The Essential Technical & Regulatory E-News– Local & International

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TGA News

Caffeine Labeling

CMEC has recommended that labels on products containing those herbs known to contain caffeine, declare that the goods contain, or may contain caffeine - unless the sponsor can demonstrate the product does not contain caffeine. Homoeopathic medicines more dilute than 1X are exempt from this requirement.

Proposed Scheduling of Neem

The National Drugs and Poisons Scheduling Committee (NDPSC) has agreed to defer any further consideration of the scheduling of Azadirachta indica (Neem) to its next meeting on 15-17 October 2002. The Committee noted that a number of interested stakeholders had not made a public submission on the scheduling of Neem to the February 2002 meeting, as the Gazette notice only referred to a proposal to schedule azadirachtin, one of the pesticidal active components of Neem. Accordingly, the Committee agreed to recommence the public consultation process at the October 2002 NDPSC meeting.  Submissions by COB 4 September 2002. Email - NDPSC@health.gov.au

http://www.health.gov.au/tga/docs/html/ndpsc/neem.htm

Adoption of PIC/S GMP Guide as a Manufacturing Principle

On 16 April 2002, the Therapeutic Goods Committee (TGC) recommended that the current Australian Code of Good Manufacturing Practice (GMP) for Medicinal Products (August 1990 edition) be replaced with the current Pharmaceutical Inspection Cooperation Scheme (PIC/S) GMP Guide for Medicinal Products (15 January 2002 edition).

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. Copies of the current PIC/S GMP Guide for Medicinal Products can be obtained from the PIC/S web site at www.picscheme.org. Seminars see Conferences and Meetings

GMP For Starting Materials

Therapeutic Goods Manufacturing Principles Determination 1 available at - http://www.health.gov.au/tga/docs/pdf/tgmp0201.pdf

TSE Draft Document

The revised draft document on Supplementary Requirements for Therapeutic Goods for minimizing the risk of transmitting spongiform encephalopathy (TSE) has been released for comment (by 30^th August 2002). Revisions include contact lens care products, medicines intended for parenteral, ophthalmic and intra-tracheal administration and implantable medical devices are now required to be submitted to TGA for evaluation rather than self-assessment. http://www.health.gov.au/tga/docs/html/tsesupp.htm

Exporting Medicines from Australia

TGA has made available Guidelines for exporting medicines from Australia http://www.health.gov.au/tga/docs/html/export/expopgui.htm These guidelines should be read in conjunction with the document "Policy for the Export of Medicines from Australia" which outlines the objectives of the Australian regulatory system for export medicines and the relevant legislative framework.

Australian Guidelines for the Registration of Drugs 2 – Supplement 1 Amendments

Guidelines for specific product categories and substances have been amended to include guidelines for ‘family pack’ and ‘metered dose aerosols – spacer devices’ and there is an amended guideline on sodium content for oral products. http://www.tga.health.gov.au/docs/pdf/agrd2sup1.pdf

TGA FEES clarification

An error was made in the new fee schedule for Export certificate and Certificate of GMP Compliance. The fee actually rose from $70 to $75 (not to $150 as was incorrectly entered). The current version of fees is correct http://www.health.gov.au/tga/docs/pdf/fees02.pdf