Report on the 16th meeting of the Therapeutic Goods Committee

The Therapeutic Goods Committee (TGC) is a Statutory Committee established under the Therapeutic Goods Act 1989 to advise the Minister for Health on standards for therapeutic goods. At its meeting in Canberra on 22 June 2000, the Committee considered a number of standards issues including:

• progress made by the TGC Labelling Subcommittee in reviewing Therapeutic Goods Order (TGO) No. 48 General Requirements for Labels for Therapeutic Goods;
• a progress report on the revision of TGO No. 20 Child Resistant Containers and TGO No. 33 Amendment of Schedules to TGO No. 20 being undertaken by the TGC Subcommittee on Child Resistant Packaging, whose recommendations are currently being discussed by industry;
• the implementation of 'fresh blood' regulation in Australia. The TGC agreed in principle to a new TGO to cover blood components;
• the adoption of the British Pharmacopoeia 2000;
• a request by the Medicines Evaluation Committee to include oral dosage forms of folic acid in Schedule 2 of TGO No. 56 General Standards for Tablets, Pills and Capsules;
• preservative efficacy in multidose and medical device preparations. TGC endorsed the adoption of guidelines for these products, based on European Agency for the Evaluation of Medicinal Products (EMEA) and Committee for Proprietary Medicinal Products (CPMP) Guidelines with ISO/EN and FDA methodology;
• proposed gazettal of a new TGO for blood bags based on the adoption of Australian Standard AS3787: General Requirements for Single Use, Sterile, Plasticised Polyvinyl Chloride (PVC) Packs for Human Blood.
• the revision of TGO No. 37 General Requirements for Labels for Therapeutic Devices. The Committee endorsed the proposal to bring the labelling requirements for therapeutic devices into line with those recommended by the Medical Devices Global Harmonisation Task Force.

Crisis management plans for industry and regulators

In recent months, two companies which supply over-the-counter medicines to the Australian market have conducted national consumer level recalls of products as a result of criminal tampering and extortion threats. These incidents have highlighted the importance of companies and regulators having in place up-to-date crisis management protocols to address such situations.

A Taskforce comprising representatives from the TGA, therapeutic goods industry associations, the Consumers' Health Forum, the police and State/Territory health authorities has been established to facilitate a systematic approach to these matters. The Taskforce has met 3-4 times since its inception in early June 2000.

There has been agreement on a 'whole of industry' approach to crisis management based on world best practice. The Australian Self-Medication Industry Association (formerly known as the Proprietary Medicines Association of Australia) has agreed to review and refine their existing protocols based on international best practice, to provide model Crisis Management Guidelines for adoption by the therapeutic goods industry as a whole.

A new section referring to Crisis Management will be inserted in the Uniform Recall Procedure for Therapeutic Goods requiring that the TGA be notified in the event of a product tampering threat. As part of the new Crisis Management Plan, the TGA Recalls Co-ordinator will convene a Crisis Reference Group (CRG) comprising representatives of the company, police and relevant health authorities. The CRG will determine an action plan to deal with the crisis - which may or may not involve recall of the product.

The TGA is developing a Crisis Management Plan that meets international best practice by reviewing plans used by other health regulators.

State and Territory health authorities without mechanisms already in place, are establishing mechanisms for the rapid dissemination of information to hospitals in their jurisdictions.

New recalls powers for product tampering

The Therapeutic Goods Act 1989 has been amended to strengthen the TGA recall powers in cases of product tampering. The legislation has been passed through both Houses of Parliament and is in operation.

The Act has been amended to:

• require mandatory reporting to the TGA by sponsors as soon as they become aware of cases of product tampering or implied product tampering;
• give the TGA mandatory recall powers, under specified circumstances, in cases where sponsors refused to recall tampered products; and
• make it an offence to supply or sell goods subject to recall.

New medical device legislation update - information seminars

During June and July 2000, information seminars for industry on the new medical device regulatory system and the new Device Electronic Application Lodgement (DEAL) system were conducted in Sydney, Melbourne, Adelaide and Perth. There was an excellent response to the seminars in all locations. Further seminars were conducted during September 2000 in Sydney and Melbourne on the specific requirements for Class I medical devices and the DEAL system.

The TGA is planning to conduct the next round of information seminars for industry in February/March 2001. It is anticipated that an early draft of the Regulations, which will contain the detail of the new requirements, will be available for discussion by this date. The information seminars on the new legislation will be held in most capital cities.