International visitors & training

Over the past few months, the TGA has hosted short-term visits from delegations of overseas regulatory agencies and international organisations from Japan and Malaysia.

The TGA recently completed two collaboration projects with the Indonesian National Agency for Drug and Food Control (NADFC). Several Indonesian officers were trained in Australia on the regulation of medicines and medical devices. The projects were sponsored by AusAID under the Government Sector Linkages Program.

The TGA is to conduct two training courses in late 2004 on pharmacovigilance and vaccine quality assurance under the sponsorship of WHO. More information: TGA upcoming events <http://www.tga.gov.au/about/events.htm>.

International meetings

Annual OMCL meeting

In May 2004, the Paul Erhlich Institute hosted the annual Official Medicines Control Laboratory (OMCL) meeting in Germany.

The OMCL network consists of laboratories that are associated with the medicines regulators of European countries. The TGA and Health Canada have observer status with the network. The value of the network within Europe is that it aims to ensure uniform standards of Good Laboratory Practice are applied in all member countries. It achieves this by coordinating proficiency testing programs (in which TGA Laboratories participates) and through audits.

This year's meeting drew approximately 200 attendees, including senior officers from the laboratories along with technical specialists who were invited to give presentations on aspects of OMCL work.

The main themes of the meeting centred on the increased role of OMCLs under the new European Medicines Directive, especially concerning centralised testing programs and issues relating to accreditation under ISO 17025, particularly where biological testing is concerned. The technical presentations dealt mainly with the developing role of mass spectrometry in pharmaceutical analysis.

Group 1 Expert Committee (Microbiology)

TGA Laboratories' Chief Microbiologist, Vivienne Christ, attended the 41st meeting of the European Pharmacopoeia (EP) Group of Experts No. 1 (Microbiology), held in Strasbourg from 26-28 May 2004.

Through its association as an Official Medicines Control Laboratory (OMCL) under the EDQM network, TGA Laboratories (TGAL) was invited, some years ago, to appoint specialist observers to a number of EP Groups of Experts. Members of these groups contribute technical expertise to the formulation of EP monographs and general methods texts. TGAL's microbiologists have actively contributed to the work of the Group of Experts No. 1 for over seven years.

The primary purpose of the May 2004 meeting was to discuss harmonisation of the Microbial Attributes chapters across the three pharmacopoeial bodies that participate in the International Committee for Harmonisation (ICH). Experts represent the European (EP), United States (USP) and Japanese (JP) pharmacopoeias on the Pharmacopoeial Discussion Group (PDG) subcommittee.

The following draft documents were published in the EP's journal, Pharmeuropa 15.3 (July 2003), for public inquiry:

• Chapter 2.6.12 - Microbiological Examination of Non-Sterile Products: Microbial enumeration tests (Document PA/PH/Exp. 1/T (99) 22 ANP)
• Chapter 2.6.13 - Microbiological Examination of Non-Sterile Products; Tests for specified microorganisms (Document PA/PH/Exp. 1/T (99) 21 ANP); and
• Chapter 5.1.4 - Microbiological Quality of Non-Sterile Pharmaceutical Products (Document PA/PH/SG (01) 98 ANP).

The Experts considered the compilation of comments resulting from this inquiry.

The proposed methods introduce a variety of new media, challenge organisms and incubation conditions, and interpretation of results for both the microbiological enumeration and presence/absence tests for specified microorganisms for non-sterile pharmaceutical products. The methods will be regarded as referee tests and must therefore be followed as written. Laboratories wishing to use alternative media and methods may be able to take advantage of the proposal for a new chapter on rapid microbiological methods and clarification in the General Notices chapter of the EP. The use of an alternative method will depend on a validation study demonstrating that it is at least equivalent to the reference method.

The proposed harmonised microbial quality limits (Chapter 5.1.4) will apply to aqueous and non-aqueous oral preparations, products for rectal, oromucosal, gingival, cutaneous, nasal, auricular and vaginal use, as well as to transdermal patches and inhalations. Limits for both total aerobic microbial count and total combined yeast and mould count, and absences of specified organisms are proposed.

It should be noted that the scope of the harmonisation texts does not include microbiological quality attributes for herbal medicines. However, the EP will reinstate specifications for this group of products in a table in the non-harmonised text. The EP version will also include additional requirements for other oral dosage forms that contain raw material of natural (animal, vegetable or mineral) origin.

It is hoped that the harmonised texts will be signed off at the November 2004 meeting of the PDG Experts and then submitted to the EP Commission for adoption at their meeting in March 2005. The harmonised texts will be published in the new editions of the EP, USP and JP. The British Pharmacopoeia (BP) usually adopts the text of the EP soon after this. In order to allow sufficient time for laboratories to validate and implement the proposed new methods, a transition period of five years is likely to be proposed.

During the meeting, some consideration was given to the resolution of the residual differences in relation to the harmonised Test for Sterility as published in the EP 2003, BP 2003; and USP 27. The Experts considered that it was possible to harmonise on some of the minor issues, such as moisture content of agar etc, but not on major points, such as growth promotion tests on each batch of media and criteria for invalidation of test results. A major change accepted by the Experts was to move the sampling table to the mandatory part of the EP text. The situation will be discussed further with European industry associations and recommendations taken forward to the PDG for approval.

TGAL plans to send a microbiologist to speak at a pharmaceutical symposium at the Australian Society for Microbiology meeting in Sydney on 30 September 2004. The presenter will elaborate details of the discussions held at the Group of Experts No. 1 meeting in Strasbourg during May 2004 and will provide an update on the status of the harmonised microbiological texts.

WHO 2004 southern hemisphere strain selection meeting

On 20-25 September 2004, the Australian Government Department of Health and Ageing, in conjunction with the TGA, will host the World Health Organization 2004 Southern Hemisphere Strain Selection meeting in Canberra.

WHO Global Training Network meeting

The World Health Organization Advisory Committee on Training (WHO ACT) met in Geneva on 6-8 April 2004. The WHO ACT is the body that oversees the Global Training Network (GTN) for vaccine quality assurance.

The WHO ACT meeting discussed ways of improving the global training programs to better serve the needs of countries that do not have adequate regulatory controls in the area of vaccines. Issues around targeting of relevant staff in the countries for which training is to be provided were reviewed, as was the suitability of the content of the various training courses. Funding for the training programs remains a key issue for the WHO and for the training centres.

Since 1997, the TGA has participated in the GTN through provision of several training courses and by supplying scientists to undertake on-site training in several Asian countries. The TGA's fourth GTN course is scheduled for November 2004.