TGA News Issue 44 (July 2004) - Medicines
Note: The information in this issue of TGA News may no longer be current. Please check with the TGA before relying on the information on these web pages.
Adverse drug reactions bulletin
The April and June 2004 issues of the Australian Adverse Drug Reactions Bulletin <http://www.tga.gov.au/adr/aadrb.htm> are available.
Articles in the June issue <http://www.tga.gov.au/adr/aadrb/aadr0406.htm> include:
- The legacy of diethylstilboestrol (DES) from the 50s and 60s
- Parecoxib - one shot only
- Corticosteroids should be used with longacting β2-agonists
- Atypical antipsychotics and hyperglycaemia
Articles in the April issue <http://www.tga.gov.au/adr/aadrb/aadr0404.htm> include:
- The risks and benefits of HRT
- Macrolides and warfarin interaction
- Bisphosphonates and ocular inflammation
- SSRI antidepressants in children and adolescents
Advertising prescription medicines
Advertisements for therapeutic goods are subject to the requirements of the Therapeutic Goods Act 1989 and Regulations 1990, the Trade Practices Act and other relevant legislation.
Advertising registered prescription medicines to consumers is not permitted, but advertising is permitted to healthcare professionals, within the scope of the legislation. However, prescription medicines not included in the ARTG are considered unregistered therapeutic goods and are therefore not to be advertised in Australia to consumers or healthcare professionals.
More information: Advertising prescription medicines to healthcare professionals <http://www.tga.gov.au/advert/advpmhcp.htm>
ADEC update
The Australian Drug Evaluation Committee (ADEC) released a summary statement on hormone replacement therapy <http://www.tga.gov.au/docs/html/hrtadec3.htm> on 16 April 2004.
ADEC's membership list <http://www.tga.gov.au/docs/html/adec/adec.htm#mship> has been updated and the recommendations from ADEC's 233rd (April 2004) meeting <http://www.tga.gov.au/docs/html/adec/adec0233.htm> are available.
Australian regulatory guidelines for complementary medicines
Drafts of Parts I (Registration of complementary medicines), II (Listed complementary medicines), IV (General guidance) and V (Policy) of the Australian Regulatory Guidelines for Complementary Medicines are available. The consultation period for Parts I and II have closed, but for Parts IV and V the closing date is 23 July 2004.
The final version of Part III (Evaluation of complementary medicine substances) <http://www.tga.gov.au/docs/html/argcm.htm#argcmp3> is also now available.
CMEC 42, 43 & 45
The public recommendation summary for the 45th (April 2004) <http://www.tga.gov.au/docs/html/cmec/cmecdr45.htm> meeting of the Complementary Medicines Evaluation Committee (CMEC) and the extracted ratified minutes of the 42nd (September 2003) and 43rd (November 2003) <http://www.tga.gov.au/docs/html/cmec/cmecdr42.htm> meetings are available.
Colourings permitted in medicines for oral use
A list of colourings permitted in complementary, OTC and prescription medicines for oral use <http://www.tga.gov.au/meds/colourings.htm> is available. The list provides indicative data requirements for the evaluation of new colours for inclusion in medicines for oral use. It replaces Section 4C.4 of the Australian Regulatory Guidelines for OTC Medicines.
Common technical document
From 1 July 2004, the TGA will only accept applications to register prescription medicines in the Common Technical Document (CTD) <http://www.tga.gov.au/docs/html/eugctd.htm> format.
Module 1 of the CTD is currently under revision and a draft of this document was made available for comment. The comment period closed on 21 June 2004.
Modules 3 and 4 were replaced in April 2004.
ELF & listing news
The list of Proprietary ingredients which have been used in listed medicines but which are not usable in ELF 3 until further information is provided <http://www.tga.gov.au/cm/elf3pring.htm> has been updated.
Therapeutic Goods (Listing) Notice No. 1 of 2004 <http://www.tga.gov.au/legis/tgnlist0401.htm> (iron phosphate) was gazetted in June 2004.
Identifcation of herbal materials & extracts
The overarching principle for the identification of herbal starting materials is traceability to a primary source or certified herb.
- See: Questions and answers and flow charts on the identification of herbal materials and extracts <http://www.tga.gov.au/cm/idherbal.htm>
Medicines labelling
As part of the introduction of Therapeutic Goods Order No. 69 General requirements for labels for medicines <http://www.tga.gov.au/docs/html/tgo/tgo69.htm>, on 12 September 2001, transitional arrangements were introduced for products that were already on the market, or were included in an application lodged under section 23 of the Therapeutic Goods Act 1989, before 1 January 2002.
These transition arrangements ceased on 1 July 2004, with the revocation of the following therapeutic goods orders for labelling:
- Therapeutic Goods Order No. 48 General requirements for labels for drug products
- Therapeutic Goods Order No. 62 Amendment to Therapeutic Goods Order No. 48 - General requirements for labels for drug products
Accordingly, from 2 July 2004, all therapeutic goods that are medicines (except those identified in Section 1 of TGO 69) must comply with TGO 69 General requirements for labels for medicines.
Sponsors affected by this change, who need assistance in this regard, should contact the information officer in the appropriate evaluation section of the TGA.
Orphan drugs
Orphan drug products are drugs, vaccines or in vivo diagnostic agents which physicians use to treat, prevent or diagnose rare diseases. The Australian Orphan Drug Program encourages sponsors to market orphan drugs in Australia by reducing costs through waiving fees.
Since the last issue of TGA News, five additions have been made to the list of drugs designated as orphan drugs <http://www.tga.gov.au/docs/html/orphand2.htm>.
Price information code of practice
In April 2004, comments were invited from interested stakeholders on an initiative to permit the publication of price information about medicines available only on prescription, or certain medicines only available with the professional advice of a pharmacist. The Price Information Code of Practice will permit the publication of prices of medicines listed in Schedules 3, 4 and 8 of the Standard for the Uniform Scheduling of Drugs and Poisons. The comment period closed on 21 June 2004.
Stability testing
Questions and answers on the stability testing of Listed complementary medicines <http://www.tga.gov.au/cm/stabilityqa.htm> are available. They are intended to provide additional guidance to sponsors and manufacturers of complementary medicines.