TGC meeting 21, 11 February 2003
Therapeutic Goods Committee
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Meeting report
TGC 21st meeting (11 February 2003) report (pdf,53kb)
Summary of key resolutions
Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 21st Meeting held on 11 February 2003. It should not be assumed that recommendations made by the TGC to the TGA represent the decisions of the TGA. Reasons underlying the TGC Resolutions will be available in the form of an edited Report following ratification of the Minutes by the Committee.
- Adoption of British Pharmacopoeia 2002
- Child-resistant packaging
- Limits for content of minerals in tablets and capsules specified in Therapeutic Goods Order No. 56
- Medicine labelling - TGA labelling review and performance based labelling
- Standards for haematopoietic stem cell (HSC) products
- New medical devices legislation
- Therapeutic Goods Orders relating to therapeutic devices
- Review of the code of good wholesaling practice for therapeutic goods for human use
Adoption of British Pharmacopoeia 2002
The Therapeutic Goods Committee recommends the adoption of the British Pharmacopoeia 2002 on 1 April 2003 for the purposes of the edition of the British Pharmacopoeia defined under the Therapeutic Goods Act 1989.
The Therapeutic Goods Committee recommends that Therapeutic Goods Order No. 70 Standards for Export Only Medicine be amended to replace the reference to British Pharmacopoeia 2001 with reference to British Pharmacopoeia 2002 with effect 1 April 2003.
Child-resistant packaging
The Therapeutic Goods Committee:
- Endorses the amended draft Therapeutic Goods Order No. 65 Child-resistant packaging for therapeutic goods; and
- Recommends the gazettal of this Therapeutic Goods Order as a standard for therapeutic goods made under section 10 of the Therapeutic Goods Act 1989.
Limits for content of minerals in tablets and capsules specified in Therapeutic Goods Order No. 56
The Therapeutic Goods Committee recommends the following approach be taken by the TGA when considering requests for exemption from the requirements of Therapeutic Goods Order No. 56 General standard for tablets, pills and capsules relating to content limits for minerals contained in multi-mineral and multi-mineral/multivitamin products:
- The permissible limits should be those of the current United States Pharmacopeia (USP) except for those elements which are subject to a Schedule in the Standard for the Uniform Scheduling of Drugs and Poisons;
- For those elements subject to a Schedule in the Standard for the Uniform Scheduling of Drugs and Poisons:
- The USP limits should only apply to those products stated to contain no more than 50 per cent of the scheduled amount;
- In all other cases, the limits that apply should be no less than 90 per cent and no more than 125 per cent of the stated content.
The Therapeutic Goods Committee recommends that:
- At its next Meeting, a Subcommittee be established to review Therapeutic Goods Order No. 56 General standard for tablets, pills and capsules (TGO 56) and associated matters; and
- Before that Meeting, the TGA should canvass stakeholders in order to identify issues for consideration in the review of TGO 56.
Medicine labelling - TGA labelling review and performance based labelling
The Therapeutic Goods Committee gives in-principle support to:
- The linking of Therapeutic Goods Order No. 69 General requirements for labels for medicines to the TGA's proposed document Required Advisory Statements for Therapeutic Goods; and
- The proposal to add a statement on the principles of labelling of non-prescription medicines to Therapeutic Goods Order No. 69 General requirements for labels for medicines with a reference to the Industry Code of Practice Designing medicine labels for people to be included in the Supplementary Notes to the Order.
Standards for haematopoietic stem cell (HSC) products
The Therapeutic Goods Committee establishes an ad hoc Working Party to be chaired by Associate Professor William Rawlinson to:
- Consider the adoption of the 2nd edition of International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release [NETCORD and Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) (July 2001)] as the basis of a Therapeutic Goods Order for Haemopoietic Stem Cells Harvested from Placental Cord Blood;
- Consider the adoption of the 2nd edition of Standards for Hematopoietic Progenitor Cell Collection, Processing & Transplantation [Foundation for the Accreditation of Cellular Therapy (FACT) (2002)] as the basis of a Therapeutic Goods Order for Haemopoetic Stem Cells Harvested from Sources Other than Placental Cord Blood; and
- Provide a report for consideration at the next Meeting of the Therapeutic Goods Committee.
New medical devices legislation
The Therapeutic Goods Committee notes:
- The process for adoption of Medical Device Standards under the new legislation implemented in October 2002;
- The Medical Device Standards proposed for gazettal1;
- The list of standards not recommended for adoption at the present time2; and
- The list of standards which need further consideration3.
Therapeutic Goods Orders relating to therapeutic devices
The Therapeutic Goods Committee notes the gazettal of Therapeutic Goods Order No 67A Amendment to Therapeutic Goods Order No. 67 - Standard for Dental Materials.
Review of the code of good wholesaling practice for therapeutic goods for human use
- The Therapeutic Goods Committee establishes an ad hoc Working Party to be chaired by Professor Stella O'Donnell in order to further develop a revised code for the distribution of therapeutic goods and report to the next Meeting of the Committee.
- The Working Party is to have appropriate representation from relevant stakeholders.
Attachment 1: Medical device/conformity assessment standards proposed for gazettal
| Medical Device/Conformity Assessment Standard |
|---|
| AS EN 556.1-2002 identical to: EN 556-1: 2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
| EN 868-1: 1997 Packaging materials and systems for medical devices which are to be sterilized - Part 1:general requirements and test methods OR ISO 11607: 1997 Packaging for terminally sterilized medical devices |
| AS ISO 11135-2002 Identical to: ISO 11135: 1995 Medical devices - Validation and routine control of ethylene oxide sterilization OR EN 550: 1994 Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization |
| AS ISO 11137-2002 identical to: ISO 11137: 1995 Sterilization of health care products -Requirements for validation and routine control - Radiation sterilization OR EN 552: 1994 Sterilization of medical devices - Validation and routine control of sterilization by irradiation |
| ISO 11134: 1994 Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization OR EN 554: 1994 Sterilization of medical devices - Validation and routine control of sterilization by moist heat |
| AS ISO 14160-2002 identical to: EN ISO 14160: 1998 identical to: ISO 14160: 1998 Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants |
| AS EN 540-2002 identical to: EN 540: 1993 Clinical investigation of medical devices for human subjects OR AS ISO 14155-2002 identical to: ISO 14155:1996 Clinical investigation of medical devices |
| ISO 5840:1996 Cardiovascular implants - Cardiac valve prostheses |
| ISO 11979-7:2001 Ophthalmic implants - Intraocular lenses -- Part 7: Clinical investigations |
| EN ISO 14971:2002 identical to: ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices |
| EN 12442-1: 2000 Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk |
| EN 12442-2: 2000 Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling |
| EN 12442-3: 2000 Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents |
| AS ISO 13485: 2002 identical to: ISO 13485:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9001 |
| AS ISO 13488: 2002 identical to: ISO 13488:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9002 |
| EN 46003: 1999 Quality systems - Medical devices - Particular requirements for the application of ISO 9003 OR AS ISO 13488: 2002 identical to: ISO 13488:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9002 Excluding Clause: 4.9 Process Control |
| AS ISO 9703.1:2002 identical to: ISO 9703-1: 1992 Anaesthesia and Respiratory Care Alarm Signals Part 1 : Visual Alarms Signals |
| AS ISO 9703.2: 2002 identical to: ISO 9703-2: 1994 Anaesthesia and Respiratory Care Alarm Signals Part 2 : Auditory Alarms Signals |
Attachment 2: Medical device/conformity assessment standards not recommended for adoption
These standards are not being adopted either because they are outside the scope of the new medical device legislation or because they are superseded.
| Standard reference | Title | Reason for exclusion |
|---|---|---|
| EN 738-2 | Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators | This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation. |
| EN 737-4 | Medical gas pipeline systems - Part 4: Terminal units for anaesthetic gas scavenging systems | This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation. |
| EN 737-3 | Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases and vacuum | This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation. |
| EN 737-2 | Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems - basic requirements | This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation. |
| EN 737-1 | Medical gas pipeline systems - Part 1: terminal units for compressed medical gases and vacuum | This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation. |
| AS 2896-1998 | Medical gas systems - Installation and testing of non-flammable medical gas pipeline systems | This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation. |
| EN 285 | Sterilization - steam sterilizers - large sterilizers | This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation. |
| AS 1410: 1987 | Sterilizers - Steam - Pre-vacuum | This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation. |
| AS 2192: 2002 | Sterilizers - Steam - Downward displacement | This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation. |
| EN 13220 | Flow-metering devices for connection to terminal units of medical gas pipeline systems | Under consideration |
| AS 4484-1997 | Industrial, medical and refrigerant compressed gas cylinder identification | Bottled medical gases are classified as drugs and hence marking and labelling is not considered within the scope of the new device legislation. |
| EN ISO 4135 | ISO 4135 is Vocabulary for Anaesthesia Incorrect description was quoted - To be resolved | Guideline document only - does not set requirements. |
| EN 1441 | Medical devices - risk analysis | superseded |
| EN 1174-3 | Sterilization of medical devices - Estimation of the population of microorganisms on product - Part 3: Guide to the methods for validation of microbiological techniques | Identified to be outside the scope of the sterility order . |
| EN 1174-2 | Sterilization of medical devices - Estimation of the population of microorganisms on product - Part 2: Guidance | Identified to be outside the scope of the sterility order . |
| EN 1174-1 | Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements | Identified to be outside the scope of the sterility order. |
| AS 1079.1-1993 | Packaging of items (sterile) for patient care - Selection of packaging materials for goods undergoing sterilization | These documents set requirements to be applied by the terminal user but not by the manufacturer. Hence they are considered outside the scope of the new device legislation. |
| AS 1079.2-1994 | Packaging of items (sterile) for patient care - Non-reusable papers - For the wrapping of goods undergoing sterilization in health care facilities | These documents set requirements to be applied by the terminal user but not by the manufacturer. Hence they are considered outside the scope of the new device legislation. |
| AS 1079.3-1994 | Packaging of items (sterile) for patient care - Paper bags - For single use in health care facilities | These documents set requirements to be applied by the terminal user but not by the manufacturer. Hence they are considered outside the scope of the new device legislation. |
| AS 1079.4-1988 | Packaging of items (sterile) for patient care - Flexible packaging systems - For single use in hospitals | These documents set requirements to be applied by the terminal user but not by the manufacturer. Hence they are considered outside the scope of the new device legislation. |
| AS 1079.5-1994 | Packaging of items (sterile) for patient care - Non-reusable, non-woven wrapping materials - For goods undergoing sterilization in health care facilities | These documents set requirements to be applied by the terminal user but not by the manufacturer. Hence they are considered outside the scope of the new device legislation. |
| EN 738-4 | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment | These are considered spare parts, not medical devices. |
| EN 724 | Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices | The European standard EN46000 is now superseded by ISO 13485. The guidance documents are superseded. |
| EN 50103 | Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry | The European standard EN46000 is now superseded by ISO 13485. The guidance documents are superseded. |
Attachment 3: Medical device/conformity assessment standards under consideration
| Standard reference | Title | Comments |
|---|---|---|
| EN 45502-1 | Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer | |
| EN 1280-1 | Agent specific filling systems for anaesthetic vaporizers - Part 1: rectangular keyed filling systems | |
| AS/NZS 3200.1.4:1997 | All available Part 2 - Particular Standards | |
| AS/NZS 4535:1999 | Ambulance restraint systems | |
| ISO 5356-1: 1996 | Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets | |
| EN 1281-1 | Anaesthetic and respiratory equipment - Conical connectors - Part 1: cones and sockets | |
| EN 1281-2 | Anaesthetic and respiratory equipment - Conical connectors - Part 2: screw-threaded weight bearing connectors | |
| ISO 5366-3: 2001 | Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 3: Paediatric tracheostomy tubes | |
| ISO 5356-2: 1987 | Anaesthetic and respiratory equipment; Conical connectors; Part 2 : Screw-threaded weight-bearing connectors | |
| ISO 11196:1995 | Anaesthetic gas monitors and Technical Corrigendum 1:1997 | |
| ISO 5362:2000 | Anaesthetic reservoir bags | |
| ISO 5360: 1993 | Anaesthetic vaporizers; agent-specific filling systems | |
| IEC 60645-2:1993 | Audiometers - Part 2: Equipment for speech audiometry | |
| IEC 60645-3:1994 | Audiometers - Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes | |
| IEC 60645-4:1994 | Audiometers - Part 4: Equipment for extended high-frequency audiometry | |
| AS ISO 10993.1-2002 | Biological evaluation of medical devices - Part 1: Evaluation and testing | EN ISO 10993-1 |
| AS ISO 10993.11-2002 | Biological evaluation of medical devices - Part 11 :Tests for systematic toxicity | ISO 10993-11:1993 |
| AS ISO 10993.3-2002 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | ISO 10993-3:1992 |
| AS ISO 10993.4-2002 | Biological evaluation of medical devices - Part 4 | ISO 10993-4:1992 |
| AS ISO 10993.5-2002 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | ISO 10993-5:1992 |
| AS ISO 10993.6-2002 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation | ISO 10993-6:1994 |
| AS ISO 10993.9-2002 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products | EN ISO 10993-9 |
| AS ISO 10993.10-2002 | Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization | EN ISO 10993-10 |
| AS ISO 10993.12-2002 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials | EN ISO 10993-12 |
| AS ISO 10993.13-2002 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices | EN ISO 10993-13 |
| AS ISO 10993.16-2002 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables | EN ISO 10993-16 |
| AS/NZS 2496: 1995 | Breathing attachments for anaesthetic purposes for human use | |
| ISO 5367: 2000 | Breathing tubes intended for use with anaesthetic apparatus and ventilators | |
| ISO 9918: 1993 | Capnometers for use with humans; requirements | |
| EN 1618 | Catheters other than intravascular catheters - test methods for common properties | |
| AS 2190-1995 | Clinical maximum thermometers - mercury-in glass | |
| EN 12470-3 | Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device | |
| EN 20594-1 | Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: general requirements | |
| AS EN 1642-2002 | Dentistry - Medical devices for dentistry - Dental implants | |
| AS EN 1640-2002 | Dentistry - Medical devices for dentistry - Equipment | |
| AS EN 1641-2002 | Dentistry - medical devices for dentistry - Materials | |
| IEC 60645-1:2001 | Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometers | |
| AS ISO 10535-2002 | Hoists for the transfer of disabled persons - Requirements and test methods | |
| EN ISO 8185 | Humidifiers for medical use - general requirements for humidification systems | |
| EN 1819 | Laryngoscopes for tracheal intubation - particular requirements | |
| AS ISO 7376.1-2002 | Laryngoscopic fittings - Part 1: Conventional hook-on type handle blade fittings | |
| AS ISO 7376.2-2002 | Laryngoscopic fittings - Part 2: Miniature electric lamps - Screw threads and sockets for conventional blades | |
| AS ISO 7376.3-2002 | Laryngoscopic fittings - Part 3: Fibre-illuminated re-usable rigid laryngoscopes | |
| EN 739 | Low pressure hose assemblies for use with medical gases | |
| ISO 10651-4: 2002 | Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators | |
| ISO 10651-2: 1996 | Lung ventilators for medical use - Part 2: Particular requirements for home care ventilators | |
| ISO 10651-3: 1997 | Lung ventilators for medical use - Part 3: Particular requirements for emergency and transport ventilators | |
| ISO 10651-1: 1993 | Lung ventilators for medical use; part 1: requirements | |
| AS/NZS 3200.1.0:1998 | Medical electrical equipment. Part 1: General requirements for safety | |
| AS/NZS 3200.1.1:1995 + Amendment 1 | Medical electrical equipment. Part 1: General requirements for safety - 1. Collateral standard: safety requirements for medical electrical systems | |
| AS/NZS 3200.1.2:1995 | Medical electrical equipment. Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility - requirements and tests | |
| AS/NZS 3200.1.3:1996 | Medical electrical equipment. Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment | |
| AS/NZS 3200.1.4:1997 | Medical electrical equipment. Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems | |
| AS 1600.1-1988 | Medical equipment - Conical fittings with a 6 percent (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements | |
| AS 2120.1: 1992 | Medical suction equipment - Part 1: electrically powered suction equipment - safety requirements | |
| AS 2120.2: 1992 | Medical suction equipment - Part 2: manually powered suction equipment | |
| AS 2120.3: 1992 | Medical suction equipment - Part 3: suction equipment powered from vacuum or pressure source | |
| AS EN 1060.1-2002 | Non-invasive sphygmo-manometers - Part 1: general requirement | |
| AS EN 1060.2-2002 | Non-invasive sphygmo-manometers - Part 2: supplementary require-ments for mechanical Sphygomomanometers | |
| EN 1089-3 | Non-invasive sphygmo-manometers - Part 3: Supplementary requirements for electromechanical blood pressure measuring systems | |
| AS/NZS ISO 15004: 2002 | Ophthalmic instruments - Fundamental requirements and test methods | |
| AS/NZS ISO 11990: 2002 | Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts | |
| EN ISO 8359 | Oxygen concentrators for medical use - safety requirements | AS 3200.2.200-1992 |
| ISO 7767:1997 | Oxygen monitors for monitoring patient breathing mixtures - Safety requirements | |
| AS/NZS 2696:1996 | Polymer Urethral CathetersEN 738-3 Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves | |
| ISO 9919: 1992 | Pulse oximeters for medical use - Requirements EN 12218 Rail systems for supporting medical equipment | |
| AS/NZS 4179: 1997 | Single-use sterile surgical rubber gloves - Specification | based on TGO 53 |
| AS ISO 10555.1-2002 | Sterile, single-use intravascular catheters - Part 1: General requirements | |
| EN 12182 | Technical aids for disabled persons - general requirements and test methods | |
| EN 1282-2 | Tracheostomy tubes - Part 2: paediatric tubes | |
| AS 3693-1989 | Wheelchairs - Nomenclature, terms and definitions | |
| AS 3696.1-1990 | Wheelchairs - Part 1: Determination of static stability | |
| AS 3696.10-1990 | Wheelchairs - Part 10: Determination of obstacle-climbing ability of electric wheelchairs | |
| AS 3696.11-1993 | Wheelchairs - Part 11: Test dummies | |
| AS 3696.13-1991 | Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces | |
| AS/NZS 3696.14:1998 | Wheelchairs - Part 14: Power and control systems for electric wheelchairs - Requirements and test methods | |
| AS 3696.2-1992 | Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs | |
| AS 3696.3-1990 | Wheelchairs - Part 3: Determination of efficiency of brakes | |
| AS 3696.4-1992 | Wheelchairs - Part 4: Determination of energy consumption of electric wheelchairs | |
| AS 3696.5-1989 | Wheelchairs - Part 5: Determination of overall dimensions, mass and turning space | |
| AS 3696.6-1990 | Wheelchairs - Part 6: Determination of maximum speed, acceleration and retardation of electric wheelchairs | |
| AS/NZS 3696.8:1998 | Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths | |
| AS 3696.9-1990 | Wheelchairs - Part 9: Climatic tests for electric wheelchairs | |
| AS 3695-1992 | Wheelchairs - Product requirements |
Supporting documents
Meeting Report, TGC 21
[PDF, 52.88 KB]