Adverse medicines reactions

The December 2004, February 2005 and April 2005 issues of the Australian Adverse Drug Reactions Bulletin <http://www.tga.gov.au/adr/aadrb.htm> are available.

Articles in the April issue <http://www.tga.gov.au/adr/aadrb/aadr0504.htm>:

• Statins and peripheral neuropathy
• Avascular necrosis with interferon alfa-2b in CML
• Angioedema - still a problem with ACE inhibitors
• Evidence-based medicine: pitfalls of overlooking safety

Articles in the February issue <http://www.tga.gov.au/adr/aadrb/aadr0502.htm>:

• Adverse reactions to complementary medicines
• Avoiding fetal abnormalities with isotretinoin
• Bisphosphonates and osteonecrosis of the jaw
• Statins contraindicated in pregnancy

Articles in the December issue <http://www.tga.gov.au/adr/aadrb/aadr0412.htm>:

• Use of SSRI antidepressants in children and adolescents
• Cardiovascular risk with the selective COX-2 inhibitors
• Propofol: danger of prolonged and high infusion rates in ICU

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ADEC update

Recommendations from the Australian Drug Evaluation Committee's 236th (October 2004) <http://www.tga.gov.au/docs/html/adec/adec0236.htm>, 237th (December 2004) <http://www.tga.gov.au/docs/html/adec/adec0237.htm> and 238th (February 2005) <http://www.tga.gov.au/docs/html/adec/adec0237.htm> meetings are available.

ARGOM

Since the last issue of TGA News, the table Sunscreening agents permitted as active ingredients in listed products in Chapter 10 of the Australian Regulatory Guidelines for OTC Medicines <http://www.tga.gov.au/docs/html/argom.htm> has been updated.

CMEC update

Public recommendation summaries for the 49th (December 2004) <http://www.tga.gov.au/docs/html/cmec/cmecdr49.htm> and 50th (February 2005) <http://www.tga.gov.au/docs/html/cmec/cmecdr50.htm> meetings of the Complementary Medicines Evaluation Committee are available.

Minutes of the 45th, 46th, 47th, 48th and 49th <http://www.tga.gov.au/docs/html/cmec/cmecminu.htm> meetings are also available.

Complementary medicines & the Trans Tasman joint agency

Under the Trans-Tasman therapeutic products agency, products represented to be for therapeutic use are to be regulated as therapeutic products. This includes complementary medicines (such as herbal substances, homoeopathic and related medicines, vitamin and mineral supplements, other nutritional supplements, traditional medicines and aromatherapy oils).

In December 2004, three consultation papers were made available for stakeholder comment. The consultation period closed on 11 March 2005 but the papers are still available on the Trans-Tasman Therapeutic Products Agency Project website <http://www.anztpa.org/cm/index.htm>.

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Compositional guidelines

Compositional guidelines for fish oil from the liver of fish and fish oil from the whole body of fish are available.

Also available are draft compositional guidelines for:

• Amylase derived from Aspergillus oryzae
• Cellulase derived from Trichoderma longibrachiatum
• Lipase derived from Rhizopus oryzae
• Proteases derived from Aspergillus oryzae
• Tilactase derived from Aspergillus oryzae

The consultation period for these draft guidelines closed on 8 April 2005.

European Union guidelines

Guidelines adopted by the TGA are sourced from the Committee for Proprietary Medicinal Products (CPMP) and International Conference on Harmonisation (ICH).

Since the last issue of TGA News, seven new EU Guidelines have been adopted in Australia and two not adopted.

• European Guidelines - Newly Published <http://www.tga.gov.au/docs/html/euguideh.htm#eugwnp>

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Expert Committee on Complementary Medicines in the Health System

The Australian Government response to the review undertaken by the Expert Committee on Complementary Medicines in the Health System was released by the Parliamentary Secretary to the Minister for Health and Ageing, the Hon Christopher Pyne MP, on 9 March 2005. This Response reinforces the Government's prime concern for public health and safety, and that Australians have access to high quality complementary medicines and confidence in using these products.

• Australian Government response to the recommendations of the Expert Committee on Complementary Medicines in the Health System <http://www.tga.gov.au/cm/cmresponse.htm>
• Expert committee report: Complementary Medicines in the Australian Health System <http://www.tga.gov.au/docs/html/cmreport1.htm>

Listed medicines

Therapeutic Goods (Listing) Notices have been gazetted for curcumin (No. 3 of 2004) <http://www.tga.gov.au/legis/tgnlist0403.htm> and fungal enzymes (No. 2 of 2004) <http://www.tga.gov.au/legis/tgnlist0402.htm>.

Medicines labelling

In January 2005, stakeholders were asked to comment on proposed changes to the Required Advisory Statements for Medicine Labels <http://www.tga.gov.au/consult/2005/rasml1.htm>. The consultation period closed on 14 March but details of the proposed changes are still available.

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 last issue of TGA News, two additions have been made to the list of drugs designated as orphan drugs <http://www.tga.gov.au/docs/html/orphand2.htm>.

OTC electronic lodgement system

Consolidated information is available on the OTC medicines electronic lodgement and update of existing ARTG records <http://www.tga.gov.au/npmeds/otc_infosheet.htm>. The document contains

• general information about the OPAL system
• how to access and use it
• how to update existing ARTG records for OTC and registered complementary medicines
• details of supporting evidence required
• how to validate an OTC or registered complementary medicine record using OPAL.

There have been some issues with OPAL regarding:

• overseas manufacturers
• where details are confidential from sponsor
• processing of application details to the ARTG

Overseas manufacturer issues

For some overseas manufacturers, the location details have not been available for selection after input of preclearance numbers. If this occurs, advise the TGA by email (ebs@tga.gov.au; include "OPAL" in the subject) or via the OPAL helpline (1800 616 011). The TGA will then check and update all preclearances for the sponsor to ensure this error does not re-occur.

A number of users have experienced validation failure of Overseas Manufacturer preclearances that they understand to be valid. When such validation failures occur, sponsors are requested to contact the TGA (email ebs@tga.gov.au or helpline 1800 616 011) for further assistance, providing the relevant preclearance and ARTG numbers and failure messages. In some instances these errors are occurring due to data deficiencies in the preclearance database OPAL currently uses to determine manufacturer acceptability.

Where details are confidential from sponsor

Please note that OPAL should currently NOT be used to lodge applications to change current ARTG entries where the entry contains formulation or manufacturer details that are flagged 'Confidential from sponsor'. In such instances, the formulation and/or manufacturer details in the draft applications will appear blank. While new details can be added to enable the application to pass validation, sponsors are requested not to do so, as any confidential information will be deleted altogether from the record when the application is processed. Sponsors are instead requested to hold off drafting and lodging such applications until this system issue is addressed in the near future. If lodging of such applications is urgently required, please contact the TGA for advice. As stated at the roadshows, the TGA will continue to accept paper applications in relation to these products until difficulties with the electronic lodgement process have been resolved.

Processing of application details to the ARTG

Currently the TGA is experiencing a problem that is preventing the writing of application details, including Fee Exempt Update details, to the ARTG after processing. While it is anticipated that this issue will be rectified shortly, if sponsors need a record updated on the ARTG as a matter of urgency (eg they require immediate lodgment of a new application for the same ARTG entry) please contact the TGA to discuss.

Proprietary ingredients form

The Notification of a New Proprietary Ingredient form and guide <http://www.tga.gov.au/docs/html/forms/notifpi.htm> were updated in December 2004.

Please ensure that you are using the updated form.