Australian manufacturers of therapeutic goods - year 2000 compliance

The "Year 2000 issue", or Y2K issue, refers to computer systems and other electronic equipment which may not be able to handle dates beyond the year 1999. Manufacturers of therapeutic goods not achieving Y2K compliance face potentially serious consequences at the commencement of the year 2000.

It is the responsibility of all TGA licensed manufacturers of therapeutic goods who use computerised systems for manufacturing processes to ensure that their systems are Y2K compliant.

During routine GMP audits of each licensed manufacturer, TGA auditors enquire about the company's progress in achieving Y2K compliance. Enquiries to date have revealed that most licensed manufacturers have either achieved Y2K compliance or are well advanced with planning.

In the next few weeks, TGA will be writing to all licensed manufacturers of therapeutic goods seeking written confirmation that they have achieved Y2K compliance and, if not, the date on which Y2K compliance will be achieved.

New advertising arrangements and the Therapeutic Goods Advertising Code

Following a request from the industry, the Regulations to the Therapeutic Goods Act 1989 were amended on 24 December 1997 (Statutory Rules No. 400 of 1997), subsequent to the disbanding of the Media Council of Australia (MCA). These amendments established a new Therapeutic Goods Advertising Code Council (TGACC) which is representative of the community at large. The Council's membership of 12 comprises the therapeutic goods industry (4), health professionals (3), consumer organisations (2), the advertising industry (2) and the TGA(1). The TGACC aims to achieve greater uniformity in advertising approval processes and standards relating to both print and electronic broadcast media.

Amendments to the Regulations also resulted in the establishment of a Complaints Resolution Panel (CRP) which comprises 8 members. These include a chairman nominated by the TGACC, two representatives from the therapeutic goods industry, two representatives from consumer organisations and three persons nominated from professional health care associations. The CRP receives and considers complaints about advertisements, takes appropriate action and makes recommendations to the Secretary/TGA where necessary.

In addition, the Regulations establish an approval scheme for advertisements for medicines intended for publication or insertion in the mainstream print media. The Nutritional Foods Association of Australia (NFAA) has been delegated to approve advertisements relating to complementary medicines, while the Proprietary Medicines Association of Australia (PMAA) has been delegated to approve advertisements for all other nonprescription medicines.

A review of permissible and prohibited advertising claims for over the counter (OTC) therapeutic goods has been undertaken. The TGA, PMAA, NFAA and TGACC participated in the review.

This review culminated in the TGACC recommending to the Hon. T Worth MP, former Parliamentary Secretary to the Minister for Health and Family Services, that some amendments be made to the Therapeutic Goods Advertising Code (TGAC) (eg: qualified reference to gout is now permitted, as is a claim of "may assist blood circulation"). All of the TGACC's recommendations were accepted and the amendments became effective on 5 August 1998.

As the great majority of the new TGAC amendments are of a de-regulatory nature, the effect has been to provide sponsors with a wider scope of advertising claims which may be included in advertisements to the public for nonprescription products.

New GMP for sterile medicines

From 1 January 1999, Part 2 of the Australian Code of GMP for Medicines, which covers the manufacturing requirements for sterile medicines, will be replaced by Annex 1 of the EU GMP Guide for Medicinal Products. This change was endorsed by the Therapeutic Goods Committee earlier this year, and is intended to be the first step towards harmonising Australia's GMP requirements with those of Europe. The next step is to adopt the EU GMP Guide when it is next revised.

Industry Seminars in Sydney and Melbourne have been undertaken to discuss the main differences between the European and Australian GMP requirements for the manufacture of sterile medicines.

Workshop on GMP standards for herbal medicines

Andrew Muir from the GMP Audit and Licensing Section recently conducted a workshop in Guiyang, China on GMP Standards for Herbal Medicines. The workshop was organised by the State Administration for Traditional Chinese Medicine (SATCM) in conjunction with WHO. There were more than a hundred participants most of whom were manufacturers of traditional Chinese medicine (TCM). One of the main outcomes of the workshop was an increased understanding of the need for China to improve the GMP standards of TCM's destined for the export market.