New manufacturing principle for active pharmaceutical ingredients (APIs)

In June 2001, the Therapeutic Goods Committee recommended that the International Conference on Harmonisation (ICH) Guideline Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients be adopted as a Manufacturing Principle for the auditing and licensing of manufacturers of APIs in Australia. The application of the ICH GMP Guide to overseas manufacturers of APIs used in therapeutic goods supplied to Australia will continue to apply only to prescription medicines evaluated by the Drug Safety and Evaluation Branch of the TGA, until discussions are held with relevant industry groups about the need to apply GMP to overseas manufactured APIs used in specific over-the-counter products supplied in Australia.

A 12-month transition period will apply from the time the Guide becomes a Manufacturing Principle, which is expected to be sometime in October 2001.

The development of the ICH GMP Guide for APIs originated from an international conference convened by the TGA in Canberra in 1996. At this conference, agreement was obtained to commence work on the preparation of an internationally harmonised GMP for APIs. The TGA prepared the first draft of the document, which was provided to the Pharmaceutical Inspection Convention (PIC) for further refinement. PIC eventually handed the document to ICH for finalisation. The TGA has had representatives at all meetings of PIC and ICH during the development of this GMP Guide.

Progress on Australia-EC mutual recognition agreement (MRA) - medicinal products GMP inspection & batch certification

In June 2001, regulators from Australia, New Zealand and the European Community (EC) met in Brussels to progress the Sectoral Annex on Medicinal Products GMP Inspection and Batch Certification of the Australia-EC MRA. Some of the key points discussed at this meeting included:

• Finalisation of the transition arrangements previously applying to veterinary medicinal products. It was agreed that from 1 July 2001 the MRA would be fully operational for these products, ie veterinary products exported to Europe will no longer require "re-analysis" on arrival in Europe.
• Finalisation of the format of the GMP certificate to be exchanged under the MRA (it should be noted by Australian sponsors that under the MRA the exporter, importer or competent authority may request GMP certificates).
• Finalisation of the format for an internationally harmonised batch certificate. These certificates are required to accompany each batch of product exported to Europe.
• Commencement of drafting a Maintenance Program describing the procedures to be followed by regulators for the ongoing maintenance of the Sectoral Annex on Medicinal Products GMP Inspection and Batch Certification, including exchange of information, joint visits, joint training and maintaining mutual confidence.

A Guide for Australian manufacturers and exporters on the EC-MRA Sectoral Annex on Medicinal Products GMP Inspection & Batch Certification <http://www.tga.gov.au/international/ecmra.htm>, including the format of the GMP certificate and batch certificate is available.

Proposal to adopt PIC/S GMP guide as a manufacturing principle

The TGA is consulting with industry associations on the proposal that the Pharmaceutical Inspection Convention Scheme (PIC/S) GMP Guide for Medicinal Products be adopted as a Manufacturing Principle early next year.

The PIC/S GMP Guide is virtually identical to the European Community (EC) GMP Guide. The main difference being the use of the term "authorised person" in the PIC/S Guide and "Qualified Person" in the EC GMP Guide.

In the Asia/Pacific region, New Zealand, Singapore and Malaysia have already adopted the PIC/S GMP Guide, with Taiwan to adopt the Guide next year.

As with any new Manufacturing Principle, a 12-month transition period will apply from the commencement date of the Manufacturing Principle. The TGA will initiate training seminars for industry during the transition period and develop interpretive guidelines on key areas of the Guide for the information of industry.

Copies of the PIC/S GMP Guide for Medicinal Products can be obtained from the PIC/S website <http://www.picscheme.org>.