron per recommended daily dose, the EU Guideline entries for Boric acid (and borates) provides lower limits of Boron (B) for children less than 2 years (1 mg B/day), children less than 12 years (3 mg B/day) and unborn infants. The current level of 6 mg/day in people over the age of 12 years (other than pregnant women) will remain.

Guidelines proposed for non-adoption

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