EXPLANATORY STATEMENT
Subject: MANUFACTURING PRINCIPLES - MP 1/2002
(S.36(1) Therapeutic Goods Act 1989)
The Therapeutic Goods Act 1989 (the Act), which came into effect on 15 February 1991, regulates the establishment and maintenance of a national system of controls relating to the quality, safety and efficacy of therapeutic goods for use in humans.
Section 36 of the Act empowers the Minister to determine, as required, principles to be observed by manufacturers of therapeutic goods relating, inter alia, to standards to be maintained, the procedures to be adopted and the manufacturing practices to be employed in the manufacture of such goods.
Having consulted with the Therapeutic Goods Committee established under the Therapeutic Goods Regulations to, amongst other things, consider principles to be observed in the manufacture of therapeutic goods for human use and to advise the Minister accordingly, the Parliamentary Secretary to the Minister has determined that the Manufacturing Principles specified in MP 1/2002 (attached) will apply to the manufacture of active pharmaceutical ingredients. The purpose of the Manufacturing Principles is to establish the minimum requirements to be observed for the manufacture of active pharmaceutical ingredients for use in the manufacture of medicines for human use.
This Determination adopts the ICH (International Conference on Harmonisation) Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients as a Manufacturing Principle for the audit and licensing of manufacturers of active pharmaceutical ingredients in Australia. The adoption of this document as a Manufacturing Practice will ensure that Australia’s manufacturing requirements for active pharmaceutical ingredients are harmonised with other countries such as USA, Europe, Switzerland, Japan and Singapore. Australian manufacturers of active pharmaceutical ingredients will benefit through increased export opportunities to export their products to many more countries than previously.
The application of the ICH GMP Guide to overseas manufacturers of active pharmaceutical ingredients used in therapeutic goods supplied to Australia will continue to apply only to prescription medicines evaluated by the Drug Safety and Evaluation Branch of TGA.
A 12-month transition period will apply from the time the Guide is gazetted as a Manufacturing Principle.
The Manufacturing Principles MP1/2002 commenced operating on the date of gazettal, which was 29 May 2002 (Gazette No. GN 21).