TGC meeting 35, 14 October 2009

Meeting report

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TGC 35th meeting (14 October 2009) meeting report (pdf,179kb)

Summary of key resolutions

Minutes of the 34th meeting of the TGC

The Therapeutic Goods Committee (TGC) NOTES that:

• the Minutes of the 34th Meeting of the TGC, held on 13 May 2009, were ratified out-of-session in July 2009 as a true and accurate record of that Meeting; and
• the documents Summary of Key Resolutions and Information for Stakeholders Report on Meeting were published on the TGA website in June and July 2009 respectively,

in accordance with usual practice.

Subcommittee reports

Subcommittee on Biologicals

The Therapeutic Goods Committee (TGC) NOTES that the Subcommittee on Biologicals has met twice since the last TGC Meeting, and that the Subcommittee is progressing its Terms of Reference.

Subcommittee on Packaging Requirements for Therapeutic Goods

The Therapeutic Goods Committee NOTES that:

• the report of Meeting 2 of the Subcommittee on Packaging Requirements for Therapeutic Goods for Human Use, which was held on 20 March 2009, has been ratified by the Subcommittee; and
• the Therapeutic Goods Administration is progressing action items identified by the Subcommittee.

Status report on additional default standards under the Act

The Therapeutic Goods Committee NOTES that amendments to the Therapeutic Goods Act 1989 to adopt the British Pharmacopoeia, the European Pharmacopoeia and the United States Pharmacopeia-National Formulary as default standards for medicines and other therapeutic goods that are not medical devices took effect on 1 July 2009.

Therapeutic Goods Order No. 80 Child-resistant packaging requirements for medicines - Annual review of Schedule 1 (medicines to which the order applies)

1. The Therapeutic Goods Committee (TGC) RECOMMENDS that the Therapeutic Goods Administration (TGA) consult with stakeholders on the proposal that Schedule 1 to Therapeutic Goods Order No. 80 Child-Resistant packaging Requirements for Medicines (TGO 80) be amended to:
   1. include a new class entry for 'Angiotensin II Antagonists', with the following substances listed as examples: candesartan, eprosartan, irbesartan, olmesartan, telmisartan, and valsartan;
   2. include the following additional examples for classes already included in Part 1 to Schedule 1:
      • Antidepressants - desvenlafaxine, duloxetine
      • Antiepileptics - lacosamide, zonisamide
      • Antihistamines - levocetirazine
      • Antineoplastic agents - dasatinib, erlotinib, lapatinib, nilotinib, sorafenib, sunitinib
      • Anti-Parkinson drugs - rotigotine
      • Antipsychotics - paliperidone
      • Antithrombotic agents - dabigatran, rivaroxaban
      • Beta blocking agents - nebivolol
      • Oral blood glucose lowering agents - sitagliptin;
   3. re-title the existing class entry for 'Benzodiazepine Derivatives' as 'Benzodiazepine Derivatives and Benzodiazepine Related Drugs' and include the following substances as additional examples: zolpidem, zopiclone and zaleplon;
   4. include new individual entries for:
      • aliskiren
      • ambrisentan
      • azadirachta indica in preparations for human dermal use; and
      • bosentan
      • chloral hydrate
      • cilostazol
      • deferasirox
      • ivabradine
      • lanthanum
      • lenalidomide
      • prasugrel
      • sitaxentan
      • solifenacin
      • varenicline; and
   5. amend the existing individual entry for methyl salicylate in liquid preparations to remove the concentration cut-off below which child-resistant packaging is not required.
2. The TGC:
   1. NOTES:
      1. the stakeholder consultation soon to be undertaken by the TGA on a series of proposed changes to requirements for medicines for the treatment of the symptoms of cough and cold in children, and that the proposals on which comment is to be sought in that consultation include a recommendation that, commencing on 1 July 2010, all over-the-counter cough and cold medicines should be marketed in containers with child-resistant closures;
      2. that TGO 80 already requires a number of substances used in cough and cold medicines to have child-resistant packaging, but the following additional substances may be affected:
         • Antitussives - Dextromethorphan, Pentoxyverine, Pholcodine
         • Expectorants/Mucolytics - Ammonium chloride, Bromhexine, Guaifenesin, Ipecacuanha, Senega and ammonia
         • Decongestants - Oxymetazoline, Xylometazoline; and
   2. REQUESTS that the TGA provide, for consideration by the TGC, responses to the consultation that are relevant to the consideration of requirements for child-resistant packaging of cough and cold medicines, together with supporting data.
3. The TGC REQUESTS that the TGA investigate the availability of child-resistant closures for small volume dropper and spray bottles as commonly used to package eye drops and nasal decongestants, and for tubes commonly used to package creams and other semi-solid preparations.
4. The TGC RECOMMENDS that the TGA explore whether assessments of safety in children following accidental ingestion can be made in conjunction with the evaluation of new chemical entities for registration, in order to allow the TGC to make appropriately informed packaging recommendations at the earliest possible time.

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Medicine labelling

Update on medicine labelling matters previously considered by TGC

The Therapeutic Goods Committee (TGC):

1. NOTES:
   1. the intention of the Therapeutic Goods Administration (TGA) to conduct a single stakeholder consultation addressing all proposed amendments to Therapeutic Goods Order No. 69 General requirements for labels for medicines, and
   2. this consultation will follow finalisation of the TGC's consideration of labelling matters that were identified by the Committee at its 33rd Meeting during consideration of stakeholder comments on the draft Therapeutic Goods Order on medicine labelling [Therapeutic Goods Order No. 79 General Requirements for the Labelling of Medicines (TGO 79) (draft)].
2. SUPPORTS the conduct by the TGA of an industry survey aimed at developing a schedule of cost estimates associated with various labelling changes affecting medicines.

Medicine labelling - Trace elements as mineral supplements

The Therapeutic Goods Committee:

1. CONFIRMS that the intention of the requirement given in subclause 4(12) of Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69) is that the quantity of trace element present as an active ingredient in any supplement preparation be expressed in terms of the quantity of the element present, with the name of the salt being indicated, irrespective of the intended purpose of the particular trace element.
2. RECOMMENDS that:
   1. subclause 4(12) of TGO 69 be amended to clarify this intention, and
   2. the Therapeutic Goods Administration undertake stakeholder consultation on this proposal to amend TGO 69 as required.

Medicine labelling - Expressions of potency

The Therapeutic Goods Committee (TGC):

1. NOTES the recommendation made by the TGC at its 34th Meeting that Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69) should be amended to require that, where potency units are used on labels as a measure of activity, the potency must be expressed in terms of International Units (IU) as established by the World Health Organization, and that the Therapeutic Goods Administration should consult with stakeholders on an amendment to TGO 69 that would have this effect.
2. ADVISES that the intention of this recommendation was to ensure that where both International Units (IU) and United States Pharmacopeia Units (USP Units) exist as a measure of potency for a substance then, for patient safety reasons and to ensure consistency in labelling, TGO 69 should require the label to declare the potency in terms of International Units (IU) only.

Medicines labelling - Update to Edition of Required Advisory Statements for Medicine Labels (RASML) referenced in Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69)

The Therapeutic Goods Committee (TGC):

1. NOTES that:
   1. the definition of Required Advisory Statements for Medicine Labels (RASML) contained in Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69) currently refers to the September 2008 version of RASML, and
   2. the Therapeutic Goods Administration (TGA) undertook stakeholder consultation in July-August 2009 on a proposed update to the September 2008 version of RASML.
2. RECOMMENDS that:
   1. subject to gazettal by the TGA of the updated version of RASML, the definition of 'Required Advisory Statements for Medicines' contained in clause 2 'Interpretation' of TGO 69 should be amended to refer to the updated version of RASML; and
   2. this proposal to amend the definition of 'Required Advisory Statements for Medicines' contained in TGO 69 should be included in the stakeholder consultation to be undertaken by the TGA on all proposed amendments to TGO 69 resulting from TGC recommendations.

Medicine labelling - Batch and expiry dating of plastic ampoules

The Therapeutic Goods Committee RECOMMENDS that:

1. for safety reasons, the batch number displayed on plastic ampoules which are joined to a connecting strip should appear on the ampoule itself rather than the connecting strip, irrespective of whether the seal on the ampoule is broken when an ampoule is detached.
2. for safety reasons, all plastic ampoules should be required to display the applicable expiry date together with the batch number.
3. subclause 3(17) of Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69), relating to requirements for plastic ampoules, should be amended to adjust the nominal volume at which concessions for ampoules joined to a connecting strip apply, to extend these to ampoules with a nominal volume of precisely 5 millilitres.
4. provisions for plastic ampoules with nominal volume of 5mL or less, and which are not joined by a connecting strip, need not be included in subclause 3(17) of TGO 69.
5. at the present time reformatting of subclause 3(17) of TGO 69 to improve clarity, as proposed in the consultation document Therapeutic Goods Order No. 79 General Requirements for the Labelling of Medicines (draft) [TGO 79 (draft)], is unwarranted.

Medicine labelling - Expression of quantity or proportion of active ingredient in transdermal patches

The Therapeutic Goods Committee:

1. NOTES:
   1. the proposal included in the consultation document Therapeutic Goods Order No. 79 General Requirements for the Labelling of Medicines (draft) [TGO 79 (draft)] for labels of transdermal patches to declare the quantity of active ingredient in each patch both as the total quantity of the active ingredient in each patch, and the quantity of the active ingredient released in a stated time; and
   2. that this proposal originally arose in the context of the new labelling order being developed for application under the proposed, but now postponed, joint Australia and New Zealand regulatory scheme for therapeutic goods; but
2. RECOMMENDS that, at this time, there is insufficient justification to amend Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69) to impose this new requirement for the labelling of transdermal patches.

Medicine labelling - Expression of quantity or proportion where active ingredient is a herbal extract

The Therapeutic Goods Committee RECOMMENDS that consideration of proposed amendments to labelling requirements for herbal medicines, as given in the consultation document Therapeutic Goods Order No. 79 General Requirements for the Labelling of Medicines (draft) [TGO 79 (draft)], including the expression of quantity where an active ingredient is a herbal extract, should be set aside for future consideration in the broader context of the regulation of herbal medicines.

Medicine labelling - Route of administration for injections and other medicines contained in ampoules

The Therapeutic Goods Committee RECOMMENDS that, for safety reasons, Therapeutic Goods Order No. 69 General requirements for labels for medicines should be amended to require the label on all medicines presented in ampoules to state the approved route(s) of administration for the medicine.

Medicine labelling - Legibility requirements including colour contrast and embossing/debossing

The Therapeutic Goods Committee (TGC):

1. NOTES:
   1. that correspondence received by the Therapeutic Goods Administration (TGA), and responses to the consultation document Therapeutic Goods Order No. 79 General Requirements for the Labelling of Medicines (draft) [TGO 79 (draft)], reveal ongoing concerns among consumers and health professionals over the visibility and legibility of batch numbers and expiry dates on the labels of medicines; and
   2. these concerns exist despite the requirement of Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69) for all label particulars to be clearly visible and written in legible characters, and the advice contained in the TGA document Best Practice Guideline on Prescription Medicine Labelling, that ink is preferred over embossing.
2. RECOMMENDS that the Therapeutic Goods Administration develop a proposal, for consultation with stakeholders, for an amendment to TGO 69 that would introduce a mandatory requirement for colour contrast for batch and expiry details on all container types.

Medicine labelling - Requirements/concessions for small and very small containers/injections

The Therapeutic Goods Committee:

1. NOTES:
   1. the proposals included in the consultation document Therapeutic Goods Order No. 79 General Requirements for the Labelling of Medicines (draft) [TGO 79 (draft)] relating to the labelling of small and very small volume containers and equivalent size injections and the considerations leading to development of those proposals, and
   2. stakeholder comments received in response to the consultation on TGO 79 (draft) in relation to these proposals.
2. CONCLUDES that amending requirements for the labelling of small and very small volume containers and equivalent size injections as proposed would not have the desired effect of simplifying labelling requirements for medicines packaged in these size containers.
3. RECOMMENDS that amendment to Therapeutic Goods Order No. 69 General requirements for labels for medicines relating to requirements for small and very small volume containers and equivalent size injections (other than where identified in other recommendations) is not justified at this time.

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Medicine labelling - Requirements/concessions for strip, blister and dial dispenser packs and individually wrapped goods

The Therapeutic Goods Committee RECOMMENDS that:

1. Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69) should be amended to require that, except for calendar packs, the name of the medicine, together with active ingredient details, is repeated on strip, blister and dial dispenser packs at least once every two dosage units irrespective of whether or not there are perforations between dosage units to facilitate individual segments being detached; and
2. other changes proposed in the consultation document Therapeutic Goods Order No. 79 General Requirements for the Labelling of Medicines (draft) [TGO 79 (draft)] for the labelling of individually wrapped goods and strip, blister and dial dispenser packs are not warranted at this time, and difficulties experienced by industry in compliance with the requirements of TGO 69 for medicines packaged in this way should continue to be assessed by the TGA on a case by case basis.

Medicine labelling - Space allowance on prescription medicines for a dispensing label

The Therapeutic Goods Committee (TGC):

1. NOTES:
   1. the recommendation, contained in the Therapeutic Goods Administration (TGA) document Best Practice Guideline on Prescription Medicine Labelling, for there to be a clear space on the label of prescription medicines for attachment of the pharmacist's dispensing label; and
   2. that a number of unsolicited requests have been received for this recommendation of the Best Practice Guideline on Prescription Medicine Labelling to become a mandatory requirement through amendment to Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 60).
2. RECOMMENDS that the TGA develop a proposal, for consultation with stakeholders, for amendment to TGO 69 that would have the effect of requiring that the labels of as many prescription medicines as possible have adequate clear space for attachment of a dispensing label.

Medicine labelling - Statement of volume and expression of strength on injections

The Therapeutic Goods Committee:

1. NOTES the proposal included in the consultation document Therapeutic Goods Order No. 79 General Requirements for the Labelling of Medicines (draft) [TGO 79 (draft)] to require the label on injections having a nominal volume greater than 1 millilitre to express the content of active ingredient as both the total quantity of active ingredient in the total volume of the injection, and the quantity of the active ingredient in one millilitre of the injection; but
2. ADVISES that amendment to Therapeutic Goods Order No. 69 General requirements for labels for medicines relating to the expression of content of active ingredient in medicines for injection as proposed in TGO 79 (draft) is not supported at this time.

Medicine labelling - Expression of strength on liquids for oral administration

The Therapeutic Goods Committee:

1. NOTES the proposal from a stakeholder for an amendment to Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69) to require the label on liquids for ingestion to express the content of active ingredient in terms of the quantity of active ingredient contained in one millilitre of the liquid, but
2. ADVISES that amendment to TGO 69 relating to the expression of content of active ingredient in medicines for ingestion, as proposed, is not supported at this time.

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Therapeutic Goods Order No. 78 Standard for tablets and capsules - Response to the adoption of additional default standards

The Therapeutic Goods Committee:

1. NOTES that:
   1. Therapeutic Goods Order No 78 Standard for Tablets and Capsules (TGO 78) took effect on 7 November 2008 and medicines within its scope must comply with the Order by 1 November 2010, and
   2. changes to the Therapeutic Goods Act 1989 to recognise the British Pharmacopoeia (BP), the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia-National Formulary (USP) as default standards took effect on 1 July 2009.
2. RECOMMENDS that TGO 78 be amended such that:
   1. references to the BP be amended to refer to the BP, Ph. Eur. and/or USP as appropriate;
   2. the statement in USP Dietary Supplement monographs for multivitamin and multimineral products allowing the inclusion of 'other labeled added substances that are generally recognized as safe, in amounts that are unobjectionable' be allowed, subject to compliance with the limits that otherwise apply to listed and registered tablets and capsules for the content of those added active ingredients; and
   3. the USP's Dietary Supplement test for weight variation be accepted in place of Uniformity of Dosage Units for listed medicines otherwise compliant with a USP monograph;
3. NOTED the following proposals and SUPPORTED their inclusion as proposed amendments to TGO 78 for stakeholder consultation:
   1. compliance with a USP Dietary Supplement monograph be required in full (except Uniformity of Dosage Units, where applicable) for listed and registered complementary medicines;
   2. Schedule 1 be applied to both listed and registered complementary medicines, including those that have a USP monograph;
   3. registered complementary medicines that are multivitamin and/or multimineral tablets and capsules need not demonstrate dissolution of every active ingredient;
   4. 90.0-110.% limits be applied for the content of active ingredients in registered medicines not subject to an individual pharmacopoeial monograph, in conjunction with Uniformity of Dosage Units requirements;
   5. chewable registered tablets be required to comply with a dissolution requirement; and
4. SUPPORTED IN PRINCIPLE, subject to further consultation, that TGO 78 be extended to include standards for the dosage form 'pills' and that the requirements of the Pharmacopoeia of the People's Republic of China, Volume 1 be considered for application to listed pills of the types described in that pharmacopoeia.

Orders relating to exclusion of certain United States Pharmacopeia monographs

The Therapeutic Goods Committee:

1. NOTES that the Therapeutic Goods Administration has commenced public consultation with interested parties on:
   1. draft Therapeutic Goods Order Standard for human albumin,
   2. draft Therapeutic Goods Order Standard for water for injection for parenteral medicines, and
   3. draft Order under section 3C(1) of the Act, and
2. AGREES to consider submissions on the draft Orders at its next meeting.

Update on the development of product standards for the new regulatory framework for biologicals

The Therapeutic Goods Committee NOTES progress towards the development of standards for human blood and blood components, tissues and cell therapies.

Manufacturing Principles - good manufacturing practices for medicinal products

The Therapeutic Goods Committee NOTES that a new Manufacturing Principle has been determined under Subsection 36(1) of the Therapeutic Goods Act 1989 to adopt the current Pharmaceutical Inspection Convention and Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products.

Draft Therapeutic Goods Order - Standard for heparin

The Therapeutic Goods Committee:

• NOTES that the Therapeutic Goods Administration has commenced public consultation with interested parties on the draft Therapeutic Goods Order Standard for Heparin, and
• AGREES to consider submissions on the draft Order out of session.

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