Amendments to Therapeutic Goods Advertising Code

The Therapeutic Goods Advertising Code Council (TGACC) recently recommended amendments to the Therapeutic Goods Advertising Code (TGAC).

Amendments to Clause 3.4 of the TGAC were proposed to enable specific product names to be used in the mandatory Schedule 3 advertising statement. In addition, amendments were proposed for a number of prohibitions listed in Clause 4. These include references to cardiovascular ailments (to permit a statement indicating that cessation of smoking may reduce the risk of cardiovascular events linked to smoking), psoriasis (amending the mandatory warning statement to prevent any confusion arising in respect to the duration of treatment) and genito-urinary system ailments (to make it consistent with the Therapeutic Goods (Excluded Goods) Order No. 1 of February 1998 with regard to absorbent pads and protective mats).

In relation to vitamin products, amendments to Clauses 6.1.1 and 6.1.2 were proposed to assist in clarifying the Code and Clause 6.2 was deleted. The mandatory vitamin statement for oral preparations is still required under Schedule 2, Part 2 of the Therapeutic Goods Regulations. However, an amendment to permit an alternative statement and limit the statement to labels only is currently under consideration. A number of amendments were proposed to the Clause 4 mandatory statements containing references to healthcare professionals in the interests of consistency.

All of the TGACC's recommendations were accepted and the amendments became effective on 28 April and 9 June 1999. The majority of the above amendments provide sponsors with a wider scope of advertising claims which may be included in advertisements to the public for non-prescription products.

Australian Approved Names (AAN) - harmonisation with British Pharmacopoeia 1998 (BP98)

The TGA has consulted with industry to develop a detailed strategy to cover changes to the name of 110 ingredients used in therapeutic goods in Australia. An implementation date for the changes is yet to be finalised, but will hinge on developments in the United Kingdom and advice from the Medicines Control Agency.

Why change?

On 1 December 1998, the BP98 became the edition of the pharmacopoeia referenced by the Therapeutic Goods Act 1989. This made the BP98 the standard for therapeutic goods in Australia unless the good was subject to a specific Therapeutic Goods Order.

Where ingredients are declared on the label, Therapeutic Goods Order No. 48 "General requirements for labels for therapeutic goods" requires they be expressed as Australian Approved Names (AAN). Under the Order, all active and certain excipients must be declared on the labels. Ingredients are also recorded, using approved terminology, in Consumer Medicine Information (CMI) and Product Information (PI) documentation.

BP98 changed a number of names to International Non-Proprietary Names (INNs). This will impact on the AAN, requiring them to change from their existing names to the names now required by the BP.

Two categories of change to ingredient names are proposed. They are:

Part A -

names where dual naming (old and new names) is required on labels (eg. adrenaline (old) epinephrine (new))

Part B -

names where the old name is being replaced by the new name (eg. riboflavine (old) riboflavin (new))

The TGA in consultation with industry has produced a strategy, proposing transition periods of up to 7 years for Part A names and 3 years for Part B names.

The key to the implementation strategy will be an extensive education program utilising industry and health professionals to inform consumers of the name changes.

Current status

Implementation of the new names in Australia has been deferred pending confirmation from the Medicines Control Agency that the new nomenclature will be given legal status within the UK and its implementation timetable.

Accordingly, sponsors should NOT move to the revised BP ingredient names nomenclature until advised by the TGA.

Top of page

Changes to therapeutic goods legislation (since 1 July 1998)

Act	Date of change / Date of effect
Therapeutic Goods Legislation Amendment Act 1999, - No.3, 1999	1 April 1999
Regulations	Date of change / Date of effect
62 of 1999	16 April 1999
369 of 1998	1 January 1999
227 of 1998	16 July 1998
247 of 1998	1 August 1999
Instruments	Date of change / Date of effect
S3 - Definition of British Pharmacopoeia	1 December 1998
S10 - TGO (Therapeutic Goods Order)	1 December 1998
S10 - TGO (Therapeutic Goods Order)	8 July 1998
S36 - Manufacturing principles	1 January 1999
S36 - Manufacturing principles	7 December 1998
Reg 2 - Advertising Code	3 February 1999
Reg 2 - Advertising Code	28 April 1999
Reg 2 - Advertising Code	9 June 1999
Section 7 determinations - included goods orders	Date of change / Date of effect
No. 4 of 1999 - HMB	14 April 1999
No. 3 of 1999 - products containing shark cartilage	14 April 1999
No. 2 of 1999 - cosmetic purposes presented for oral consumption	1 March 1999
No. 1 of 1999 - fibre	3 March 1999
No. 1 of 1998 - Cellasene	3 December 1998

Top of page

Department of Industry Science and Resources EC-MRA seminars 8 and 10 June 1999 - A saga of CE marking

The Department of Industry, Science and Resources recently held seminars on Trading with Europe, to explore the Mutual Recognition Agreement with Europe in relation to conformity assessment and what it means for Australian exporters. The seminars were held in association with the Delegation of the European Commission to Australia and New Zealand, and were conducted in Sydney and Melbourne. Several TGA staff attended; Robert Tribe conducted a Workshop on Pharmaceutical GMP, and Keith Smith, Michael Flood and Anthony Gould conducted the Workshop on medical devices.

Keith Degenhardt, of Ellex Laser Systems, in Adelaide, presented a case study of his company's path to CE marking for their solid-state ophthalmic surgical YAG laser device. The product has been well established in Europe for some years, but had trouble breaking into the German and French market in particular because of the complexity of regulatory requirements. In late 1995, the company launched an operation to get the product CE marked and contracted a European Notified Body. However, the Australian office of the Notified Body had no experience or understanding of the Medical Devices Directive. Overseas experts were assigned, but assessment visits were postponed several times.

Ellex then went to another Notified Body (NB) represented by an Australian office. This office seemed at first to know what they were doing, but relations gradually deteriorated. Ellex was issued with an ISO 9002 certificate, but the overseas NB determined that the local office auditors were not qualified or certified to audit to EN 46000. The company underwent three audits conducted by the local office, all of which were acceptable, but EN 46000 certificates were not issued until an overseas auditor was brought in. Type testing was still required in order to complete the process. The company worked with a local testing facility, but the NB decided that the product had to be tested in their laboratories in the USA. The NATA certificates obtained for the product in Australia were rejected. Ellex was now locked out of Europe.

It was at about this time that the MRA came into force. Ellex contacted TGA, and for the first time found people who understood the requirements of the European system, and who shared the company's objectives of getting the product CE-marked. TGA had highly skilled technical people, including an expert in medical lasers. The company established a cooperative working relationship with the TGA, and the assessment process went smoothly. The only hitch was a brief delay in Europe of the publication of TGA as a recognised Conformity Assessment Body; until this was done, TGA could not issue certificates of conformity.

Mr Degenhardt concluded with the comments that the interpretation of MDD requirements by consultants is variable, and the company's initial experiences led them to believe that the objective was to keep them out of the European market. The European Notified Bodies appeared to promote their own chosen paths, rather than allow the company to control the process. He stated that the TGA's knowledge is greater than that of any of the Notified Bodies with which his company has come into contact.

Top of page

European regulatory system - useful Internet sites

Manufacturers and sponsors are reminded that free copies of many useful documents such as the Medical Device Directives (93/42/EEC) and lists of Standards may be obtained from the Internet. Some useful internet sites include:

European Organisation for Testing and Certification (EOTC)

http://www.eotc.be/

Includes:

• Secretariat for the European Notified Bodies Group;
• EOTC News
• Notification of new documents form the EU Commission re Conformity Assessment;
• Notification of meetings, conferences and workshops relating to Conformity Assessment;
• Guidance document on the New Approach and Global approach Directives - Version 1 DRAFT

Delegation of the European Commission to Australia and New Zealand

http://www.delaus.ec.europa.eu/

Includes:

• Document - EU/Australia or EU/New Zealand MRA;
• Document - "The European Union Standards and Conformance Assessment System - A guide for Australian and New Zealand Manufacturers and Exporters";
• Document - "CE Marking of Australian and New Zealand Products for Export to the European Union".

German Institute for Medical Documentation and Information

http://www.dimdi.de/dynamic/en/index.html

Includes:

• EUDAMED Registration Program for MDD Article 14 (Class I, custom made) medical devices. Includes UMDNS lookup tables.

CEN, CENELEC and ETSI joint homepage

http://www.newapproach.org/

Includes:

• European New Approach Directives and corresponding relevant Harmonised Standards.
• Links to CEN, CENELEC and ETSI Joint Homepage.

Medical Devices Agency

http://www.medical-devices.gov.uk/

Includes:

• Guidance documents for the European Directives;
• Registration forms for persons placing devices on the market in the UK.

EUR-LEX

http://eur-lex.europa.eu/en/index.htm

Includes:

• Free Texts of European Law.

European Confederation of Medical Device Associations

http://www.eucomed.be

Includes:

• List of guidance documents available on the interpretation of the EU Directives for Medical Devices;
• Risk Assessment of Medical Devices;
• CE Marking of Medical Devices.

Note: TGA is providing this information as a reference only. Manufacturers should not rely on the TGA or the Commonwealth in relation to the existence, content or effect of:

• The EC directives;
• Other laws/directives or guidelines of the European Community or other organisations; or
• National laws of member states of the European Community.

Top of page

Formal opening of the National Serology Reference Laboratory

The continued improvement in safety of blood supplies and reliability of diagnostic testing for HIV and other communicable diseases has been ensured with the opening of the new premises for the National Serology Reference Laboratory (NRL).

The Federal Minister for Health and Aged Care, Michael Wooldridge and the Parliamentary Secretary to the Minister for Health Victoria, Robert Doyle, officially opened the new NRL facilities at St Vincent's Institute of Medical Research in Melbourne on 9 April 1999.

The NRL is recognised as a "Centre of Excellence" in testing for blood-borne pathogens and makes a valuable contribution towards the assessment of diagnostic test kits and providing quality assurance on their use.

The TGA National Manager, Terry Slater, Acting Director of the Conformity Assessment Branch, Rita Maclachlan, Director of the Australian Radiation Laboratory, John Cable and Head of the Blood Products Section, Albert Farrugia all attended the opening.

A Scientific Forum on New Diagnostic Technologies for Emerging Diseases was also held on the day featuring presentations from Professor Colin Masters, Professor James McCluskey and Professor Ian Gust. The Forum was chaired by Professor David Pennington.

German delegation visit to TGA

A German delegation comprising members of the organisations affiliated with the German Competent Authority visited Australia in late March this year. Members of the delegation are involved in designating conformity assessment bodies (CABs) participating in the Australia-EC Mutual Recognition Agreement (MRA). Their visit to the TGA included discussions on the European and Australian legal, technical and administrative provisions for the supply of medical devices and the criteria for assessing competency of CABs.

While in Australia, the German delegation also met with the Manager of the National Association of Testing Authorities, Australia and visited the National Serology Reference Laboratory in Melbourne.

(from left to right) Norbert Feitenhansl, Terry Slater (National Manager, TGA), Undine Soltau and Johan Deitrich

Top of page

GMP training for Vietnamese delegates

Three Vietnamese pharmacists visited Australia for three weeks during May for Good Manufacturing Practice (GMP) training organised by the Good Manufacturing Practice Audit and Licensing Section (GMPALS) and the International Services Branch (ISB) of the Therapeutic Goods Administration.

They were Pharmacist Ta Thi Phuc Chan, Head of Drug Quality Management Division, Drug Administration of Vietnam, Pharmacist Tran Duc Chinh, GMP Auditor and Head of the Drug Information Division Drug Administration of Vietnam, and Doctor Trinh Van Lau the Deputy Director of the Vietnamese National Institute of Drug Quality Control (NIDQC).

The NIDQC is TGA Laboratories' equivalent but as well as the Hanoi central laboratory it has 61 regional laboratories to look after with a total of over 700 staff.

The visitors' training schedule saw them spend a week in Canberra with courses arranged by the TGA Laboratories and GMPALS and two weeks in Sydney observing GMP audits and attending a filter theory and validation course.

The delegates were very impressed with Australia and TGA, especially the TGA building and the organisation and construction of the TGA Laboratories. They indicated they would like to return and send other staff members over for further training.

National Drugs and Poisons Schedule Committee (NDPSC) - Working Party on Trans-Tasman Harmonisation Scheduling of Drugs and Poisons

• The Working Party's Technical Information Sheet No 2/99 outlines the legislation, principles and processes under which the NDPSC Working Party is operating. It also describes some issues where differences have arisen related to the harmonisation of scheduling of "prescription only" medicines in Australia and New Zealand (NZ).
• This article is an abridged version of that document. The unabridged version is available on this Internet site or from the TGA Information Officer on 1800 020 653 or fax 02 6232 8605.

Principles of harmonisation of scheduling of drugs and poisons

• The Working Party's activities sit within the framework of the Trans-Tasman Mutual Recognition Act 1998, the Co-operation Program for Therapeutic Goods (coordinated by the Therapeutic Goods Administration) and the Council of Australian Governments' (COAG) Principles and Guidelines for National Standard Setting and Regulatory Action
• The National Co-ordinating Committee on Therapeutic Goods (NCCTG) provides overall policy direction to the NDPSC. In 1998 the NCCTG established a set of principles that are followed by the NDPSC Working Party in the harmonisation of scheduling of drugs and poisons. The Working Party's recommendations are then considered by the NDPSC and the New Zealand Medicines Classification Committee in accordance with their usual processes.
• In considering individual drugs, both countries have considered the public health experience of the other. If either country has evidence of public health and safety issues, the Working Party has recommended that the higher schedule remain in position, but if availability to the public over-the-counter (OTC) has not created public health problems, the Working Party has supported the lower schedule. For example, the NZ Medicines Classification Committee recently accepted a recommendation to reschedule chloral hydrate, diethylcarbamazine, mupiricin, phenol injection and viprinium from OTC to "prescription only". Conversely, the NDPSC adopted recommendations to reschedule chlorbutol, glucagon, lobelia and lobeline from Schedule 4 to OTC.
• In examining differences in scheduling between Australia and NZ, the Working Party has found that some of the differences have arisen because of the different legislative mechanisms used in the two countries. For example, problems identified to date include differences in control of availability of drugs and poisons by mechanisms other than scheduling; the lack of a mechanism in NZ equivalent to the Appendix C of the SUSDP and listing of certain Schedule 4 drugs (eg benzodiazepines and thalidomide) under the NZ Misuse of Drugs Act.
• The Working Party has identified that the scheduling of some drugs can not be harmonised until there are legislative changes on either side. Anumber of these issues will need to be addressed in the wider discussions of the TTMRA Co-operation Program.
• Further issues related to common definitions, assessment factors and outcomes of rescheduling will be discussed in the next Information Sheet (November 1999).
• The next two meetings of the NDPSC Working Party will be held in Melbourne in September 1999 and in Wellington, New Zealand in February 2000.

Public access to information on harmonisation of scheduling

• The Working Party's Information Sheets and NDPSC decisions related to harmonisation are available on this Internet site.
  • National Drugs and Poisons Schedule Committee <http://www.tga.gov.au/ndpsc/index.htm>

Top of page

New Therapeutic Goods Committee appointed

A number of new members have been appointed to the Therapeutic Goods Committee (TGC) following the expiry of the previous committees three year term. The new committee was appointed with effect from 1 June 1999, and it is expected the Committee will hold its first meeting in September 1999.

The TGC is responsible for advising the Minister on therapeutic goods issues relating to standards, requirements for labelling and packaging and the principles to be observed in their manufacture.

Membership of the new committee and their areas of expertise/representation are as follows:

Name of Member	Representing/Expertise As per Therapeutic Goods Regulations	Existing/New Member
Mr Mike Kimber	Regulation 34 (4A)(a) "a person who is nominated by a body that represents, or a combination of bodies that together represent, the interests of Australian manufacturers of prescription drug products"	existing
Ms Anthea Steans	Regulation 34 (4A) (b) "a person who is nominated to the Minister in writing by a body that represents, or a combination of bodies that together represent, the interests of Australian manufacturers of non-prescription drug products"	existing
Mr Phil Daffy	Regulation 34 (4A) (c) "a person who is nominated to the Minister in writing by a body that represents, or a combination of bodies that together represent, the interests of Australian manufacturers of alternative medicines"	existing
Mr Barry Evers-Buckland	Regulation 34 (4A) (d) "a person who is nominated to the Minister in writing by a body that represents, or a combination of bodies that together represent, the interests of Australian manufacturers of therapeutic devices"	new
Dr Stephen Phillips	Regulation 34 (4A) (e) "a person who is nominated to the Minister in writing by a body that represents, or a combination of bodies that together represent, the interests of consumers of health services"	new
Associate Professor Stephen Locarnini	Regulation 34 (4A) (f) "a person with expertise in microbiology and virology"	existing
Associate Professor Loraine Holley	Regulation 34 (4A)(g) "a person with expertise in biomedical engineering"	new
Associate Professor Bruce Milthorpe	Regulation 34 (4A)(h) "a person with expertise in the biological safety of biomaterials"	new
Professor Milton Hearn	Regulation 34 (4A)(i) "a person with expertise in biotechnology"	existing
Professor Stella O'Donnell (chairperson)	Regulation 34 (4A)(j) "a person with expertise in pharmaceutical sciences"	existing
Dr John Russell	Regulation 34 (4A)(k) "a member of the Health and Food Standards Advisory Committee of Standards Australia"	existing

Top of page

Proposed amendments to the therapeutic goods regulations

Following consultation with industry, the TGA is recommending the following amendments to the Therapeutic Goods Regulations:

1. Non-sterile preserved hydrogel wound dressings On advice from the Therapeutic Device Evaluation Committee, amendments to Schedules 6 and 11 of the Therapeutic Goods Regulations have been recommended to allow for the supply, in Australia, of nonsterile preserved multi-use gel wound dressings (hydrogels) as a listable product with prescribed quality and safety criteria and GMP standards for manufacturers. The proposed amendments do not apply to wound dressings that contain active medicinal substances. Sponsors of these products will be required to meet the prescribed quality and safety criteria, which are detailed in the hydrogel policy document, at the time of application.
2. Bulk Hamamelis Water (Witch Hazel) An amendment to Schedule 7 of the Therapeutic Goods Regulations has been recommended to allow the production of bulk Hamamelis water to be exempt from requiring GMP. This will align the production of bulk Hamamelis water with other oils extracted from herbs by a similar process.
3. Non-Sterile Bandages and Dressings An amendment to Schedule 7 of the Therapeutic Goods Regulations has been recommended to exempt Australian manufacturers of non-sterile bandages from licensing requirements. This will align the Australian manufacturing requirements for non-sterile bandages and dressings with the requirements for overseas manufacturers.

Trans Tasman cooperation

The Special Exemption for therapeutic goods under the Trans Tasman Mutual Recognition Arrangement (TTMRA) has been extended to May 1 2000 following endorsement by the Heads of Governments of Australia and New Zealand of the joint Therapeutic Goods Cooperation Program Report. The Report was prepared by the Therapeutic Goods Administration (TGA) and Medsafe (within the Ministry of Health (MoH) New Zealand) in consultation with industry and consumer organisations.

Trans-Tasman Mutual Recognition Regulations putting the Exemption into effect were adopted by the Commonwealth on 16 April 1999 and by New Zealand and the States and Territories soon after.

Senator Tambling discusses trans Tasman cooperation with New Zealand

The Cooperation Program was the basis for positive discussions between Senator Tambling, Parliamentary Secretary to the Minister for Health and Aged Care and the New Zealand Minister for Health, Hon Wyatt Creech, the Associate Minister for Health, Hon Tuariki Delamere and Dr the Hon Lockwood Smith, Minister for Foreign Affairs and Trade in New Zealand. Matters covered included drugs and poisons scheduling harmonisation, complementary medicines and the implications of the National Review of Drugs and Poisons Legislation for TTMRA. Similar issues were also discussed with Mr Paul Carpenter, Secretary, Ministry of Commerce. Senator Tambling also met with industry representatives.

1999 cooperation report

Work on the Program set out in the report is continuing. Consultation with industry and consumer stakeholders in Australia and New Zealand will take place over the next few months on the preparation of this 1999 Cooperation Program Report. Input will be sought on a sector by sector basis as this year our activities have focussed on particular sectors of the therapeutic goods industry. These include scheduling harmonisation of drugs and poisons, complementary medicines, medical devices and a continuation of the sharing by TGA of its drug evaluation reports for new chemical entities with Medsafe (where the same application has been received in both countries).

Cooperation activities

Scheduling harmonisation - drugs and poisons legislation

Drugs and Poisons scheduling harmonisation is continuing to progress rapidly. A large number of the scheduling changes relating to drugs for human use are being considered by the relevant scheduling committees in each country. This aspect of harmonisation is projected to be completed by the latter half of 2000. In response to a request from Senator Tambling during discussions in New Zealand, Associate Health Minister Delamere has invited an NDPSC member to attend and participate in future meetings of the New Zealand Medicines Classification Committee. Aworkplan for the exploration of prospective harmonisation (ongoing processes that facilitate the alignment of scheduling decisions) is under discussion.

Complementary medicines

New Zealand has taken a strong interest in the Australian Government's package of reforms to complementary medicines regulatory arrangements. The reforms will also assist the process of harmonisation. Information is being exchanged on the development of the new Electronic Lodgement Facility, the role of the Complementary Medicines Evaluation Committee (CMEC) and the Advertising Code Review. Representatives of Medsafe and New Zealand industry have also participated as observers at the first meeting of the Complementary Healthcare Consultative Forum.

The Steering Committee on Harmonisation of Complementary Medicines will soon hold its second meeting. The Committee which includes Government and industry representatives from both countries will meet in New Zealand in conjunction with an industry consultative workshop around harmonisation issues.

Medical devices

Australia and NZ have discussed the development of a joint medical devices register. Ameeting of the Australia New Zealand Medical Device Register held in Canberra in December last year agreed in principle to support the proposed harmonisation of regulatory requirements and eventual implementation of a joint data base for medical devices. These discussions are continuing. Both countries plan to base their individual medical devices classification systems on the EC which uses 'Rules' based on risk to patient and user. Issues relating to the development of a joint register have been identified and discussions are continuing on their resolution.